Abstract
Background:
This study aimed to evaluate the effects of different doses of dexmedetomidine and propofol on sedation, hemodynamic changes, and postoperative complications in patients undergoing ovarian puncture surgery.
Materials and Methods:
This randomized controlled trial was conducted on 96 women candidates for ovarian puncture surgery. In the first group (DEX-0.5), a bolus dose of dexmedetomidine 0.5 µg/kg was administered for the induction of anesthesia, followed by a maintenance dose of dexmedetomidine 0.5 µg/kg/min. In the second group (DEX-1), a bolus dose of dexmedetomidine 1 µg/kg was administered for induction, followed by a maintenance dose of dexmedetomidine 1 µg/kg/min. In the third group (control group), propofol 50 µg/kg/min was administered for induction of anesthesia.
Results:
SBP, DBP, and MAP were significantly lower in the control group compared to the other groups (P value < 0.05). The mean scores of patient and surgical satisfaction levels in the DEX-0.5 group were significantly higher than the control group (4.00 ± 1.02 and 4.41 ± 0.57, respectively) and in the DEX-1 group (6.00 ± 1.35 and 4.61 ± 0.56, respectively) compared to the control group (2.90 ± 2.10 and 3.10 ± 0.32, respectively) (P value < 0.05). Need for additional analgesics was significantly higher in the control group compared to the intervention groups (P value < 0.05).
Conclusion:
It seems that the administration of dexmedetomidine 1 µg/kg, due to better pain relief, higher satisfaction, less need for additional analgesics, and minimal occurrence of complications, can be recommended as a safe and effective dose in ovarian puncture surgery.
Keywords: Dexmedetomidine, hemodynamics, pain ovarian, propofol, puncture
INTRODUCTION
Although ovarian puncture or oocyte retrieval is considered a simple and outpatient surgery, like other surgeries, it can be associated with changes in hemodynamic parameters and the occurrence of complications induced by anesthesia.[1,2] Now, considering that the time of awakening and emergence from anesthesia, the duration of stay in recovery, and various side effects such as pain, nausea, vomiting, dizziness, and overall patient satisfaction are very important and effective in early discharge or the occurrence of surgical complications.[2,3,4]
In this regard, various drugs have been available and studied to improve anesthesia conditions and postoperative recovery. The use of various opioids alongside anesthetics such as propofol is common, but due to various side effects of these drugs such as respiratory suppression, hypoxia, and apnea, efforts to find better options continue.[5,6]
Propofol is a short-acting injectable drug with hypnotic and amnestic effects used for induction and maintenance of anesthesia.[7] Propofol, in comparison to other anesthetics, produces the most significant decrease in systemic blood pressure, which becomes more evident with increasing age or rapid injection.[8]
Another notable drug is dexmedetomidine, which is a selective α-2 adrenoreceptor agonist with high potency.[9] Dexmedetomidine can maintain its analgesic and sedative properties without causing respiratory depression. Activation of α-2 receptors inhibits the sympathetic center, leading to hypotension, bradycardia, and intraoperative stabilization of patient hemodynamics, also reducing the need for opioids. Additionally, this drug reduces shivering in patients.[10,11] Because of its minimal effect on patient respiration, it is used as a part of anesthesia to prevent and treat delirium and as one of the sedative drugs in intensive care units.[12,13]
Regarding oocyte retrieval surgery, numerous reports have pointed to the potential impact of anesthesia agents on oocyte fertilization and embryo quality. Drugs such as propofol, dexmedetomidine, thiopental, midazolam, fentanyl, and alfentanil, along with local anesthetics, may accumulate in follicular fluid and may affect the structure of the oocyte and subsequent embryo growth.[14,15,16] Therefore, according to available evidence, the use of these drugs does not seem to have adverse effects on the outcome of this surgery and is not subject to prescription restrictions.[17,18]
On the other hand, it is noteworthy that very few and rare studies have been conducted on the effects of various anesthetic drugs such as propofol, remifentanil, or dexmedetomidine on the procedures of oocyte retrieval, and the results obtained are not widely generalizable to the population. Therefore, it seems that conducting more studies to achieve more accurate results and select an appropriate drug is necessary. For this purpose, this study aimed to compare the effects of dexmedetomidine and propofol doses on anesthesia during surgery, hemodynamic changes, postoperative nausea and vomiting, and recovery duration in patients undergoing oocyte retrieval surgery in the infertility ward of Shahid Beheshti Hospital in Isfahan.
