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临床试验/CTRI/2025/09/094426
CTRI/2025/09/094426尚未招募不适用

Comparison of preoperative magnesium sulphate versus dexmedetomidine nebulisation for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation in severe preeclampsia parturients undergoing caesarean section: A Randomised clinical study

JLN Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月8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
100
试验地点
1
主要终点
To assess changes in hemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure

研究概览

简要总结

Laryngoscopy and endotracheal intubation cause significant sympathetic stimulation, resulting in tachycardia and hypertension, responses that are exaggerated and potentially hazardous in severe preeclampsia due to already elevated vascular resistance. This randomised clinical study aims to compare the efficacy of preoperative nebulization with inj magnesium sulphate 40mg/kg versus preoperative nebulization with inj dexmedetomidine 1 microgram/kg in attenuating the pressor response during induction and intubation in preeclamptic parturients scheduled for caesarean section. Patient will be divided in two groups, Group D receiving inj dexmedetomidine nebulization and Group M receiving inj magnesium Sulphate nebulization. Patient is assessed for changes in heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure in peri-intubation period. This study will help us to compare efficacy of both of these agents in attenuating the hemodynamic response.

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 50.00 Year(s)(—)
性别
Female

入选标准

  • Parturients with severe preeclampsia undergoing caesarean section under general anaesthesia with asa physical status 1 and 2.

排除标准

  • ASA status more than 2 2) Mallampati grade more than 2 3) Allergic to study drug 4) Anticipated difficult intubation 5) Requiring more than 2 attempts at intubation 6)BMI 40 or more than 40kg/m2 7) Comorbidities 8) Emergency Caesarean section 9) Consent not given to participate in clinical study.

结局指标

主要结局

To assess changes in hemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure

时间窗: Assessed before nebulization, after completion of nebulization, at the time of laryngoscopy and intubation, at 1 min, 2min, 3min, 4min, 6min, 8min, 10min after intubation.

次要结局

  • Cough at time of extubation(At the time of extubation)
  • Post operative sore throat(At time of extubation, at 6hr post extubation and at 12hr post extubation)
  • Side effects of drug

研究者

发起方
JLN Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Arvind Khare

Jawahar lal Nehru Medical College

研究点 (1)

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