Abstract
Background
Daytime hysteroscopy requires anesthesia that offers rapid onset and clearance, with minimal respiratory and cardiovascular suppression. This study compared the effects of different doses of alfentanil combined with propofol target-controlled infusion (TCI) for such procedures.
Methods
We randomized 240 patients undergoing daytime hysteroscopy into three groups to receive alfentanil at doses of 5 μg/kg, 10 μg/kg, and 15 μg/kg, combined with propofol TCI. We meticulously recorded complications and perioperative vitals to evaluate the safety and efficacy of each dosage regimen.
Results
The 10 μg/kg dose of alfentanil, used in conjunction with propofol, required lower propofol dosages and resulted in quicker recovery time and fewer intraoperative movements. However, higher doses of 15 μg/kg led to a significant increase in hypoxemia and instability in hemodynamics and oxygenation.
Conclusion
Combining alfentanil at 10 μg/kg with propofol TCI for daytime hysteroscopy results in high effectiveness. A lower incidence of complications, a reduced propofol requirement, and rapid emergence from sedation characterize this regimen.
Keywords: Alfentanil, Intravenous anesthesia, Hysteroscopy, Analgesia, Drug evaluation
Graphical abstract
1. Background
Daytime surgery has recently gained rapid domestic and international recognition due to its convenience, efficiency, and cost-effectiveness [1]. Ideal anesthetic agents for these procedures should have a rapid onset and clearance, provide adequate analgesia and sedation, and minimize cardiovascular and respiratory impacts without causing severe adverse reactions [2]. Hysteroscopy, a minimally invasive technique noted for its safety and minimal tissue trauma, is particularly well-suited to daytime operations [3]. Propofol is frequently used due to its quick onset and recovery; however, it has no analgesic effect and can cause respiratory and circulatory depression [4].
To mitigate these risks, propofol is often combined with opioid analgesics such as alfentanil—a potent, short-acting opioid ideal for perioperative analgesia in such settings [5,6]. Despite the benefits, the combination of propofol and alfentanil for hysteroscopic surgery remains underexplored [7]. Furthermore, alfentanil has a relatively short time on the market in China, and our trial may be one of the first studies to explore its safety and appropriate dosage for this population of Asians in hysteroscopic surgery. This study investigates the clinical impacts of various alfentanil doses when used with propofol TCI in daytime hysteroscopic surgery, aiming to establish evidence-based recommendations for this anesthesia protocol. The study has a relatively large sample size, with observations extending until the time of discharge.
2. Materials and methods
2.1. Ethical clearance
This randomized controlled trial received approval from the Hospital Ethics Committee and was registered with the Chinese Clinical Trial Registry (https://www.chictr.org.cn/showproj.html?proj = 177784; Registration No: ChiCTR2200063939). Informed consent was obtained from all patients, and the study protocol strictly adhered to the principles of the Helsinki Declaration.
2.2. Sample size calculation
We estimated the occurrence of intraoperative hypoxemia as the primary outcome. Based on preliminary results, we anticipated 10 % and 30 % incidence rates for the 5 μg/kg and 15 μg/kg alfentanil doses, respectively. We set a significance level (alpha) of 0.05 and a power of 85 %. Using Power Analysis and Sample Size (PASS) software, version 2024 (NCSS, LLC, Kaysville, USA), we calculated a sample size of 71 for each group. Factoring in a 10 % dropout rate, we required at least 80 patients per group, totaling at least 240 participants.
2.3. Participant selection
Participants were selected for this study if they underwent daytime hysteroscopy between October 2022 and May 2023. Inclusion criteria were patients aged 18–60, with a BMI of 18–28 kg/m2, and classified as ASA I or II. Exclusion criteria included allergies to propofol or opioid drugs, a history of alcohol or substance dependence, a history of obstructive sleep apnea syndrome (OSAS), and a prior history of postoperative nausea and vomiting (PONV) or syncope. Exclusion criteria also covered cases requiring endotracheal intubation due to an expanded surgical scope or patient withdrawal from the experiment upon request. From October 2022 to May 2023, 240 patients undergoing daytime hysteroscopic surgery were recruited from the Chongqing Health Center for Women and Children (Women and Children's Hospital of Chongqing Medical University).