MATERIALS AND METHODS
Study design and patients
In this randomized controlled clinical trial study population consisted of all women referred to the infertility ward of Beheshti Hospital in Isfahan in the years 2023–2024.
With a confidence level of 95%, test power of 80%, and considering the results of previous studies,[19] which indicated a pregnancy rate of 19.4% (P1) and 27.7% (P2) in two equal groups, and considering the error rate (d) of 0.3, a sample size of 32 subjects was considered in each group.
Inclusion and exclusion criteria
The inclusion criteria for the study included infertile women candidates for puncture surgery with IVF/ICSI indication, aged over 25 years, and ASA class I or II. In addition, those with allergies to any of the drugs used, a history of diseases (such as epilepsy, gastric reflux, severe cardiovascular disease, and atrial fibrillation or stroke), and those with a change in anesthesia technique, drug sensitivity during anesthesia, or unwillingness to continue participating in the study were not included in the study.
Intervention
A total of 96 eligible mothers were selected using random sampling and enrolled in the study after obtaining written consent. Upon entry into the study, their demographic information including age, underlying diseases, previous history of obstetrics problems and childbirth, prior fertility, hormonal profiles, and current and previous treatment protocols were collected and recorded. Subsequently, using random allocation software, the women were divided into three groups [Figure 1].
Figure 1.
Consort flowchart of patients
For all patients, the puncture surgery protocol was uniformly performed. Additionally, all patients were administered midazolam 0.05 mg/kg and fentanyl 2 µg/kg. Furthermore, in the first group (DEX-0.5), a bolus dose of dexmedetomidine 0.5 µg/kg was administered for anesthesia induction, followed by a maintenance dose of dexmedetomidine 0.5 µg/kg per minute.
In the second group (DEX-1), a bolus dose of dexmedetomidine 1 µg/kg was administered for anesthesia induction, followed by a maintenance dose of dexmedetomidine 1 µg/kg per minute.
In the third group (control group), propofol 50 µg/kg was administered for anesthesia induction.
It is worth mentioning that to ensure blindness conditions, different doses of drugs were prepared in identical syringes that previously labeled with codes by the anesthesiology resident and provided to the researcher daily without their knowledge of the type of drugs. Additionally, the patient was unaware of the type of intervention in each of the groups. The data collector and statistician were also unaware of the type of intervention in each group.
Moreover, in case the patient’s movement interfered with the surgical procedure, additional intervention was performed as repeated doses of midazolam 0.2 mg/kg and ketamine 0.2 mg/kg.
The hemodynamic parameters of the patients [including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), and oxygen saturation (SPO2)] were evaluated and recorded before the intervention, and then at 5, 10, and 15, and 30 minutes after the intervention, and then every 15 minutes during recovery until discharge from the hospital.
The occurrence of adverse events including hypertension and hypotension, tachycardia and bradycardia (20% change from baseline), bradypnea (RR < 8 bpm), apnea, hypoxia, and respiratory depression were also recorded.
In case of tachycardia, if there were no contraindications for administration, labetalol was used with a bolus dose of 2.5 mg. In case of bradycardia, atropine was used with a bolus dose of 0.5 mg, and in case of hypotension, epinephrine was used with a bolus dose of 5 mg, and in case of hypertension, if there were no contraindications for administration, nitroglycerin (TNG) was used with a bolus dose of 100 µg, or labetalol was used with a bolus dose of 5 mg.
It is worth mentioning that the patients’ pain after the surgical procedure was evaluated using the Evaluation of Acute Pain Objective measure. In this regard, if there was insufficient pain relief and pain during rest, a score of one was given. Also, in the absence of pain during rest and normal breathing, a score of 2 was given, in the absence of pain during deep breathing but pain during coughing, a score of 3 was given, and in the absence of pain even during coughing, a score of 4 was given.
Furthermore, the occurrence of side effects such as postoperative nausea and vomiting (PONV) was recorded. The severity of PONV was determined using the Visual Analog Scale (VAS) ranging from 0 to 10. Ondansetron 4 milligrams intravenously was used for the control of nausea and vomiting.
