CTRI/2023/08/056860尚未招募3 期
Combination of haloperidol & ondansetron is non inferior to dexamethasone & ondansetron for prevention of post operative nausea and vomiting in patientsundergoing laparoscopic gynaecological procedures. A randomised double blinded trial.
Post Graduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2023年2月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Incidence of nausea using 11 point verbal numerical rating scale & number of episodes of vomiting
研究概览
简要总结
The study aims to compare two drug combinations for prophylaxis of post operative nausea and vomiting in patients undergoing laparoscopic gynaecological procedures.
Group DO: will receive 8mg dexamethasone after induction and 8mg ondansetron 30 minutes prior to extubation.
Group HO: will receive 1mg haloperidol after induction and 8mg ondansetron 30 minutes prior to extubation.
Primary outcome assessed will be the incidence of nausea and number of episodes of vomiting in the first 24 hours following the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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 physical status I/II Scheduled for laparoscopic procedures >1hr duration.
排除标准
- •History of hypersensitivity or allergic reaction to ondansetron or haloperidol
- •Established diagnosis or family history of congenital long QT syndrome
- •Parkinsons disease
- •Use of anti emetic within 24 hours of surgery
- •Use of antipsychotic drugs
- •Pregnant patients
- •Obese patients (BMI >30)
- •Electrolyte abnormalities
- •Haemodynamic instability in the peri operative period.
结局指标
主要结局
Incidence of nausea using 11 point verbal numerical rating scale & number of episodes of vomiting
时间窗: First 24 hours following laparoscopic gynaecological procedure
次要结局
- Requirement of rescue antiemetic(First 24 hours following laparoscopic gynaecological procedure, & name of drug administered)
- Post operative analgesia(First 24 hours following laparoscopic gynaecological procedure, using Visual Analog Score (VAS))
- Extent of sedation(First 24 hours following laparoscopic gynaecological procedure, using Observers assessment of alertness/sedation scale)
- Incidence of delirium using confusion assessment method (CAM)(First 24 hours following laparoscopic gynaecological procedure)
- Time to administration of rescue antiemetic(from end of procedure to occurrence of first episode of vomiting or sensation of nausea)
- corrected QT interval(within first hour following laparoscopic gynaecological procedure)
研究者
研究点 (1)
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