Abstract
Background:
Nausea and vomiting (NV) seen during and after lower segment cesarean section (LSCS) are due to increased intragastric pressure, hypotension, stretching the peritoneum (exteriorization of the uterus), excessive surgical manipulation and visceral stimulation, using opioids, using uterotonic agents, and the patient's mental status. Ondansetron and granisetron intravenous (i.v.) are useful for avoiding bradycardia and hypotension.
Objectives:
The objective of this study is to study the effectiveness of granisetron versus ondansetron to control NV during LSCS under subarachnoid block.
Materials and Methods:
Eighty patients undergoing elective cesarean section under spinal anesthesia by intrathecal bupivacaine were randomly divided into two groups (40 pregnant females of the American Society of Anesthesiologists physical status Classes I and II in each Group). Group 1 received granisetron 40 mg.kg−1 i.v. stat after clamping the cord and Group 2 given i.v. ondansetron 8 mg stat after clamping the cord. NV were observed at the “early postoperative period (0–3 h)” and “late postoperative period (4–24 h).”
Statistical Analysis Used:
Student's t-test and Chi-square test were used to find out the statistical significance, P < 0.05 was considered statistically significant.
Results:
The mean age was 29.3 years with 4.15 standard deviation (SD) and 28.3 years with 4.41 SD in Groups 1 and 2, respectively. The mean duration of surgery was 53.1 min with 6.67 min SD and 57.7 min with 10.26 SD in Groups 1 and 2, respectively. In the “early postoperative period,” NV observed in 7.5% and 10.0% participants in Groups 1 and 2, respectively (P > 0.05), and in “late postoperative period,” NV observed in 0.0% and 22.5% participants in Groups 1 and 2, respectively (P < 0.05).
Conclusion:
Granisetron reduces the severity of spinal-induced hypotension, need for rescue vasopressor, and incidence of nausea.
Keywords: Granisetron, LSCS, nausea, ondansetron, spinal anesthesia, vomiting
INTRODUCTION
Nausea and vomiting (NV) are very common in different types of surgeries. However, issues are very commonly encountered during lower segment cesarean section (LSCS) operations under regional anesthesia.[1,2] The most common factors responsible for NV during and after LSCS are increased intragastric pressure, hypotension, stretching peritoneum (exteriorization of the uterus), excessive surgical manipulation and visceral stimulation, using opioids, using uterotonic agents, and the patient's mental status.[1,3,4,5]
Surgical techniques with peritonealization, exteriorizing the uterus for suturing, and peritoneal washing, may also play role in postoperative NV. Postoperative NV is seen in 80.0% of cases so preventive medication is very crucial in LSCS.[1]
Ondansetron and granisetron are selective 5-hydroxytryptamine 3 receptor antagonists, and thus may be useful for avoiding bradycardia and hypotension.[6] Ephedrine, an indirectly acting sympathomimetic amine, is probably the vasopressor of choice in obstetric anesthesia. Although ephedrine has mixed a-adrenoreceptor and b-adrenoreceptor activity, it maintains arterial pressure mainly by increases in cardiac output and heart rate as a result of its predominant activity on β1-adrenoceptors.[7] Hence, this study was conducted with the objective to study the effectiveness of granisetron versus ondansetron to control NV during LSCS under subarachnoid block.
MATERIALS AND METHODS
After obtaining approval from the Institutional Ethical Committee (IEC) (IRB no. BMCRI/IEC(H)/Approval/A1-/2021/12/22/26), dated December 22, 2021, and informed consent from all parturient, this comparative study was conducted in anesthesia department of one of the medical colleges of Gujarat from December 2021 to March 2022. All cases included were of the American Society of Anesthesiologists (ASA) physical status (PS) Classes I or II, aged 20–40 years, and undergoing an elective cesarean section. A total of 110 such patients were registered during the study. Cases with contraindications to subarachnoid block, who refused to participate, who had a history of hypersensitivity to the studied drugs, who had hypertensive disorders of pregnancy, and those receiving selective serotonin reuptake inhibitors or migraine medications were excluded from the study. Considering exclusion criteria, around 80 patients were found to be eligible for the study, and all of them were included in the study after taking informed consent.
Cases were randomly allocated into two equal groups of 40 patients each using a computer-generated randomization chart. Group 1 patients received intravenous (i.v.) granisetron 40 μg.kg−1 stat after clamping the cord. Group 2 patients received ondansetron 8 mg i.v. stat after clamping the cord.
Anesthetic technique
The anesthesia technique was standardized for all the patients. Patients were given tablet alprazolam 0.25 mg the night before surgery and kept nil oral for 8 h. All patients were inserted 18G cannula on arrival in the preoperative room and patients were preloaded with 15 mL.kg−1 Ringer's lactate solution over 20 min after preloading, the patient was shifted to the operation theater where standard monitoring was applied including noninvasive arterial blood pressure, pulse, oximeter, and electrocardiogram.