The level of sedation was assessed using the Ramsay Sedation Scale as follows: Score 1: Awake; agitated or restless or both, Score 2: Awake; cooperative, oriented, and tranquil, Score 3: Awake but responds to commands only, Score 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus, Score 5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus, and Score 6: Asleep; no response to glabellar tap or loud auditory stimulus.
Additionally, patient and surgeon satisfaction upon discharge from recovery was evaluated and recorded using the VAS scale ranging from zero to 10.
The duration of anesthesia (from the administration of the anesthetic drug to its cessation), surgical duration (from the start to the end of the procedure), and recovery room stay duration were assessed and recorded based on the Modified Aldrete criteria.
Data analysis
Finally, the collected data were entered into the SPSS software (Version 26). Descriptive statistics such as mean, standard deviation, frequency, and percentage were used. For inferential statistics, one-way analysis of variance (ANOVA) was employed to compare the means of quantitative variables among the three groups, and Tukey’s post hoc test was used for pairwise group comparisons. Furthermore, the Chi-square test was utilized to compare the frequency distribution of qualitative data. A significance level of less than 0.05 was considered for all analyses.
RESULTS
In the present study, the age of patients in the DEX-0.5, DEX-1, and control groups was 36.90 ± 4.47 years, 37.23 ± 6.89 years, and 34.89 ± 4.99 years, respectively (P value > 0.05). Generally, the three study groups did not significantly differ in terms of baseline and clinical characteristics and were homogeneous (P value > 0.05) [Table 1].
Table 1.
Baseline and clinical characteristics of patients in the three groups
| Characteristics | DEX-0.5 group (n=32) | DEX-1 group (n=32) | Control group (n=32) | P | ||||
|---|---|---|---|---|---|---|---|---|
| Age; year | 36.90±4.47 | 37.23±6.89 | 34.89±4.99 | 0.240 | ||||
| Weight; kg | 70.96±8.53 | 68.50±11.16 | 67.25±11.78 | 0.510 | ||||
| Past medical history | ||||||||
| DM | 1 (3.1%) | 1 (3.1%) | 0 (0%) | 0.518 | ||||
| Hypothyroid | 5 (15.6%) | 9 (28.1%) | 6 (18.7%) | |||||
| HTN | 0 (0%) | 0 (0%) | 1 (3.1%) | |||||
| Surgery Duration; min | 7.47±2.33 | 10.39±6.81 | 10.03±10.14 | 0.213 | ||||
| Duration of Anesthesia; min | 12.59±2.92 | 14.84±6.64 | 13.87±9.46 | 0.051 | ||||
| Previous anesthesia | ||||||||
| General anesthesia | 19 (59.4%) | 22 (68.7%) | 18 (56.2%) | 0.414 | ||||
| Spinal anesthesia | 1 (3.1%) | 0 (0%) | 0 (0%) | |||||
| Epidural anesthesia | 1 (3.1%) | 0 (0%) | 0 (0%) |
On the other hand, the mean values of hemodynamic parameters (including SBP, DBP, MAP, HR, RR, and SPO2) did not significantly differ among the three groups before the intervention (P value > 0.05). However, SBP, DBP, and MAP were significantly lower in the control group than in the DEX-0.5 and DEX-1 groups upon entry into recovery and at the fifteenth minute and discharge (P value < 0.05). Furthermore, the pre intervention changes in these three parameters to the time of discharge were significant in the control and DEX-0.5 groups (P value < 0.05), while these changes were not considerable and significant in the DEX-1 group (P value > 0.05). HR was significantly higher in the control group than in the DEX-0.5 and DEX-1 groups at the fifth and tenth minutes after the intervention, with the mean values of 88.67 ± 38.84 bpm and 88.33 ± 34.12 bpm, respectively, compared to 86.33 ± 11.14 bpm and 81.89 ± 9.61 bpm in the DEX-0.5 group, and 73.20 ± 12.66 bpm and 71.60 ± 13.52 bpm in the DEX-1 group (P value < 0.05). HR remained higher in the control group than in the intervention groups upon entry into recovery, at the 15th minute, and at discharge (P value < 0.05). In the intragroup comparison, it was shown that the administration of dexmedetomidine (at both doses of 0.5, 1 µg/kg) could play a significant role in the stability of heart rate. On the other hand, the patients’ RR and SPO2 did not significantly differ among the three study groups and showed no significant changes over time (from before the intervention to discharge) (P value > 0.05) [Table 2].