2.4. Randomisation, allocation, and concealment
We used a computer-generated list for random assignment into three groups, maintaining allocation concealment with sealed opaque envelopes only opened upon the patient's arrival in the surgery room. Independent researchers prepared the medication and were blind to treatment assignment and outcome assessment.
2.5. Study outcomes
The primary outcome of this study was intraoperative hypoxemia. The secondary outcomes involved perioperative complications, hemodynamic indicators, pain scores, and propofol dosage.
2.6. Study protocol
This trial employed a standardized anesthesia protocol. Patients were instructed to fast from solid food for 8 h and clear liquids for 2 h before the procedure, with no preoperative medication. Upon admission, patients assumed the lithotomy position and intravenous access was established. Oxygen supplementation (5 L/min) via a face mask was initiated. Continuous cardiac monitoring included electrocardiography, non-invasive blood pressure (NIBP), heart rate (HR), and oxygen saturation (SpO2). Patients were randomly assigned to one of three groups (Group A1, A2, or A3).
Propofol (AstraZeneca UK Limited, batch number: H20130504) was administered via a TCI pump (Beijing Slgo Medical Technology Co., Ltd., model: CP-730TCI), targeting a plasma concentration of 2.5 μg/ml. Upon loss of consciousness, patients received an intravenous dose of alfentanil (China Eno Pharmaceutical, batch no. H20213853): 5 μg/kg for Group A1, 10 μg/kg for Group A2, and 15 μg/kg for Group A3. The alfentanil was diluted to 10 ml and administered slowly over 30 s.
In the case of intraoperative body movement, a single intravenous injection of 20–30 mg propofol was administered. If hypotension occurred, ephedrine hydrochloride (Chengdu Betta Pharmaceutical Co., Ltd., batch number: H32021530) 3–6 mg was administered intravenously. Bradycardia was addressed with intravenous atropine sulfate (Southwest Pharmaceutical Co., Ltd., batch number: H50020044) 0.2–0.5 mg. For tongue obstruction, a pharyngeal airway was inserted. If hypoxemia occurred, pressurized mask ventilation was applied until recovery.
Postoperatively, pain was assessed using the Numeric Rating Scale (NRS) (with 0 indicating ‘no pain’ and 10 indicating ‘worst pain imaginable’) [8]. If the score exceeded 3 points, additional analgesic treatment with 40 mg parecoxib (Qilu Pharmaceutical Co., Ltd., batch number: H20183180) was administered (Graphical Abstract).
2.7. Data collection
The collected data included demographic information, and hemodynamic indicators at specific time points: before anesthesia induction (T0), at the commencement of surgery (T1), 5 min after the start of surgery (T2), at the end of surgery (T3), and upon admission to the Post-Anesthesia Care Unit (PACU) (T4). Surgical data recorded comprised duration of surgery and patient satisfaction. Anesthesia-related data included the dosage of propofol, awakening time (measured from the cessation of propofol to the moment the patient could respond by name), and postoperative pain assessed using the NRS in the PACU and 2 h following surgery. Complications included intraoperative body movements, hypoxemia (oxygen saturation below 92 % under oxygen supplementation), bradycardia (heart rate below 50 bpm), hypotension/hypertension (a decrease/increase in SBP more significant than 30 % compared to pre-anesthesia levels), PONV grading 2 h postoperatively (Grade I - no nausea, Grade II - mild nausea, mild abdominal discomfort, no vomiting, Grade III - evident nausea and vomiting, but no material expelled, Grade IV - severe vomiting, expulsion of gastric contents necessitating medication), dizziness 2 h postoperatively, skin itching, and postoperative delirium.
