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临床试验/CTRI/2024/07/070076
CTRI/2024/07/070076尚未招募2/3 期

Comparison of Nebulized Ketamine-Lignocaine versus Nalbuphine-Lignocaine inhalation on intubating conditions and hemodynamic responses during Awake Fiberoptic Intubation

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年7月23日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
64
试验地点
1
主要终点
To Compare the facial grimace scores, cough scores, sedation score between the groups

研究概览

简要总结

This study is a randomized, double blind trial comparing compare the efficacy of ketamine and nalbuphine with lignocaine in blunting the hemodynamic response during Awake Fibreoptic Intubation that is being conducted at AIIMS Raebareli. The primary outcome is to compare the facial grimace scores, cough scores and sedation score between the groups as well as tp compare the hemodynamic parameters among the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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

  • American society of anaesthesiology grade I and II
  • Patients suspected to have difficult intubation requiring fibreoptic as an aid.

排除标准

  • 1.Pregnancy 2.Coagulopathy (Bleeding airway) 3.Cerebrovascular disease 4.systemic infection 5.Inability to understand the study protocol 6.Allergy to either of the drugs ketamine/nalbuphine/lignocaine 7.Psychopathy that may affect patient evaluation 8.Patient refusal 9.Pateints with significant renal, hepatic, pulmonary and neurological diseases 10.Pateints with history of drug abuse.

结局指标

主要结局

To Compare the facial grimace scores, cough scores, sedation score between the groups

时间窗: 24hrs

To compare the hemodynamic parameters among the two groups

时间窗: 24hrs

次要结局

  • To Compare Time taken for AFOI and Patient satisfaction scores in both the groups(12 hours)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Mukesh sirvi

All India Institute of Medical Sciences

研究点 (1)

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