Table 2.
Determination and comparison of mean hemodynamic parameters in the three study groups
| Variables | DEX-0.5 group (n=32) | DEX-1 group (n=32) | Control group (n=32) | P1 | P2 | P3 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Systolic blood pressure; mmHg | ||||||||||||
| Before intervention | 152.00±22.98 | 142.33±0.58 | 126.22±9.92 | 0.976 | 0.256 | 0.361 | ||||||
| 5 minutes after intervention | 126.20±18.02 | 126.67±9.29 | 118.44±11.45 | 0.629 | 0.123 | 0.187 | ||||||
| 10 minutes after intervention | 122.40±17.44 | 130.00±19.00 | 114.78±15.48 | 0.895 | 0.707 | 0.927 | ||||||
| 15 minutes after intervention | 112.60±14.62 | 134.67±7.09 | 109.78±15.35 | 0.621 | 0.772 | 0.965 | ||||||
| 30 minutes after intervention | 111.20±12.87 | 125.33±8.02 | 108.56±14.80 | 0.350 | 0.934 | 0.185 | ||||||
| In recovery room | 113.00±14.59 | 121.67±17.04 | 112.11±12.11 | 0.635 | 0.005 | <0.001 | ||||||
| 15 minutes in recovery | 110.00±16.15 | 115.67±10.69 | 114.00±10.75 | 0.906 | <0.001 | <0.001 | ||||||
| Upon discharge | 116.60±14.35 | 118.33±9.61 | 116.33±9.11 | 0.876 | 0.002 | 0.001 | ||||||
| P4 | <0.001 | 0.058 | <0.001 | |||||||||
| Diastolic blood pressure; mmHg | ||||||||||||
| Before intervention | 78.40±14.19 | 80.33±11.06 | 76.67±8.76 | 0.513 | 0.362 | 0.087 | ||||||
| 5 minutes after intervention | 76.40±21.66 | 79.33±8.62 | 67.67±9.72 | 0.940 | 0.099 | 0.193 | ||||||
| 10 minutes after intervention | 74.80±13.99 | 80.00±17.78 | 67.89±9.85 | 1.00 | 0.941 | 0.940 | ||||||
| 15 minutes after intervention | 71.00±11.89 | 85.67±10.02 | 65.11±12.92 | 0.707 | 0.743 | 0.998 | ||||||
| 30 minutes after intervention | 69.20±8.98 | 71.67±8.66 | 62.33±13.23 | 0.775 | 0.550 | 0.260 | ||||||
| In recovery room | 72.40±15.66 | 72.00±9.54 | 67.11±13.06 | 0.494 | 0.032 | 0.001 | ||||||
| 15 minutes in recovery | 70.00±2.65 | 75.00±8.54 | 66.60±14.47 | 0.869 | <0.001 | <0.001 | ||||||
| Upon discharge | 70.80±13.06 | 75.00±10.82 | 67.89±6.23 | 0.980 | 0.044 | 0.045 | ||||||
| P4 | 0.035 | 0.500 | 0.041 | |||||||||
| Mean arterial pressure; mmHg | ||||||||||||
| Before intervention | 116.80±17.27 | 115.33±3.78 | 115.44±11.30 | 0.647 | 0.635 | 0.982 | ||||||
| 5 minutes after intervention | 101.20±21.05 | 102.33±9.81 | 100.78±9.23 | 0.996 | 0.871 | 0.257 | ||||||
| 10 minutes after intervention | 93.20±11.86 | 101.67±15.31 | 86.00±14.29 | 0.894 | 0.501 | 0.264 | ||||||
| 15 minutes after intervention | 85.80±11.52 | 105.00±6.93 | 79.89±12.17 | 0.623 | 0.175 | 0.632 | ||||||
| 30 minutes after intervention | 81.80±10.03 | 96.67±3.21 | 78.00±15.92 | 0.304 | 0.122 | 0.865 | ||||||
| In recovery room | 88.80±17.59 | 92.33±14.50 | 85.78±9.92 | 0.582 | 0.154 | 0.015 | ||||||
| 15 minutes in recovery | 79.80±12.52 | 85.33±5.51 | 84.56±10.13 | 0.692 | <0.001 | <0.001 | ||||||
| Upon discharge | 87.20±15.16 | 88.33±10.41 | 81.89±8.96 | 0.831 | 0.036 | 0.022 | ||||||
| P4 | <0.001 | 0.065 | <0.001 | |||||||||
| Heart rate; bpm | ||||||||||||
| Before intervention | 95.00±19.72 | 81.60±22.02 | 103.67±42.54 | 0.698 | 0.154 | 0.542 | ||||||
| 5 minutes after intervention | 86.33±11.14 | 73.20±12.66 | 88.67±38.84 | 0.956 | <0.001 | <0.001 | ||||||
| 10 minutes after intervention | 81.89±9.61 | 71.60±13.52 | 88.33±34.12 | 0.939 | 0.009 | 0.022 | ||||||
