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临床试验/CTRI/2025/02/080198
CTRI/2025/02/080198尚未招募2 期

COMPARISON OF LIGNOCAINE VS DEXMEDETOMIDINE NEBULIZATION IN ATTENUATING PRESSOR RESPONSE TO PNEUMOPERITONIUM DURING SHORT DURATION GYNEACOLOGICAL LAPAROSCOPIC SURGERIES -A DOUBLE BLIND RANDOMIZED COMPARATIVE STUDY

Dr SAINATH T1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年2月26日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
To measure and compare the mean arterial pressure variation due to pneumoperitoneum between the two study groups.

研究概览

简要总结

This is randomised double blinded trail comparing pressor response attenuation efficiency of nebulization 4% lignocaine and nebulization dexmeditomedine in patients undergoing short duration laparoscopic surgery in 66 patients who are ASA 1 and ASA 2 physical status for the duration of 15 months. This study will be conducted in Mahatma Gandhi medical College and research institute, pondicherry, India. Primary outcome - to measure and compare mean arterial pressure variations due to pneumoperitonium between two study groups. Secondary outcome - To measure and compare intra op heart rate, blood pressure, opioid requirement and post operative pain score variations between two study groups.

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
Female

入选标准

  • American society of anesthesiologists patient status (ASA PA) 1 and 2
  • Surgery duration less than 3 hours.

排除标准

  • emergency cases
  • patients with decreased autonomic control such as uncontrolled diabetic patients
  • Anosmia, allergic rhinitis
  • patients with preoperative hypotension, bradycardia, dysrhythmia, severe cardiac diseases, complete heart block
  • patient with sinus bradycardia with HR lessthan 50/min, patient taking beta blockers, hepatic or renal dysfunction, obese patients with (BMI more than 30kg/sq meter)
  • patients with history of sleep apnea
  • Known allergy to either of the study drug will be excluded from the study.

结局指标

主要结局

To measure and compare the mean arterial pressure variation due to pneumoperitoneum between the two study groups.

时间窗: 15 months

次要结局

  • 1.To measure and compare the heart rate, blood presure variation due to pneumoperitoneum between the two study groups(2. To compare the intra operative opioid requirement in the two study groups.)

研究者

发起方
Dr SAINATH T
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr SAINATH T

Mahatma Gandhi medical College and research institute

研究点 (1)

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