Comparison of Oral Gabapentin vs Nebulized Dexmedetomidine for anxiolysis and hemodynamic stability in awake fiberoptic intubation a Prospective Randomized double blind study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparision between the anxiety scores of patients in both intervention and comparator group during the procedure
研究概览
简要总结
The purpose of my study is to compare the effect of oral Gabapentin with nebulized Dexmedetomidine in maintaining anxiety & hemodynamic stability in the patients undergoing awake fiberoptic intubation.
It is a prospective, double blind, randomized control trial which is to be done over a time period of 1 year.
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 belonging to ASA Grades-I, II status Patients with difficult airway.
排除标准
- •Refusal of the patient to participate in the study Prolonged duration of procedure (awake fiberoptic intubation) Pt allergic to the study drugs Patients with active URTI Patients with acute facial/nasal trauma history.
结局指标
主要结局
Comparision between the anxiety scores of patients in both intervention and comparator group during the procedure
时间窗: Anxiety score will be recorded 15 mins before the procedure(baseline) and during the procedure
Anxiety score:
时间窗: Anxiety score will be recorded 15 mins before the procedure(baseline) and during the procedure
0: Patient quiet and comfortable
时间窗: Anxiety score will be recorded 15 mins before the procedure(baseline) and during the procedure
1: Patient uneasy
时间窗: Anxiety score will be recorded 15 mins before the procedure(baseline) and during the procedure
2: Patient worried or anxious
时间窗: Anxiety score will be recorded 15 mins before the procedure(baseline) and during the procedure
3: Patient very worried or very upset.
时间窗: Anxiety score will be recorded 15 mins before the procedure(baseline) and during the procedure
次要结局
- To compare both the groups on basis of hemodynamic stabillity(Observation taken at)
- to compare both groups on terms of sedation scoring according to Ramsay scale
- To compare the patient comfort score in both the groups(Patient comfort score-)
- To compare airway obstrction score in both groups(Airway obstruction score:)
- To compare the cough score of both the groups(Cough Score-)
研究者
Dr Asish Mohapatra
IMS and SUM HOSPITAL