In both groups, the study solution was transfused 5 min before the institution of spinal anesthesia. The lumber puncture for spinal anesthesia was performed with patients in the sitting position at L3–L4 space with 25G Quincke's needle by midline approach with full aseptic precautions. After confirmation of cerebrospinal fluid through the needle, 3.5 mL of 0.5% hyperbaric bupivacaine was injected. The patient was immediately placed in supine position on the operation table without any tilt. Time at the completion of intrathecal injection was noted as zero time.
The study observed for “early postoperative period (0–3 h)” NV and “late postoperative period (4–24 h)” NV as well as any other adverse effects. The data were recorded in an Excel sheet and descriptive analysis was performed, of which data are presented in the tables.
RESULTS
Table 1 shows that the mean age was 29.3 years with 4.15 standard deviation (SD) and 28.3 years with 4.41 SD in Groups 1 and 2, respectively. The difference between the mean age of both groups was statistically not significant (P > 0.05). According to the ASA classification, 15.0% and 85.0% of participants of Group 1 belonged to ASA PS Classes I and II, respectively. Around 20.0% and 80.0% of participants of Group 2 belonged to ASA PS Classes I and II, respectively. The difference between these two groups according to the ASA classification was statistically not significant (P > 0.05). The mean duration of surgery was 53.1 min with 6.67 SD and 57.7 min with 10.26 SD in Groups 1 and 2, respectively. The difference between the mean duration of surgery in both groups was statistically significant (P < 0.05).
Table 1.
Socioclinical variables of the study participants (n=80)
| Variables | Group 1 (n=40) | Group 2 (n=40) | P |
|---|---|---|---|
| Age (years), mean±SD | 29.3±4.15 | 28.3±4.41 | 0.312* |
| ASA classification, n (%) | |||
| I | 6 (15.0) | 8 (20.0) | 0.76** |
| II | 34 (85.0) | 32 (80.0) | |
| Surgery duration (min), mean±SD | 53.1±6.67 | 57.7±10.26 | 0.02* |
*Student t-test, **Chi-square test. SD=Standard deviation, ASA=American Society of Anesthesiologists
Table 2 shows that in the “early postoperative period,” NV observed in 7.5% and 10.0% of participants in Groups 1 and 2, respectively, and not observed in 92.5% and 90.0% of participants, respectively. The difference was statistically not significant (P > 0.05). In the “late postoperative period,” NV observed in 0.0% and 22.5% of participants in Groups 1 and 2, respectively, and not observed in 100.0% and 77.5% of participants, respectively. The difference was statistically significant (P < 0.05).
Table 2.
Nausea and vomiting status of the study participants (n=80)
| NV | Group 1 (n=40), n (%) | Group 2 (n=40), n (%) | P* |
|---|---|---|---|
| Early postoperative period | |||
| Present | 3 (7.5) | 4 (10.0) | 1.0 |
| Absent | 37 (92.5) | 36 (90.0) | |
| Late postoperative period | |||
| Present | 0 | 9 (22.5) | 0.004 |
| xAbsent | 40 (100.0) | 31 (77.5) |
*Chisqaure test (with Yate’s correction is applied to test the significance. P value <0.05 is considered as significant). NV=Nausea and vomiting
DISCUSSION
NV during regional anesthesia for cesarean section are very routine and undesirable episodes resulting in significant distress to the patient and also disturbing the surgeries.[8]
The present study found the mean age of Group 1 (granisetron) was slightly higher than Group 2 (ondansetron) but statistically not significant. Postoperative NV is noted fewer in number with advanced maternal age, which is responsible for decreasing the level of estrogen levels. NV are seen in four times more in women compared to male in nonobstetrical surgeries.[2,9] This NV incidence event decreases with menopause, but still remains higher than that in men, which attribute a major part of sex hormones in NV.[10,11,12] This finding is correlate with Rasooli et al.,[13] Kumar et al.,[14] Khalifa et al.,[15] and Rashad et al.[16]
Surgery duration was significantly higher in the ondansetron group than in the granisetron group. The study was done by Rashad et al.[16] observed similar surgery duration on both groups.
A higher incidence of NV was observed in the ondansetron group than in the granisetron group in the early postoperative period. Almost 2/5th of cases, NV were observed in Group 2. During the late postoperative period, not a single case of NV was observed in Group 1. Cases on NV were significantly higher in Group 2.
High level of progesterone and intra-abdominal pressures are also responsible for the NV in pregnant women. Multimode antiemetic prophylaxis has a preventive effect against NV cases who underwent for spinal anesthesia.[17,18] This finding is correlate with the similar study done by Rashad et al.,[16] Mowafi et al.,[19] Fassoulaki et al.,[20] and Soltani-Mohammadi et al.[21] but not correlate with the similar study done by Kumar et al.[14] and Khalifa et al.[15]
CONCLUSION
The use of 40 mg granisetron during LSCS is more effective to control the incidence of early and late postoperative NV compare to 8 mg i.v. ondansetron. Granisetron reduces the severity of spinal-induced hypotension, need for rescue vasopressor, and incidence of nausea.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest
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