Comparing the efficacy of intravenous Amisulpride and Dexamethasone in preventing postoperative nausea and vomiting in high risk patients : A randomized controlled double blind study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Nausea and Vomiting (PONV) in 24 hrs of post operative period: In the ward, episodes of vomiting, retching will be recorded, and nausea score as per 11-point verbal rating scale from 0-10 with zero being no nausea and 10 being worst possible nausea and significant nausea defined as a score of 4 and above.
研究概览
简要总结
Comparing the Efficacy of Intravenous Amisulpride and Dexamethasone in Preventing Postoperative Nausea and Vomiting in High Risk Patients A Randomized Controlled Double Blind Study. Postoperative nausea and vomiting is a common and distressing complication following general anesthesia with an incidence up to 80 percent in high risk patients. It can delay recovery and hospital discharge. Risk factors include female gender, non smoking status, previous history of PONV or motion sickness, and perioperative opioid use. Dexamethasone is widely used as a prophylactic antiemetic but may cause hyperglycemia especially in diabetic patients. Amisulpride, a dopamine D2 and D3 receptor antagonist, has shown efficacy in preventing PONV in recent studies with minimal adverse effects. Comparative data between amisulpride and dexamethasone are limited in the Indian population. This study aims to compare their efficacy in preventing PONV among high risk surgical patients.This is a randomized double blind controlled trial conducted at AIIMS Rishikesh. A total of 324 adult patients aged 18 to 65 years, ASA physical status I or II, with an Apfel score of more than two, will be included. Patients will be randomly allocated into two groups. Group A will receive intravenous amisulpride 5 milligrams ten minutes before induction of anesthesia. Group D will receive intravenous dexamethasone 8 milligrams ten minutes before induction. Standardized anesthesia and analgesia protocols will be followed. Blinding will be maintained for patients and outcome assessor. The primary outcome is the incidence of postoperative nausea and vomiting within 24 hours after surgery. Secondary outcomes include severity of nausea, requirement for rescue antiemetic medication, duration of stay in post anesthesia care unit, and adverse effects related to amisulpride. This study will evaluate and compare the effectiveness and safety of intravenous amisulpride and dexamethasone for the prevention of postoperative nausea and vomiting in high risk patients undergoing general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Apfel criteria of more than
- •American society of anaesthesiologists (ASA) physical class I-II 3) Non-smoker.
排除标准
- •Patient refusal to participate in study 2) Any previous history of drug reaction to amisulpride 3) Patient with severe hepatic or renal dysfunction or cardiac dysfunction 4) Patient requiring orogastric /nasogastric tube in the post-operative period.
- •Patient with poorly controlled diabetes mellitus – HbA1c more than 9 6) Patient on medications which prolong QT interval.
- •Patient on other antipsychotic medications.
结局指标
主要结局
Incidence of Postoperative Nausea and Vomiting (PONV) in 24 hrs of post operative period: In the ward, episodes of vomiting, retching will be recorded, and nausea score as per 11-point verbal rating scale from 0-10 with zero being no nausea and 10 being worst possible nausea and significant nausea defined as a score of 4 and above.
时间窗: Above findings will be evaluated at 1st, 2nd, 6th, 12th and 24 hours of post-operative period
次要结局
- 1. Total dose of rescue anti emetic recorded in post operative period of 24 hours(2. Duration of PACU stay)
研究者
Dr Aryan Dimri
All India Institute of Medical Sciences,Rishikesh