2.8. Statistical analysis
Statistical analysis was performed using the Statistical Package for Social Science (SPSS) for Windows, version 27.0 (SPSS Inc., Chicago, IL, USA). Normality was assessed using the Shapiro-Wilk test. Quantitative data with a normal distribution were presented as mean ± standard deviation (SD) and compared using the one-way ANOVA test between the three groups and LSD or Tamhane's T2 test for post hoc multiple comparisons. Quantitative data with an abnormal distribution were presented as median (inter-quartile range) and compared using the Kruskal-Wallis H test among the three groups and for the post hoc multiple comparisons. Because most vital values presented an abnormal distribution, repeated-measures generalized estimating equations (GEE) were employed to assess group and time effects and the interaction effect of SBP, DBP, HR, and SpO2 values. Additionally, the Friedman and Kruskal-Wallis H test were used to assess differences in these values at various time points within each group and among the three groups at each time point. Categorical data are presented as numbers and percentages, and data sets were compared using the Pearson chi-squared and Fisher's exact tests. The Kruskal-Wallis H test was used to compare ranked data: satisfaction evaluation scores, NRS scores for pain, PONV grading, and the ASA physical condition. Statistical significance was set at a two-tailed P-value of <0.05 (significance values of group effects were adjusted by Bonferroni correction).
3. Results
3.1. Enrollment and participation
Out of the 240 patients initially enrolled, the final analysis included 236 participants. One patient withdrew due to the need for unexpected laparoscopic expansion requiring endotracheal intubation, and another withdrew due to refusal to continue with the protocol. Two additional cases were lost to follow-up. The analyzed groups comprised Group A1, 79 patients; Group A2, 78; and Group A3 also with 79 (Fig. 1).
Fig. 1.
Flow chart of the study.
3.2. Preoperative assessment
Across the three groups, no statistically significant differences were observed in age, weight, height, ASA Physical Status, or diagnosis. Baseline hemodynamic measurements were also similar (Table 1).
Table 1.
Demographics and baseline values.
| Group A1 (n = 79) |
Group A2 (n = 78) |
Group A3 (n = 79) |
P - value |
|
|---|---|---|---|---|
| Age, years | 41.41 ± 8.86 | 42.40 ± 10.83 | 40.67 ± 8.71 | 0.520 |
| Weight, kg | 58.08 ± 10.65 | 58.00 [50.00 to 65.00] | 56.00 [50.00 to 66.00] | 0.922 |
| Height, cm | 157.92 ± 5.23 | 158.00 [155.00 to 160.00] | 159.00 [153.00 to 163.00] | 0.175 |
| ASA (Ⅰ/Ⅱ) | 64/15 | 68/10 | 62/17 | 0.344 |
|
Diagnosis Endometrial polyps Intrauterine adhesion Uterine malformation Submucous myoma Contraceptive ring incarceration Abnormal uterine bleeding |
38 (48.1 %) 12 (15.2 %) 4 (5.1 %) 4 (5.1 %) 5 (6.3 %) 16 (20.3 %) |
45 (57.7 %) 13 (16.7 %) 2 (2.6 %) 2 (2.6 %) 4 (5.1 %) 12 (11.8 %) |
46 (58.2 %) 11 (13.9 %) 2 (2.5 %) 4 (5.1 %) 4 (5.1 %) 12 (15.2 %) |
0.956 |
| SBP prior to anesthesia induction, mmHg | 124.00 [113.00 to 141.00] | 126.00 [118.00 to 138.00] | 128.00 [116.00 to 141.00] | 0.798 |
| DBP prior to anesthesia induction, mmHg | 78.00 [70.00 to 87.00] | 76.00 [69.00 to 82.00] | 79.00 [72.00 to 87.00] | 0.217 |
| HR prior to anesthesia induction, beats/min | 74.37 ± 8.67 | 75.00 [70.00 to 82.00] | 77.14 ± 9.06 | 0.152 |
| SpO2prior to anesthesia induction, % | 98.00 [97.00 to 99.00] | 98.00 [98.00 to 99.00] | 99.00 [97.00 to 99.00] | 0.317 |
| NRS for pain before surgery, score | 0.00 [0.00 to 0.00] | 0.00 [0.00 to 0.00] | 0.00 [0.00 to 0.00] | 0.604 |
Data are presented as mean ± SD, median (inter-quartile range) or numbers (percentage).