| 15 minutes after intervention | 80.33±9.03 | 69.20±8.70 | 89.00±27.49 | 0.533 | 0.133 | 0.630 | ||||||
| 30 minutes after intervention | 82.00±11.55 | 67.00±8.37 | 89.67±26.31 | 0.102 | 0.168 | 0.695 | ||||||
| In recovery room | 83.00±11.18 | 74.00±10.70 | 93.00±23.25 | 0.825 | 0.002 | <0.001 | ||||||
| 15 minutes in recovery | 81.11±12.19 | 74.40±6.23 | 90.33±22.68 | 0.923 | 0.007 | 0.020 | ||||||
| Upon discharge | 82.56±8.49 | 76.00±6.12 | 82.67±15.82 | 0.926 | <0.001 | <0.001 | ||||||
| P4 | 0.247 | 0.383 | 0.006 | |||||||||
| RR; bpm | ||||||||||||
| Before intervention | 14.40±0.89 | 13.33±1.15 | 14.22±1.56 | 0.897 | 0.601 | 0.603 | ||||||
| 5 minutes after intervention | 12.80±1.09 | 12.00±1.00 | 12.00±1.12 | 0.983 | 0.430 | 0.430 | ||||||
| 10 minutes after intervention | 13.20±1.10 | 12.00±1.11 | 12.00±1.00 | 0.234 | 0.271 | 1.00 | ||||||
| 15 minutes after intervention | 13.20±1.11 | 12.00±1.20 | 11.89±0.78 | 0.234 | 0.148 | 0.998 | ||||||
| 30 minutes after intervention | 13.00±1.00 | 12.00±1.03 | 11.80±0.67 | 0.186 | 0.058 | 0.894 | ||||||
| In recovery room | 12.40±0.89 | 12.22±0.67 | 12.00±1.00 | 0.839 | 0.151 | 0.045 | ||||||
| 15 minutes in recovery | 12.40±0.89 | 12.67±1.15 | 12.33±0.71 | 0.968 | 0.108 | 0.174 | ||||||
| Upon discharge | 12.60±0.90 | 12.67±1.15 | 12.44±0.73 | 0.965 | 0.078 | 0.106 | ||||||
| P4 | 0.168 | 0.249 | 0.087 | |||||||||
| SPO2; % | ||||||||||||
| Before intervention | 99.80±0.45 | 99.80±0.40 | 99.00±2.00 | 0.448 | 0.187 | 0.846 | ||||||
| 5 minutes after intervention | 99.20±1.79 | 99.60±0.10 | 99.11±1.26 | 0.281 | 0.922 | 0.486 | ||||||
| 10 minutes after intervention | 99.60±0.55 | 100.00±0.00 | 99.67±0.71 | 0.163 | 0.903 | 0.386 | ||||||
| 15 minutes after intervention | 100.00±0.12 | 100.00±0.00 | 99.56±0.73 | 0.628 | 0.276 | 0.793 | ||||||
| 30 minutes after intervention | 99.80±0.45 | 100.00±0.00 | 99.67±1.00 | 0.937 | 0.951 | 0.806 | ||||||
| In recovery room | 99.80±0.46 | 99.67±0.58 | 99.00±1.66 | 0.325 | 0.408 | 0.992 | ||||||
| 15 minutes in recovery | 100.00±0.50 | 100.00±0.00 | 99.11±0.93 | 0320 | 0.922 | 0.959 | ||||||
| Upon discharge | 99.20±1.09 | 99.67±0.58 | 98.78±1.64 | 0.260 | 0.598 | 0.054 | ||||||
| P4 | 0.565 | 0.600 | 0.708 |
P1: Significance level obtained from comparing the mean of the variable between the two DEX-0.5 and DEX-1 groups at each follow-up time using the Tukey post hoc test. P2: Significance level obtained from comparing the mean of the variable between the DEX-0.5 and control groups at each follow-up time using the Tukey post hoc test. P3: Significance level obtained from comparing the mean of the variable between the DEX-1 and control groups at each follow-up time using the Tukey post hoc test. P4: Significance level obtained from comparing the mean of the variable over time (from before the intervention to discharge) in each of the three study groups using repeated measure analysis
Additionally, in the examination of post-operative pain distribution in pairwise comparisons of the groups, it was found that the pain distribution did not significantly differ between the DEX-0.5 and DEX-1 groups (P value = 0.729). However, the pain level in the control group was significantly higher than in both the DEX-0.5 and DEX-1 groups (P value < 0.05) [Table 3].
