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临床试验/CTRI/2024/07/070396
CTRI/2024/07/070396尚未招募3 期

Comparison of hemodynamic effects of nebulized dexmedetomidine versus nebulized magnesium sulphate on attenuation of stress response during laryngoscopy and tracheal intubation- A randomized control trial

Yuvaraj karthikeyan1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2024年8月7日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
164
试验地点
1
主要终点
To compare the hemodynamic effects of preoperative nebulized dexmedetomidine and nebulized magnesium sulphate on laryngoscopy and intubation stress response attenuation

研究概览

简要总结

The purpose of this study is to compare the effect of preoperative nebulised dexmedetomidine and nebulized magnesium sulphate  on hemodynamic responses to laryngoscopy and endobronchial intubation . Patients coming for elective  surgery meeting the required inclusion criteria will be enrolled for this study. Information about the study will be conveyed and consent obtained in the preoperative period. Patients will be divided into two groups by computer-generated block randomization: Group A will receive dexmedetomidine(1mcg/kg body weight diluted with normal saline 4ml administered over 10-15 minutes ) and Group B will receive nebulized magnesium sulphate (10mg/kg with normal saline 4ml administered over 10-15 minutes)

All patients will have standard ASA monitoring with one intravenous (IV) lines.

Five minutes after completion of nebulization with the study drug, all patients will be induced with IV propofol upto 2mg/kg, fentanyl 2 mcg/kg, lignocaine 1.5mg/kg and vecuronium 0.1 mg/kg, in accordance with the current standard of care given in our hospital.  Anesthesia will be maintained with isoflurane to get a MAC of 1 until tracheal intubation. After 3 minutes of mask ventilation, laryngoscopy and endotracheal tube insertion. Episodes of hypotension will be treated with a bolus of Ephedrine hydrochloride 5mg or Phenylephrine 25-50 mcg . Bradycardia will be treated with 0.3-0.6 mg atropine bolus. Any hypertension or tachycardia will be treated with additional doses of propofol and/or fentanyl. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR), will be recorded at baseline and regular intervals. All incidences of hypertension, hypotension , tachycardia and bradycardia will be documented and the number of doses of rescue medication administered will be noted.

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 elective surgery and belonging to ASA physical status I to II.

排除标准

  • Patients with difficult airway, uncontrolled hypertension, heart disease with ejection fraction less than 40%, body mass index more than 35 kg/m2, history suggestive of hypersensitivity to drugs used during the study, bradycardia- heart rate less than 50 beats per minute, any heart block, hepatic impairment, renal impairment and pregnancy.

结局指标

主要结局

To compare the hemodynamic effects of preoperative nebulized dexmedetomidine and nebulized magnesium sulphate on laryngoscopy and intubation stress response attenuation

时间窗: 1 hour

次要结局

  • To assess the requirement of additional anesthetic drugs(fentanyl, propofol)in order to maintain the hemodynamics within 20% of baseline values(1 hour)

研究者

发起方
Yuvaraj karthikeyan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Yuvaraj karthikeyan

Christian Medical College

研究点 (1)

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