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The Role of Single Preoperative Oral Amisulpride on Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy: Prospective, Double-Blind, Randomized, Placebo-Controlled Trial Study

Authors: Devendra Gupta, Anubha Gupta, Rudrashish Haldar, Shashi Srivastava, Prabhakar K Mishra


Background: Occurrence of postoperative nausea and vomiting (PONV) still affects about 20–40% of surgical patients, with certain high-risk patients experiencing rates of up to 80% despite widespread use of prophylactic antiemetic agents. The antagonistic effect of Amisulpride, an antipsychotic drug, on dopamine receptors decreases the incidence of nausea and vomiting. Therefore, we hypothesized that a single preoperative oral dose of amisulpride would decrease the incident of PONV in patients undergoing craniotomy. Methods This single-center, prospective, double-blind, randomized, placebo-controlled study was conducted after approval from Institutional Ethical Committee and registration in the Clinical Trials Registry- India. Inclusion criteria was patients belong to ASA I-II, 18 to 60 years of either sex, scheduled for elective craniotomy requiring general anaesthesia. Patient with a history of drug or alcohol abuse, history of nausea or vomiting 24 hours before surgery, pregnant or lactating women, renal insufficiency, mental disorder or unconscious before the surgery, or planned for postoperative ventilation were excluded. Patients were randomly assigned into 2 groups of equal numbers using software- generated randomization table. Study group: Patients received a single oral tablet of Amisulpride 25 mg, and control group: Patients received a placebo (both given 2 hours prior to surgery). The sample size was calculated at a minimum two-sided 95% confidence interval and 80% power of the study, and thus minimum required sample size for each of the treatment and control group was 46. Anesthesia was similar in all case as per Institute protocol. At the end of the surgery, patients received I.V ondansetron 4 mg for PONV prophylaxis and I.V paracetamol 1000 mg for postoperative analgesia. Rescue antiemetic was in form of ondansetron 4 mg, and dexamethasone 4 mg intravenously was given postoperatively to any patient with PONV from which they requested relief. If PONV persisted, dexamethasone 4 mg intravenously was also administered. The primary outcome of the study was the incidence of nausea and/or vomiting 24 hour postoperatively. Secondary outcomes included severity of nausea, use of rescue medications, the severity of postoperative pain, requirement of analgesia, and incidences of adverse drug reaction within 24 hours postoperatively. Results: The demographics of the two groups were similar at baseline.PRIMARY OUTCOME: Number of the patients having “no episode” of nausea was higher in the amisulpride group (90%) as compared to the placebo group (40%) [95% CI- 32.1112% to 63.6199%, P < 0.001]. The NNT to benefit from this reduction was 2 patients [95% CI of 1.517 to 2.935]. Number of patients with “No episode” of vomiting was higher in the amisulpride group (94%) as compared to the placebo group (46%) [95% CI- 30.9888% to 61.6126%, P <0.001]. The NNT to benefit from this reduction was 2.083 patients [95% CI of 1.580 to 3.058].SECONDARY OUTCOME: The severity of nausea measured on NRS scale was significant lower in the amisulpride group (p<0.000). The requirement of rescue medication was much lower in the amisulpride group (10%) as compared to the placebo group (58%) [95% CI of 30.1514% to 61.8326%, p<0.001]. Postoperative pain and the use of analgesia were similar. Conclusion: We conclude based upon our prospective randomized controlled study that a single preoperative oral amisulpride 25mg decreases the incidence of PONV and severity of nausea in the patients undergoing craniotomy.

Keywords: postoperative nausea and vomiting, amisulpride, postoperative pain, postoperative analgesics

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