Table 3.
Determination and comparison of mean pain in patients in the three study groups
| Pain | DEX-0.5 group (n=32) | DEX-1 group (n=32) | Control group (n=32) | P1 | P2 | P3 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 5 (15.7%) | 3 (9.4%) | 12 (37.5%) | 0.729 | 0.040 | 0.017 | ||||||
| 2 | 10 (31.2%) | 8 (25%) | 9 (28.1%) | |||||||||
| 3 | 7 (21.9%) | 10 (31.2%) | 8 (25%) | |||||||||
| 4 | 10 (31.2%) | 11 (34.4%) | 3 (9.4%) |
Pain score based on the Evaluation of Acute Pain Objective criterion includes: 1: Inadequate pain relief and pain at rest; 2: No pain at rest and normal breathing; 3: No pain at deep breathing but pain at coughing; 4: No pain even at coughing. 1: Significance level obtained from comparing the frequency distribution of pain between the DEX-0.5 and DEX-1 groups using the Fisher’s exact test. 2: Significance level obtained from comparing the frequency distribution of pain between the DEX-0.5 and control groups using the Fisher’s exact test. 3: Significance level obtained from comparing the frequency distribution of pain between the DEX-1 and control groups using the Fisher’s exact test
Finally, the sedation level of patients based on the Ramsay Sedation Scale criterion did not significantly differ among the three groups (P value > 0.05). Although the incidence of adverse events (including PONV, shivering, tachycardia, and bradycardia) was higher in the control group than in the other two groups, due to the low frequency distribution of adverse events, no significant difference was found among the three groups (P value > 0.05). The satisfaction level of patients and surgeons in the DEX-0.5 group, with mean values of 4.00 ± 1.02 and 4.41 ± 0.57, respectively, and in the DEX-1 group, with mean values of 6.00 ± 1.35 and 4.61 ± 0.56, respectively, was significantly higher than in the control group, with mean values of 2.90 ± 2.10 and 3.10 ± 0.32, respectively (P value < 0.05). The time to first administration of additional analgesia in the control group, with a mean of 10.00 ± 6.18, was significantly shorter than in both the DEX-0.5 and DEX-1 groups, with means of 14.50 ± 8.32 and 30.00 ± 6.37, respectively (P value < 0.05). Additionally, the dose of additional analgesia was significantly higher in the control group than the both intervention groups (P value < 0.05) [Table 4].
Table 4.
