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临床试验/CTRI/2024/02/062663
CTRI/2024/02/062663已完成4 期

A randomized single-blinded placebo control study of perioperative Dexmedetomidine infusion on 24 hour morphine consumption by patient controlled analgesia(PCA) in patients undergoing major neurosurgical procedures

Saveetha Medical College1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
24hr cumulative morphine consumption

研究概览

简要总结

Objective of the research project: To assess the post-operative opioid sparring effect of

perioperative Dexmedetomidine infusion in patients undergoing neurosurgical procedures with

post-operative Morphine consumption.

The primary objective is the comparison of cumulative morphine consumption in 24hrs

(PCA and initial titration)

Secondary objectives include comparing the time to first request for post-operative

analgesia, assessment and comparison of post-operative pain with Numerical rating

scale

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • ASA PS 3 Elective Neurosurgical procedures.

排除标准

  • Cardiac disorders, Impaired renal, liver and pulmonary functions Intellectual disability Long term use of ACE inhibitors, Beta blockers, Sedatives, Psychiatric medications Emergency cases.

结局指标

主要结局

24hr cumulative morphine consumption

时间窗: 1hr, 2hr, 4hr, 6hr, 8hr, 12hr and 24 hr postoperative period

次要结局

  • Time of First analgesic request(24 hours postoperative period)
  • Post operative pain assessment using Numerical Rating Scale(1, 2,4,6,8,12,24 hrs post operative period)
  • Incidence of nausea, Vomiting(24 hours postoperative period)

研究者

发起方
Saveetha Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Bharat Krishna

Saveetha Medical College

研究点 (1)

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