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临床试验/CTRI/2025/02/080593
CTRI/2025/02/080593尚未招募4 期

A COMPARATIVE STUDY OF KETAMINE PROPOFOL AND KETAMINE DEXMEDETOMIDINE FOR IV SEDATION IN SHORT PROCEDURES A RANDOMIZED CONTROL STUDY

Trichy SRM Medical College and Research Centre1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Time to first rescue ketamine bolus dose,

研究概览

简要总结

Moderate to deep sedation is a prerequisite for short surgical procedures. It can be achieved by using individual drugs or in combination of drugs. The combination of drugs enhance the desired effect and nullify each other drugs adverse effects. The aim of our study is to compare the safety and efficacy of ketadex( ketamine Dexmedetomidine) intravenously with ketofol ( ketamine propofol) intravenously in short duration procedures with stable hemodynamics and lesser adverse effects.

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
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • American soceity of anaesthesiologist grade 1&2 patients, weight 40-80kgs, patients undergoing elective short duration daycare surgical procedures.

排除标准

  • Patient refusal, patients allergic to any drugs, patients with any uncontrolled systemic illnesses American soceity of anaesthesiologist grade 3&4 ,.

结局指标

主要结局

Time to first rescue ketamine bolus dose,

时间窗: Time of 2nd dose of ketamine after 1st dose of ketamine, | total number of injection ketamine , | sedation score baseline, 10minutes, 20minutes, 30minutes after propofol or dexmedetomidine injection in both groups, | recovery time and sedation score postoperatively 10minutes, 20minutes, 30minutes

total number of rescue boluses,

时间窗: Time of 2nd dose of ketamine after 1st dose of ketamine, | total number of injection ketamine , | sedation score baseline, 10minutes, 20minutes, 30minutes after propofol or dexmedetomidine injection in both groups, | recovery time and sedation score postoperatively 10minutes, 20minutes, 30minutes

sedation score,

时间窗: Time of 2nd dose of ketamine after 1st dose of ketamine, | total number of injection ketamine , | sedation score baseline, 10minutes, 20minutes, 30minutes after propofol or dexmedetomidine injection in both groups, | recovery time and sedation score postoperatively 10minutes, 20minutes, 30minutes

recovery time after last rescue bolus

时间窗: Time of 2nd dose of ketamine after 1st dose of ketamine, | total number of injection ketamine , | sedation score baseline, 10minutes, 20minutes, 30minutes after propofol or dexmedetomidine injection in both groups, | recovery time and sedation score postoperatively 10minutes, 20minutes, 30minutes

次要结局

  • Pulse rate, systolic blood pressure, diastolic blood pressure, oxygen saturation, vomiting,(Pulse rate , systolic blood pressure, diastolic blood pressure, , oxygen saturation baseline,preinduction, 5,10,20,30,40 minutes intraoperatively,)

研究者

发起方
Trichy SRM Medical College and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

B.SUNDARI

TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

研究点 (1)

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