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临床试验/CTRI/2025/03/081941
CTRI/2025/03/081941尚未招募不适用

Comparative Evaluation Of Dexmedetomidine versus Magnesium Sulphate by Nebulization to attenuate hemodynamic stress response to Intubation in Patients undergoing elective surgery under General Anaesthesia

Guru Gobind Singh Medical College Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月10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
120
试验地点
1
主要终点
To evaluate the alteration in the hemodynamic stress response to intubation in terms of Systolic Blood Pressure with nebulized dexmedetomidine (1ug/kg)

研究概览

简要总结

A randomized, prospective, double blinded interventional comparative study will be conducted on 120 patients undergoing surgeries under general anaesthesia. Patients were randomized into 2 groups, of 60 each to be nebulised with magnesium sulphate (30mg/kg(Group M)) ,dexmedetomidine(1mcg/kg(Group D)) diluted upto 5ml before induction. Readings of systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), will be recorded at various time intervals.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing surgeries under general anaesthesia.
  • Patients of age group between 18 to 65 years of either gender.
  • American Society of Anaesthesiologist grade I and II.

排除标准

  • Patients with a history of allergy to the study drugs.
  • Patients in whom intubation time exceeded 20 seconds or in cases where first attempt to intubate has failed.
  • Refusal of consent.
  • Patients with body mass index (BMI) more than 30 kg/m2, a history of cardiovascular diseases like ischaemic heart disease and uncontrolled hypertension, a history of alcohol intake, chronic analgesic or drug abuse, and pregnant patients will be excluded from the study.
  • Patients with difficult airway (for example: mouth opening less than 2 fingers, MPG more than 2,
  • Neck movement: flexion / extension -limited).

结局指标

主要结局

To evaluate the alteration in the hemodynamic stress response to intubation in terms of Systolic Blood Pressure with nebulized dexmedetomidine (1ug/kg)

时间窗: Baseline,immediately after nebulization,1 minute after tracheal intubation, 5 minutes after tracheal intubation,10 minutes after tracheal intubation

To evaluate the alteration in the hemodynamic stress response to intubation in terms of Systolic Blood Pressure with nebulized magnesium sulphate (30mg/kg)

时间窗: Baseline,immediately after nebulization,1 minute after tracheal intubation, 5 minutes after tracheal intubation,10 minutes after tracheal intubation

次要结局

  • to compare the DBP, HR, MAP, SpO2 with nebulized dexmedetomidine (1ug/kg) and with nebulized magnesium sulphate (30mg/kg)(Till 10 mins of intubation)
  • To compare the incidence of hypotension, bradycardia or sedation after nebulization with Dexmedetomidine and Magnesium Sulphate(Till the end of surgery)

研究者

发起方
Guru Gobind Singh Medical College Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Lavania Garg

GGSMCH, Faridkot

研究点 (1)

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