SINGLE CENTRE, DOUBLE BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO EVALUATE EFFECTIVENESS OF AMISULPRIDE TO PREVENT POST OPERATIVE NAUSEA AND VOMITING IN FEMALE PATIENTS UNDERGOING BREAST SURGERY
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- To compare the incidence of emesis in 24 hours.
研究概览
简要总结
The incidence of PONV in female patients undergoing breast cancer surgery is reported as 30%-68% even when patients have been administered intraoperative prophylactic antiemetics. Amisulpride is a dopamine receptor antagonist; D2 and D3. At low doses, amisulpride blocks presynaptic receptors, which facilitates dopamine release and thus resolves dopaminergic hypoactivity which prevents PONV. Efficacy in preventing PONV by prophylactic administration of a combination of amisulpride and ondansetron has not been studied in this setting. so, we hypothesized that prophylactic administration of a single-dose combination of amisulpride and ondansetron intraoperatively would decrease the incidence of PONV in female patients undergoing breast surgery.
Incidence of PONV in female patients undergoing breast cancer surgery is reported as 30%-68% even when patients have been administered intraoperative prophylactic antiemetics, Amisulpride is a dopamine receptor antagonist; D2-D3. at low doses, amisulpride blocks presynaptic receptors, which facilitates dopamine release and thus resolves dopaminergic hypoactivity which prevents PONV. Efficacy in preventing PONV by prophylactic administration of a combination of amisulpride and ondansetron has not been studied in the setting. so, we hypothesized that prophylactic administration of a combination of amisulpride and ondansetron intraoperatively would decrease the incidence of POBNV in female patients undergoing breast surgery.
Reference:
1. Kang C, Shirley M. Amisulpride: A Review in Post-Operative Nausea and Vomiting. Drugs. 2021; 81:367-375.
2. Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS et al. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020; 131:411-448
3. Couture DJ, Maye JP, O’brien D, Beldia Smith A. Therapeutic modalities for the prophylactic management of postoperative nausea and vomiting. J Perianesth Nurs. 2006; 21:398-403
4. Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: a simple yet complex problem. Anesth Essays Res. 2016; 10:388–96.
5. Cao X, White PF, Ma H. An update on the management of postoperative nausea and vomiting. J Anesth. 2017; 31:617-626.
6. Tateosian VS, Champagne K, Gan TJ. What is new in the battle against postoperative nausea and vomiting. Best Pract Res Clin Anaesthesiol. 2018; 32:137-148.
7. Naylor RJ, Rudd JA. Pharmacology of ondansetron. Eur J Anaesthesiol Suppl. 1992; 6:3-10.
8. Layeeque R, Siegel E, Kass R, Henry-Tillman RS, Colvert M, Mancino A, et al. Prevention of nausea and vomiting following breast surgery. Am J Surg. 2006; 191:767–72.
9. Matchock RL, Levine ME, Gianaros PJ, Stern RM. Susceptibility to nausea and motion sickness as a function of the menstrual cycle. Women’s Health Issues*.* 2008; 18:328–35
10. Piechotta V, Adams A, Haque M, Scheckel B, Kreuzberger N, Monsef I. Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis. Cochrane Database Syst Rev. 2021; 16;11:CD012775.
11 Fox G, Kranke P. A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting. Expert Rev Clin Pharmacol. 2020; 13:331–40.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •ASA-I,ASA-II and ASA-III UNDERGOING BREAST SURGERY.
排除标准
- •History of hypersensitivity or allergic reaction to Amisulpride/ondansetron.
- •Hypokalemia (less than 3.0 mmol/L).
- •Prolactin-dependent tumor/pheochromocytoma.
- •Cardiac dysrhythmias Congenital long QT Pregnant female The patient is on steroids preoperatively.
结局指标
主要结局
To compare the incidence of emesis in 24 hours.
时间窗: 24 hours
次要结局
- Incidence of nausea.(Use of rescue medication in the first 24 hours post-operatively.)
研究者
Dr Jitendra Kumar Thakur
PGIMER Chandigarh
