CTRI/2025/01/079667尚未招募不适用
A COMPARATIVE STUDY OF IV DEXMEDETOMIDINE INFUSION VERSUS IV FENTANYL INFUSION FOR CONSIOUS SEDATION DURING MIDDLE EAR SURGERIES UNDER MONITORED ANAESTHESIA CARE-A RANDOMIZED CONTROLLED PILOT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- comparision of intraoperative sedation using the Ramsay Sedation Score,hemodynamic stability
研究概览
简要总结
A comparative randomized controlled pilot study examining IV dexmedetomidine versus IV fentanyl infusion for conscious sedation during middle ear surgery under monitored anesthesia care.Patients randomly divided into two groups Group D (IV dexmedetomidine) and Group F(IV fentanyl )
Monitored hemodynamic parameters
Assessed sedation levels using Ramsay Sedation Scale
Evaluated post-operative recovery, pain, and satisfaction scores
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18-60 years • Patients of either sex • ASA Grade: I and II • Patients undergoing middle ear surgeries under local anesthesia with MAC • Patients consenting to the procedure.
排除标准
- •Pregnancy and Lactating women Patients with Asthma Patients on Beta Blocker drugs MI in last 6 months, AF, Heart blocks Deranged renal profile Advanced liver disease (liver enzymes twice the normal range or higher) • History of chronic use of sedatives, narcotics and alcohol • Known sensitivity to Lignocaine or allergy to study drugs.
结局指标
主要结局
comparision of intraoperative sedation using the Ramsay Sedation Score,hemodynamic stability
时间窗: Intraoperative sedation using the Ramsay Sedation Score at 5 minutes, 15 minutes, and 30 minutes after the initiation of infusion.
次要结局
- • To assess intraoperative and postoperative analgesia.(• To assess intraoperative hemodynamic stability.)
研究者
Sandhya Khwaunju
Armed Forces Medical college,Pune
研究点 (1)
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