CTRI/2024/11/077470尚未招募不适用
Comparison of intravenous ketofol (ketamine plus propofol) and ketodex (ketamine plus dexmedetomidine) sedation during awake fiberoptic intubation in patients for cervical spine surgery A randomized control trial .
Dr Devyani Sharma1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1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
- 50
- 试验地点
- 1
- 主要终点
- Time taken from the start of the drug infusion till confirmation of intubation with capnography.
研究概览
简要总结
It is a randomized control trial aimed at comparing the effects of ketodex and ketofol for awake fiberoptic intubation in patients for cervical spine surgery in terms of intubating conditions , hemodynamic stability and patients and anesthesiologists satisfaction .
a total sample size of 50 patients will be taken in which 25 patients will recieve the drug infusion of ketofol and 25 patients will recieve the drug ketodex . The primary outcome is the the total time taken from start of infusion till confirmation in intubaion with capnography .The study will be done at PGIMER after CTRI registeration .
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •no anticipated difficult airway .
- •age group 18 to 65 years of both sexes .
- •BMI 18.5 -29.9 kg/m2 ASA 1 and 2 patients .
排除标准
- •ASA 3 and 4 patients Refusal of the patient Pregnancy/bleeding disorder Alcohol or substance abuse presence of cardiac or respiratory disease Psychological disturbance any known allergy to the study drugs coagulopathy hepatic or renal impairment.
结局指标
主要结局
Time taken from the start of the drug infusion till confirmation of intubation with capnography.
时间窗: 1 year
次要结局
- Patients tolerance to endoscopy and intubation(1 year)
- patients satisfaction 24 hours post operation(1 year)
- Anesthesiologist satisafaction(1 year)
- hemodynamic stability(1 year)
- 1 Number of patients requiring rescue drugs such as fentanyl
研究者
Devyani Sharma
PGIMER Chandigarh
研究点 (1)
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