There were no significant differences between the two groups for all variables.
ASA = American Society of Anesthesiologists; SBP = systolic blood pressure; DBP = diastolic blood pressure; HR = heart rate; NRS = numerical rating scale.
3.3. Primary outcomes
Group A3 exhibited a notably higher incidence of intraoperative hypoxemia than Groups A1 and A2. Specifically, the incidences were 6.3 % (5 cases) in Group A1, 3.8 % (3 cases) in Group A2, and 21.5 % (17 cases) in Group A3, with statistical significance (P < 0.001; A3 vs. A1, P = 0.006; A3 vs. A2, P < 0.001) (Table 2).
Table 2.
Adverse outcomes.
| Group A1 (n = 79) |
Group A2 (n = 78) |
Group A3 (n = 79) |
P - value |
|
|---|---|---|---|---|
| Hyoxemia | 5 (6.3 %) | 3 (3.8 %) | 17 (21.5 %)bc | <0.001 |
| Intraoperative body movement, n(%) | 29 (36.7 %) | 11 (14.1 %)a | 9 (11.4 %)b | <0.001 |
| Bradycardia | 13 (16.5 %) | 10 (12.8 %) | 8 (10.1 %) | 0.497 |
| Hypotension | 7 (8.9 %) | 7 (9.0 %) | 10 (12.7 %) | 0.668 |
| Additional analgesia | 15 (19.0 %) | 8 (10.3 %) | 6 (7.6 %) | 0.074 |
| PONV(Ⅰ/Ⅱ/Ⅲ/Ⅳ) | 73/5/1/0 | 73/3/2/0 | 74/5/0/0 | 0.757 |
| Dizziness | 1 (1.3 %) | 3 (3.8 %) | 2 (2.5 %) | 0.538 |
| Pruritus | 0 (0 %) | 0 (0 %) | 0 (0 %) | / |
| Delirium | 0 (0 %) | 0 (0 %) | 0 (0 %) | / |
Data are presented as the mean ± SD, median (inter-quartile range) or numbers (percentages).c Group A3 vs. group A2, the difference is statistically significant (P < 0.05).
Abbreviations: PONV = postoperative nausea and vomiting.
Group A2 vs. group A1, the difference is statistically significant (P < 0.05).
Group A3 vs. group A1, the difference is statistically significant (P < 0.05).
3.4. Secondary outcomes
There were no statistically significant differences in the incidence of bradycardia, hypotension, additional analgesia, PONV, dizziness, pruritus, or delirium among the three groups. However, Group A1 displayed a significantly higher incidence of intraoperative body movements (Table 2).
Regarding anesthesia specifics, there were no significant differences across the groups in surgery duration, patient satisfaction, or 2-h postoperative NRS pain scores. Notably, NRS scores in the PACU were higher in Group A1 compared to Group A2. Group A1 also had a higher total propofol dose and a longer awakening time than the other groups (Table 3).
Table 3.
Anesthesia data.
| Group A1 (n = 79) |
Group A2 (n = 78) |
Group A3 (n = 79) |
P- value |
|
|---|---|---|---|---|
| Total propofol dosage, mg | 244.66 ± 59.46 | 195.00 [160.00 to 260.00]a | 180.90 [139.37 to 250,40]b | <0.001 |
| Time to awakening, min | 7.51 ± 0.84 | 6.00 [5.00 to 7.00]a | 6.79 [5.26 to 7.83]b | <0.001 |
| Duration of surgery, min | 12.51 ± 4.82 | 12.50 [8.75 to 16.50] | 11.46 [8.87 to 16.09] | 0.419 |
| Satisfaction evaluation of patients, score | 9.00 [9.00 to 10.00] | 9.50 [9.00 to 10.00] | 9.04 [9.02 to 9.04] | 0.368 |
| NRS for pain in PACU, score | 3.14 ± 1.05 | 3.00 [2.00 to 3.00]a | 3.00 [2.70 to 3.00] | 0.044 |
| NRS for pain 2-h after surgery, score | 1.46 [0.98 ± 1.95] | 2.00 [1.00 to 2.00] | 1.21 [1.00 ± 1.99] | 0.100 |
Data are presented as the mean ± SD, median (inter-quartile range) or numbers (percentages).cGroup A3 vs. group A2, the difference is statistically significant (P < 0.05).
