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临床试验/CTRI/2023/05/052837
CTRI/2023/05/052837尚未招募2/3 期

COMPARATIVE EVALUATION OF HAEMODYNAMIC RESPONSE TO INTUBATION WITH PROPOFOL,KETAMINE AND KETOFOL

M REETHM1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月9日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Haemodynamic stability in terms of systolic blood pressure, diastolic blood pressure and mean arterial pressure are maintained when patient is induced with ketofol (combination of propofol and ketamine ) rather than when used alone as an induction agents

研究概览

简要总结

Laryngoscopy and tracheal intubation are commonly used for airway management during general anesthesia.Propofol and ketamine are commonly used as an induction agents. Propofol has cardiovascular and respiratory depressant side effects whereas ketamine stimulates the cardiovascular system elevating heart rate, blood pressure and cardiac output.We hypothesise that combination of propofol-ketamine provides better Haemodynamic stability when compared to propofol and ketamine alone because of its distinct pharmacodynamic properties

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients undergoing elective surgery under general anesthesia and with valid consent 2.ASA grade 1 and 2 patients.

排除标准

  • 1.Emergency surgeries 2.Prior sensitization or allergic reaction to propofol, ketamine, soy or egg products hemodynamic instability 3.Head injury 4.Increased intracranial or intraocular pressure 5.Pregnancy.

结局指标

主要结局

Haemodynamic stability in terms of systolic blood pressure, diastolic blood pressure and mean arterial pressure are maintained when patient is induced with ketofol (combination of propofol and ketamine ) rather than when used alone as an induction agents

时间窗: Baseline , 1 minute ,3minutes , 5 minutes ,15 minutes after intubation

次要结局

  • Decrease in post operative nausea and vomiting and decreased incidence of hallucinations(Immediately after extubation, 15 minutes , 30 minutes and 1 hour after extubation)

研究者

发起方
M REETHM
申办方类型
Research institution and hospital

研究点 (1)

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