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临床试验/CTRI/2018/01/011470
CTRI/2018/01/011470尚未招募不适用

A prospective randomised study to assess whether prophylactic atropine administration attenuates the negative haemodynamic effects of induction of anaesthesia with propofol and fentanyl.

Head of the department1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年1月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Atropine attenuates the fall in BP HR and MAP during induction of anaesthesia with propofol and fentanyl

研究概览

简要总结

Aim

To study the effect of atropine in suppressing the negative haemodynamic effects of induction agents with propofol and fentanyl during general anaesthesia

Materials and methodology

patients posted for elective surgery are selected

divided into two groups

group A receiving atropine 0.6mg/ml 1cc

group S receiving saline 1cc

Intervention

All patients will be kept on NPO status for 8 hrs before surgery

Patients will be randomized into two groups using closed envelope technique

On arrival to operation theatre ECG NIBP SPO2 will be connected

IV line with 18G cannula will be secured in any of the preipheral veins of upper limbs

Infusion of 500 ml crystalloid will be completed before induction of anaesthesia

Pateints will be premedicated with inj.midaz 1mg

Patients will be preoxygenated with 3 litres of o2 through face mask

Atropine or saline will be given according to the group assigned

Patients will be induce with Propofol 100mg and fentanyl 100mcg

Patients will be ventilated at a tidal volume of 8ml/kg with 4 litres o2 for 5 mins after administration of atracurium 0.5mg/kg

Then patients will be intubated with appropriate size cuffed ET tube

Baseline BP HR MAP will be recorded

All the above will be monitored every minute till 15 mins after induction.

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 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

  • 1 Patients posted for elective surgery 2 ASA I and II.

排除标准

  • 1 ASA III and IV 2 Patients with contraindications of atropine 3 Patients with IHD/CAD/DIABETIC NEUROPATHY 4 Patients with ECG showing tachyarrythmias 5 Emergency surgeries 6 Mallampatti grade III and IV 7 BMI>35 8 Anticipated difficult airway.

结局指标

主要结局

Atropine attenuates the fall in BP HR and MAP during induction of anaesthesia with propofol and fentanyl

时间窗: Starting point Time of induction with propofol and fentanyl | End point Monitored every minute till 15 mins after induction of anaesthesia

次要结局

未报告次要终点

研究者

发起方
Head of the department
申办方类型
Government medical college

研究点 (1)

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