Abbreviations: NRS = numerical rating scale; PACU = post-anesthesia care unit.
Group A2 vs. group A1, the difference is statistically significant (P < 0.05).
Group A3 vs. group A1, the difference is statistically significant (P < 0.05).
All groups showed a significant reduction in NIBP and HR at the onset of surgery (T1) compared to baseline (T0) (Fig. 2a, b, 2c). Groups A1 and A2 returned to baseline NIBP levels by the end of the surgery (T3) or upon PACU admission (T4). In contrast, Group A3 did not return to preoperative SBP levels until PACU admission (T4) (Fig. 2a and b) and displayed lower SBP levels at 5 min post-surgery onset (T2) and at PACU admission (T4) compared to the other groups (Fig. 2a). Additionally, SpO2 levels in Group A3 were significantly lower than those in the other groups at T1 and T2 (Fig. 2d), indicating less stability in blood pressure and oxygenation.
Fig. 2.
Changes in hemodynamic parameters. (a) Changes in SBP during repeated measuring. (b) Changes in DBP during repeated measuring. (c) Changes in HR during repeated measuring. (d) Changes in SpO2 during repeated measuring. a Group A2 vs. group A1, the difference is statistically significant (P < 0.05). b Group A3 vs. group A1, the difference is statistically significant (P < 0.05). c Group A3 vs. group A2, the difference is statistically significant (P < 0.05). Time points are T0 (before anesthesia induction); T1 (at the commencement of surgery); T2 (5 min after surgery started); T3 (at the end of surgery), and T4 (in PACU). Abbreviations: SBP = systolic blood pressure. DBP = diastolic blood pressure; HR = heart rate. PACU = post-anesthesia care unit.
4. Discussion
This study assesses the efficacy of various doses of alfentanil combined with propofol TCI during daytime hysteroscopic surgery. It evaluates analgesic effects, hemodynamic changes, and adverse event frequencies to determine the more suitable alfentanil dosage. Our findings suggest that 10 μg/kg of alfentanil minimizes propofol usage, reduces awakening time, enhances analgesic effectiveness, and significantly decreases intraoperative body movements and hypoxemia, indicating it may be more appropriate than the other two doses for such procedures.
Hysteroscopic procedures are indispensable in the diagnosis and treatment of intrauterine conditions. While daytime hysteroscopic surgery is relatively straightforward, it remains invasive and has been reported to cause severe pain, which is not fully recognized [9]. Although some studies suggest interventions without anesthesia for hysteroscopic surgery [10], the prevailing viewpoint emphasizes the crucial role of effective pain management in alleviating the pain associated with intrauterine procedures [11]. The combination of total intravenous anesthesia (TIVA) with propofol and short-acting opioids is commonly utilized for short and daytime surgical procedures involving spontaneous ventilation [12,13]. In our hospital, a well-balanced anesthetic protocol has been implemented for daytime hysteroscopic surgery to improve patient comfort and mitigate the risk of adverse events.
Typically, PONV affects 20–30 % of patients post-general anesthesia [14], with up to 37 % of daytime surgery patients experiencing symptoms post-discharge [15]. Our study's the incidence was only 6.78 % (16 cases), below the rates reported in previous studies. Propofol exhibits antiemetic effects [16], and both alfentanil and propofol are rapidly metabolized drugs with a similar half-life of fast distribution (T½α). The rapid metabolism and antiemetic properties likely contributed to this reduced incidence.
Group A3 experienced lower oxygen saturation than other groups and higher hypoxemia-related adverse reactions attributable to high alfentanil dosing [17,18]. High doses also caused significant hemodynamic instability, including marked reductions in SBP due to decreased vascular resistance or cardiac output, influenced by alfentanil's effects on venous and arterial vasodilation, baroreflex suppression, and myocardial contractility [19].
