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临床试验/CTRI/2025/10/096337
CTRI/2025/10/096337尚未招募不适用

Comparison of oral pregabalin and intravenous dexmedetomidine in attenuating hemodynamic response to laryngoscopy and intubation : A randomized controlled study

SHUBHADA BHAGAT1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月1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
60
试验地点
1
主要终点
To determine whether a statistically significant reduction in hemodynamic response to laryngoscopy and intubation occurs with 150 mg oral pregabalin as compared to 1 mcg/kg of iv dexmedetomidine.

研究概览

简要总结

This is a prospective, randomised, double blind, single centre study which aims to compare the efficacy of oral pregabalin and intravenous dexmedetomidine for attenuating the hemodynamic response to laryngoscopy and intubation in patients scheduled for elective surgery under general anaesthesia. A total of 60 patients will be recruited, 30 in each group. HR, SBP, DBP and MAP will be noted at 1 min, 3 min, 5 min and 10 min postintubation. Side effects if any will be noted. Data will be compiled and appropriate statistical tests will be used to compile the results.

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 60.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 scheduled for elective surgery under general anaesthesia requiring orotracheal intubation.

排除标准

  • Following patients will be excluded from the study 1 Refusal to consent 2 Anticipated difficult airway 3 Patients whose intubation procedure will last more than 15 seconds.
  • 4 Patients with known allergy to study drugs 5 Patients requiring more than 1 intubation attempt 6 Neurosurgery patients 7 Cervical spine instability 8 Patients having history of cardiac or liver disease 9 Patients having baseline heart rate less than 50 in min or having AV blocks 10 Morbid obesity 11 Pregnant and lactating females.

结局指标

主要结局

To determine whether a statistically significant reduction in hemodynamic response to laryngoscopy and intubation occurs with 150 mg oral pregabalin as compared to 1 mcg/kg of iv dexmedetomidine.

时间窗: HR, SBP, MAP, DBP at 1 min, 3 min, 5 min and 10 min post intubation

次要结局

  • Side effects like bradycardia, hypotension in intraoperative and postoperative period. Sedation, nausea, vomiting will be noted in postoperative period.

研究者

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

SHUBHADA BHAGAT

PGIMS, ROHTAK, HARYANA

研究点 (1)

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