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临床试验/CTRI/2025/04/084441
CTRI/2025/04/084441尚未招募不适用

A Randomized study to compare the effect of single pre-operative dose of dexmedetomidine and fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia.

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年4月20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
44
试验地点
1
主要终点
To compare the effect of single pre operative dose of Dexmedetomidine and Fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia

研究概览

简要总结

Randomized and observational study to compare the effect of single pre-operative dose of dexmedetomidine and fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia. This study shall further help us to conclude a better drug for controlled attenuation of haemodynamics without any major side effects.

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

  • Patients willing to sign informed consent.
  • Male or female patients between ages of 18 to 60 years.
  • Patients belonging to American Society of Anaesthesiologists (ASA) physical status I and II.
  • Patients posted for elective surgeries requiring endotracheal intubation under general anaesthesia.
  • Patient having mouth opening more than 3cm Patient with Malampatti grade 1 and 2.

排除标准

  • Patients unwilling to participate in the study.
  • Patients belonging to ASA status 3 and 4 Patients having contraindication to endotracheal intubation/general anaesthesia.
  • Patient having mouth opening less than 3cm.
  • Patient with Mallampati grade 3 and
  • Body mass index more than 30 kg.m
  • patients taking anxiolytics, sedatives, antipsychotic, or antiepileptic drugs.
  • Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking beta blockers.
  • Patients with cerebrovascular, hepatic and renal diseases.
  • Psychiatric patients.
  • Patients with history of allergy to an alpha 2 adrenergic agonist and synthetic opioids.
  • Pregnancy and lactating women.

结局指标

主要结局

To compare the effect of single pre operative dose of Dexmedetomidine and Fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia

时间窗: To compare the effect of single pre operative dose of Dexmedetomidine and Fentanyl on haemodynamic response to endotracheal intubation under general anaesthesia (Baseline parameters before administration of the study drug, after 5 minutes during the administration of the study drug, just after administration of the study drug, after induction of anaesthesia, after intubation, and at 1,3,5,10,15 minutes post intubation.

次要结局

  • Patient haemodynamic parameters during extubation.(Post operative Sedation effect)

研究者

发起方
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Sendhooran S

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

研究点 (1)

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