Group A1 showed more intraoperative body movement, possibly due to insufficient alfentanil for effective pain suppression [20]. Intraoperative body movement not only affects the surgeon's performance but also increases the risk of uterine injury. Insufficient analgesia also resulted in higher propofol needs and prolonged awakening times [21].
No severe complications occurred in this study, which confirms that alfentanil, when used with propofol under rigorous monitoring, is safe and effective for daytime hysteroscopy. This procedure requires drugs that act quickly, metabolize rapidly, and minimally depress respiratory and circulatory systems. The dose of 10 μg/kg of alfentanil was associated with fewer adverse reactions and stable hemodynamics than five or 15 μg/kg [22].
Chenyang Xu et al. utilized the Modified Dixon sequential method to determine the effective dose of alfentanil for daytime hysteroscopy: the ED50 and ED95 were 5.701 μg/kg and 8.817 μg/kg [7]. However, their study focused on shorter diagnostic procedures without therapeutic interventions. The primary focus was on body movement during cervical dilation and hysteroscope placement, with a relatively small sample size. In contrast, our study covered therapeutic interventions with extended durations, highlighting the need for potentially higher alfentanil doses due to increased procedural pain.
Although 3–7 μg/kg of alfentanil can achieve good analgesic effects with low complication rates in painless gastrointestinal endoscopy, this lower dosage is limited to short outpatient procedures [[23], [24], [25]]. Additionally, some studies have used 20 μg/kg of alfentanil combined with remimazolam for hysteroscopy, but the incidence of hypoxemia at this dosage is relatively high, at 21.6 % [26]. Zhu Hongyu et al. [27]found that combining 10 μg/kg alfentanil and 0.2 mg/kg remimazolam also provides suitable sedation and analgesia for painless hysteroscopic procedures. Compared to 1 μg/kg and 5 μg/kg, 10 μg/kg of alfentanil in painless abortion procedures reduces the amount of propofol required and decreases intraoperative body movements, thereby shortening the onset time of propofol and the time to awakening [28]. Therefore, 10 μg/kg of alfentanil might be appropriate for short gynecological procedures.
Our study has some limitations. First, some studies have shown that BIS monitoring helps reduce propofol dosage and increases endoscopists’ satisfaction [29,30]. In our study, the level of sedation was not monitored; if BIS monitoring were used, it would provide more precise guidance on the depth of sedation. Additionally, the study is single-center, which may limit the generalizability of the findings, suggesting that further research across multiple centers would provide more definitive results. Finally, the data collection was extended until discharge, and some adverse effects, such as PONV, persisted or emerged after discharge [15]. The lack of post-discharge follow-up might result in a missed opportunity to observe the long-term effects of the anesthesia protocol.
5. Conclusion
Our findings indicate that 10 μg/kg of alfentanil with propofol is associated with reduced propofol use, faster recovery, and fewer complications compared to doses of 5 or 15 μg/kg, suggesting it is a potentially more effective and safe dosage for analgesia.
Ethics approval and consent to participate
The study has received ethical approval from the Medical Ethics Committee of Chongqing Health Center for Women and Children (Registration number: 2022-060) and was duly registered with the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number: ChiCTR2200063939). The date of first registration was 21/09/2022. All protocols were carried out strictly with the relevant guidelines and regulations. Written informed consents were obtained from all participating patients.
Consent for publication
The patients gave written informed consent for publication in this study. Copies of the written consent form are available for review by the editor of this journal.
Data availability statement
Data will be made available on request.
Funding
The Beijing Health Alliance Charitable Foundation supported this study: NO. KM-20230601-01. The funders had no role in study design, data collection and analysis, publication decisions, or manuscript preparation.
CRediT authorship contribution statement
Sisi Deng: Writing – original draft, Data curation, Conceptualization. Xuezhu Huang: Writing – review & editing, Writing – original draft, Conceptualization. Xiaofeng Lei: Data curation.
Declaration of generative AI and AI-assisted technologies in the writing process
The authors declare that they did not use AI or AI technologies in writing.
Declaration of competing interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Acknowledgements
None.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data will be made available on request.