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临床试验/CTRI/2019/08/020923
CTRI/2019/08/020923已完成不适用

A STUDY TO EVALUATE THE ROLE OF DEXAMETHASONE IN PROPHYLAXIS OF POST OPERATIVE NAUSEA AND VOMITING IN LAPROSCOPIC CHOLECYSTECTOMY

ESI PGIMSR1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年2月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
To determine if there any difference in post operative Nausea nad Vomiting when Dexamethasone is used in elective laproscopic cholecystectomy under general anaesthesia

研究概览

简要总结

Long is among the most common complications after surgery, affecting more than 30% of patients. It is reported by patients to be among the top five undesirable outcomes. A systematic review has shown laproscopic surgery and increasing duration of surgery as independent predictors of PONV. Dexamethasone is a corticosteroid that influences patient outcome. It has been assesed in prevention of PONV in intermediate and low risk surgery. Post operative pain is a main reason for delayed discharge. Opiods are ttraditionally used for acute post operative pain relief but can lead to side effects like nausea and vomiting and itching. Co analgesic drugs reduce the amount of opiods needed. Dexamethasone has been evaluated as a co analgesic due to it`s anti inflammatory effect as well as effect on pain pathway. We aim to asses the effect of Dexamethasone on post operative nausea and vomiting and post operative pain medicine requirement.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA Class 1-2
  • Patients undergoing elective laproscopic cholecystectomy.

排除标准

  • Patient refusal
  • Patients who are pregnant or who have uncontrolled diabetes, glaucoma (all patients had blood glucose concentrations checked to exclude undiagnosed hyperglycaemia).
  • Those with a known adverse reaction to dexamethasone or who were taking any systemic steroids (excluding steroid inhalers, suppositories, pessaries, eye drops, one-off local injections to a joint, or topical preparations) were excluded from the trial.
  • Patients previously taking regular oral or intravenous steroids had to have stopped taking these drugs at least three months before trial entry to be eligible.

结局指标

主要结局

To determine if there any difference in post operative Nausea nad Vomiting when Dexamethasone is used in elective laproscopic cholecystectomy under general anaesthesia

时间窗: 0, 2, 6, 12 and 24 hours post operatively

次要结局

  • •To determine difference in intra operative pain by using hemodynamic parameters(•To determine difference in post operative pain by using the Visual Analogue Scale.)

研究者

发起方
ESI PGIMSR
申办方类型
Government medical college

研究点 (1)

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