Comparison of effect of low dose intratracheal and intravenous dexmedetomidine administration on recovery from general anaesthesia after abdominal surgery: a randomised double blinded study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The primary outcome will include severity of cough at extubation assessed by 4 point cough scale
研究概览
简要总结
Emergence from general anaesthesia can result in a number of undesirable side effects including cough, hypertension, tachycardia, and agitation. These side effects may cause haemorrhage from the surgical wound site and also increase the in intraocular and intracranial pressures. Dexmedetomidine emerges as a potent alpha-2-selective adrenoceptor agonist, inducing sympatholysis, sedation, and analgesia without compromising respiratory function. The instillation of local anesthetics and dexmedetomidine directly into the trachea emerges as a promising strategy to counter laryngeal reflexes, gaining credibility in real-world clinical practices. Hence our aim is to compare the efficacy of Intratracheal dexmedetomidine (Dex) vs Intravenous dexmedetomidine injection for recovery from general anaesthesia following abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •Individuals of both genders aged between 18 and 60 years, with a weight falling within the range of 40 to 80 kg with physical status American Society of Anaesthesiologists (ASA) I and II, undergoing elective abdominal surgery under general anaesthesia will be included.
排除标准
- •Long term use of sedative drugs (benzodiazepines, barbiturates), 2) Anticipated difficult airway, 3) Those who received alpha2 agonists preoperatively, 4) Patients who were transferred to open surgery during the operation were excluded from the final analysis.
结局指标
主要结局
The primary outcome will include severity of cough at extubation assessed by 4 point cough scale
时间窗: 0 minutes, 2 minutes, 5 minutes, 15 minutes, 30 minutes post extubation
次要结局
- Monitoring of hemodynamic parameters(5 min before anaesthesia(T0), immediately after administration of dexmedetomidine(T1), 5 min after DEXMEDETOMIDINE(T2), 10 min after DEXMEDETOMIDINE(T3), at end of surgery(T4), at awareness(T5), at extubation(T6), 2 min after extubation(T7), 5 min after extubation(T8), 15 min after extubation(T9), 30 min after extubation(T10))
研究者
Dr Chanda Khatri
Dr S N Medical college