Determination and comparison of patient outcomes in the three study groups
| Variables | DEX-0.5 group (n=32) | DEX-1 group (n=32) | Control group (n=32) | P1 | P2 | P3 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| RSS | 5 (4–6) | 5 (4–6) | 5 (4–5) | 0.711† | 0.351† | 0.126† | ||||||
| Side effect | ||||||||||||
| PONV | 2 (6.2%) | 1 (3.1%) | 4 (12.5%) | |||||||||
| Shivering | 2 (6.2%) | 1 (3.1%) | 5 (15.6%) | 0.459†† | 0.736†† | 0.644†† | ||||||
| Tachycardia | 0 (0%) | 0 (0%) | 2 (6.2%) | |||||||||
| Bradycardia | 0 (0%) | 1 (3.1%) | 1 (3.1%) | |||||||||
| Patient satisfaction | 4.00±1.02 | 6.00±1.35 | 2.90±2.10 | <0.001† | <0.001† | <0.001† | ||||||
| Surgeon’s satisfaction | 4.41±0.57 | 4.61±0.56 | 3.10±0.32 | 0.320† | 0.003† | 0.040† | ||||||
| Time to first analgesic medication; min | 30.00±6.37 | 14.50±8.32 | 10.00±6.18 | <0.001† | <0.001† | 0.019† | ||||||
| Dosage of opioid analgesic medication*; mg | 3.11±1.09 | 1.20±1.17 | 5.00±1.02 | 0.077† | <0.001† | <0.001† |
Data shown mean ± SD or n (%) or median [IQR]. Ramsay Sedation Scale (RSS) including 1: Awake; agitated or restless or both; 2: Awake; cooperative, oriented, and tranquil; 3: Awake but responds to commands only; 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus; 5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus; 6: Asleep; no response to glabellar tap or loud auditory stimulus. PONV: Post-operative nausea and vomiting. *: Paracetamol, Ketorolac, Propofol. P1: Significance level resulting from comparing the mean or frequency distribution of the variable between the two groups DEX-0.5 and DEX-1 (†: using Tukey’s follow-up test and ††: using the Fisher’s exact test). P2: Significance level resulting from comparing the mean or frequency distribution of the variable between the two groups DEX-0.5 and control (†: using Tukey’s follow-up test and ††: using the Fisher’s exact test). P3: Significance level resulting from comparing the mean or frequency distribution of the variable between the two groups DEX-1 and control (†: using Tukey’s follow-up test and ††: using the Fisher’s exact test)
DISCUSSION
The results of this study showed that the administration of dexmedetomidine at doses of 0.5 and 1 µg/kg maintained the blood pressure in higher levels than the control group, so that at admission to recovery, at the 15th minute, and at discharge, the mean blood pressure of patients in the two dexmedetomidine recipient groups was significantly higher than the control group. Furthermore, with the administration of dexmedetomidine, the stability of heart rate (HR) was also higher than the control group, and both intervention groups had lower HR levels. While the mean respiratory rate (RR) and SPO2 of patients among the three study groups did not show a significant difference.
In this regard, Nazemroaya et al.[18] also demonstrated in their study that the changes in blood pressure, heart rate, respiration, and level of consciousness did not significantly differ between the two dexmedetomidine administration groups (with doses of 1 µg/kg and maintenance dose of 0.3 µg/kg) and midazolam. Additionally, the results of another study indicated that in terms of hemodynamic control, the anesthetic effects of dexmedetomidine (0.5–1 µg/kg) are superior to propofol and reduce the stress response.[20] It is worth mentioning that in this study, all patients received midazolam anesthesia, and the control group also received propofol. Therefore, the results of this study can be considered similar to this study.
Silpa et al.[21] also showed in their examination of two doses of 0.5 and 1 µg/kg dexmedetomidine for reducing hemodynamic response to intubation in patients undergoing elective cardiac surgery that dexmedetomidine at a dose of 1 µg/kg was more effective than 0.5 µg/kg for attenuating the hemodynamic stress response to intubation in cardiac surgery. They stated that increasing the dose of dexmedetomidine could be more effective in controlling hemodynamic responses, which contradicts this study; although in our study, the stability of hemodynamic parameters in the DEX-1 group was higher than the DEX-0.5 group, this difference was not considerable or significant.
Another study comparing the effects of dexmedetomidine with propofol on hemodynamics in critically ill surgical patients showed that the HR and mean arterial pressure (MAP) in the dexmedetomidine group were significantly lower than the propofol group (as the control group), which is consistent with our study.[22]
On the other hand, with the administration of dexmedetomidine at both doses of 0.5 and 1 µg/kg, patients’ pain was better controlled compared to the control group, and no difference could be observed between the two doses of dexmedetomidine. This led to the first administration of additional analgesics in the control group significantly earlier than in the two dexmedetomidine groups. It is noteworthy that the time to the first administration of additional analgesics in the DEX-1 group was significantly less than the DEX-0.5 group. Additionally, the mean dose of additional analgesics was significantly higher in the control group than the two intervention groups.
Consistent with the present study, Elnabtity et al.[17] also showed that dexmedetomidine, compared to midazolam, is associated with a decreased demand for propofol prescription. In fact, dexmedetomidine administration was more successful in pain control. They stated that from an anesthetic perspective, the use of dexmedetomidine in sedation and hemodynamic stability of patients undergoing ovarian puncture procedures will be effective and useful.
