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临床试验/CTRI/2021/07/035276
CTRI/2021/07/035276已完成2 期

Comparison of intravenous Dexmedetomidine with Dexmedetomidine-Dexamethasone combination for prevention of Post-Operative Nausea and Vomiting in adult patients after abdominal surgeries

Department of Anaesthesia and Intensive Care1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年2月8日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Nausea

研究概览

简要总结

This is a prospective and interventional randomised comparative study to compare the effect of IV Dexmedetomidine with IV Dexmedetomidine-Dexamethasone combination with Normal Saline as control in preventing PONV in patients following abdominal surgeries under general anaesthesia using a Numerical Rating Scale in 75 patients of ASA physical status I/II of either gender of 18-60 years of age. The primary outcome measured will be incidence/frequency/severity of Nausea and incidence/frequency of Vomiting at regular time intervals post-op for up to 24 hours. The secondary outcomes measured will be post-op sedation using Ramsay Sedation Scale and post-op pain using Visual Analog Scale.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator 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

  • ASA physical status I/II.
  • Patients undergoing abdominal surgeries under general anaesthesia.

排除标准

  • Patients with previous history of post-operative nausea and vomiting, abdominal surgery, cardiovascular or cerebrovascular comorbidities, diabetes mellitus.
  • Patients with history of treatment with antiemetic or glucocorticoids.
  • Patients with BMI>30 kg/m2.

结局指标

主要结局

Nausea

时间窗: End of surgery | 1 hour post-op | 3 hour post-op | 6 hour post-op | 9 hour post-op | 12 hour post-op | 24 hour post-op

Incidence and frequency of vomiting

时间窗: End of surgery | 1 hour post-op | 3 hour post-op | 6 hour post-op | 9 hour post-op | 12 hour post-op | 24 hour post-op

次要结局

  • Sedation(End of surgery)
  • Pain(End of surgery)

研究者

发起方
Department of Anaesthesia and Intensive Care
申办方类型
Government medical college

研究点 (1)

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