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临床试验/CTRI/2025/05/087160
CTRI/2025/05/087160尚未招募4 期

Comparasion of dexmedetomidine and remifentanil for sedation during awake fibre-optic intubation in patients with difficult airway- a randomized clinical control trial

IMS and SUM Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年5月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
88
试验地点
1
主要终点
To assess the ease of intubation between both the groups

研究概览

简要总结

Awake fiberoptic intubation AFOI is a well established technique for managing patients with difficult airways However the biggest challenge with AFOI is ensuring that patients are comfortable cooperative and not overly anxious while still maintaining their airway reflexes and spontaneous breathing

Dexmedetomidine a sedative that works on alpha2 adrenergic receptors is known for providing calmness pain relief and anxiety reduction without significantly affecting breathing On the other hand remifentanil a short acting opioid is commonly used for its strong pain relief and ability to suppress airway reflexes though it comes with a risk of respiratory depression if not carefully controlled

While both drugs are used in clinical practice for AFOI there is still no clear consensus on which one is better particularly in patients with difficult airways Since these patients are already at a higher risk of complications choosing the right sedation strategy could make a significant difference in their safety and comfort

Although previous studies have explored dexmedetomidine and remifentanil for AFOI most research has focused on patients with normal or mildly challenging airways There is limited evidence comparing these two sedatives specifically in cases where airway management is particularly difficult due to anatomical abnormalities trauma or other complications Additionally while both drugs are effective still dont have a clear understanding of which one provides a better balance between patient comfort intubation success and minimal side effects especially in high risk cases

Dexmedetomidine will offer a more stable sedation experience with fewer airway reflex disturbances better patient tolerance and more consistent hemodynamic stability compared to remifentanil

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
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

  • American Society of Anesthesiologists grades 1 and 2,Undergoing oral cancer or dental surgeries,Patients with limited mouth opening of less than 2 fingers.

排除标准

  • Patient not giving consent,known allergy to the anesthetics,Coagulation disorders,Pregnancy or breast feeding,Cardiovascular and neurological abnormalities,Non cooperative patients Patients belonging to ASA more than 2,Patients with alcohol or drug use.

结局指标

主要结局

To assess the ease of intubation between both the groups

时间窗: 1 minute, 5 minute, 10 minute, 15 minute intervals

次要结局

  • To assess intubation comfort score,To study complications, cardio respiratory status intra operatively,Ramsay Sedation scale,Airway obstruction score,Time for Intubation(1 minute, 5 minute, 10 minute, 15 minute intervals)

研究者

发起方
IMS and SUM Hospital
申办方类型
Private medical college

研究点 (1)

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