跳至主要内容
临床试验/CTRI/2023/04/051958
CTRI/2023/04/051958尚未招募不适用

A randomized comparative control study on effects of dexmedetomidine versus dexamethasone on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic surgery under general anaesthesia.

Suchana Maji1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年8月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
To evaluate and compare complete response to and/or incidence of Post operative nausea and vomiting with dexmedetomidine and dexamethasone seperately.

研究概览

简要总结

This study is a randomized,double blinded, parallel group, single centre trial evaluating and comparing the efficacy of intravenous dexmethasone and intravenous dexmedetomidine on incidence of post opearative nausea and vomiting in patients undergoing laproscopic surgeries under general anaesthesia. the primary outcome will be to evaluate and compare complete response to and/or incidence of Post operative nausea and vomiting with dexmedetomidine and dexamethasone seperately. secondary outcomes will be to compare and evaluate incidence of rescue antiemetic used with dexmedetomidine and dexamethasone,to compare and evaluate side effects of dexmedetomidine and dexamethasone,to compare and evaluate patient satisfaction with Post-opeartive Nausea and vomiting.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Patients of ASA physical status I and II, both gender in the mentioned age group who will give written informed consent.

排除标准

  • •Patients with ASA physical status III of greater.
  • •Severe cardiorespiratory,hepatic,renal,neurological or endocrinal disease.
  • •Bradycardia(Heart Rate<60bpm).
  • •Pregnant and lactating women.
  • •Obesity(BMI>30kg/m2).
  • •Diabetes mellitus.
  • •Patientswith known hypersensivity of drug allergies.
  • •Patients who had taken H2 antagonists,antiemetic or psychoactive medication.
  • •Nausea, retching,or vomiting within 48hours before surgery.
  • •History of Motion sickness.
  • •Patients who refuse to participate in the study.

结局指标

主要结局

To evaluate and compare complete response to and/or incidence of Post operative nausea and vomiting with dexmedetomidine and dexamethasone seperately.

时间窗: Baseline | Before Administration Of Drug | After administration of Drug | During Intubation | After Intubation | 45 mins Intraoperatively | At the end of Surgery | 15 minutes postoperatively | 2 hours postoperatively | 6 hours postoperatively | 12 hours postoperatively

次要结局

  • To compare and evaluate incidence of rescue antiemetic used with dexmedetomidine and dexamethasone.(To compare and evaluate side effects of dexmedetomidine and dexamethasone.)

研究者

发起方
Suchana Maji
申办方类型
Other [self]

研究点 (1)

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