Tang et al.[23] also mentioned in their study on dexmedetomidine in acute pain management after surgery as an adjunctive non-opioid analgesic that this drug can play its role in pain relief and assistance through various mechanisms at every stage of the postoperative period. However, dexmedetomidine also has potential side effects such as hypotension and bradycardia that need to be considered when prescribing. Therefore, they recommended further studies to determine safe and optimal doses with maximum benefits and minimal side effects.
Dexmedetomidine is an alpha-2 adrenergic receptor agonist that can directly act on the peripheral nervous system.[20] This drug, used as an adjunct in general anesthesia with central sympatholytic effects, aids in stabilizing the patient’s hemodynamic status and possesses potent anesthetic and analgesic effects.[24,25,26] This leads to a reduction in the need for opioids and associated side effects,[26] as well as a decrease in stress response and improvement in recovery quality.[27] Dexmedetomidine’s unique anesthetic capability induces mild cognitive impairment, facilitating easy communication between the medical team and the patient in critical care units and cases requiring monitoring.[26]
Dexmedetomidine can be administered intravenously, intramuscularly, orally, buccally, and intranasally.[28] Its prescribed dose ranges from 0.3 to 2 µg/kg and may vary depending on the type of surgery and the patient’s age group. In our study, two doses of 0.5 and 1 µg/kg were used, with the 1 µg/kg dose providing better pain relief compared to the 0.5 µg/kg dose, with no significant difference in side effects. Therefore, based on the results of this study, the 1 µg/kg dose may be considered appropriate.
Indeed, due to the lower pain levels in both intervention groups, there was no need for additional analgesics, and the mean dose of additional analgesics received, along with the satisfaction of both the surgeon and the patient, was significantly higher in the DEX-0.5 and DEX-1 groups than the control group. However, the level of patient sedation did not significantly differ among the three groups. Additionally, differences in the occurrence of adverse events such as PONV, shivering, tachycardia, and bradycardia were not statistically significant due to their low frequency distribution among the three groups.
In line with this, the results of Liu et al.[29] also indicated that dexmedetomidine sedation could reduce postoperative delirium and be associated with shorter intubation times, although it might increase bradycardia in post-cardiac surgery patients compared to propofol. In our study, only one case of bradycardia was reported, and the incidence rate of adverse events was very minimal.
Moreover, the results of another study showed a significantly higher incidence of hypertension following intubation in the low-dose group, while dexmedetomidine at a dose of 1 µg/kg was not associated with hypotension or bradycardia.[21] Furthermore, the occurrence of nausea and other side effects, as well as the satisfaction of gynecologists with patient sedation, did not significantly differ between the dexmedetomidine and midazolam groups, but were significantly higher than the control group.[17]
It is essential to note that one of the crucial factors in patient satisfaction is pain control and sedation. In this study, due to successful pain control, less use of analgesics, and maintenance of patient sedation, the satisfaction level of both the patient and the surgeon was significantly higher in the intervention groups than the control group. Therefore, attention to these factors in assessing the satisfaction level of the surgeon and patient can be considered one of the strengths of this study. Additionally, the uniformity of anesthesia procedure and ovarian puncture protocol for all patients is another strength of this study. However, limitations such as the small sample size and the use of the same bolus and maintenance dose of dexmedetomidine in the DEX-1 and DEX-0.5 groups could be considered.
Given the effective pain control, sedation, and better hemodynamic stability of patients with dexmedetomidine, future studies are recommended to evaluate the effects of this drug at different doses and administration methods in various surgeries to select a safe and optimal dose based on the administration method and patient age groups.
CONCLUSION
According to the results of the present study, the administration of both doses of 0.5 and 1 µg/kg dexmedetomidine resulted in considerable hemodynamic stability. While pain control, need for additional analgesics, and patient and surgeon satisfaction were better with dexmedetomidine 1 µg/kg compared to dexmedetomidine 0.5 µg/kg, there were minimal differences in side effects in both groups. Therefore, in this surgical procedure (ovarian puncture), the administration of dexmedetomidine 1 µg/kg might be recommended due to better pain relief, higher satisfaction, and reduced need for additional analgesics and minimal occurrence of adverse events.
Ethics approval and consent to participate
This study with the ethics code of IR.MUI.MED.REC.1402.362 from Isfahan University of Medical Sciences and clinical trial code IRCT20200825048515N73 was conducted.
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
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