Comparison of dexmedetomidine and fentanyl in attenuation of haemodynamic response following laryngoscopy and endotracheal intubation
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To study and compare the change in HR, systolic blood pressure (SBP), diastolic blood pressure (DBP), MAP and SpO2 between the two groups of patients during laryngoscopy and endotracheal intubation.
研究概览
简要总结
The study will compare the effect of dexmedetomidine and fentanyl on haemodynamic parameters (Heart rate, blood pressure, oxygen saturation) following laryngoscopy and endotracheal intubation in patients posted for laparoscopic cholecystectomy. Laryngoscopy and endotracheal intubation after induction of general anaesthesia is associated with a stress response leading to rise in heart rate and blood pressure. Fentanyl and dexmedetomidine have been used to mitigate this stress response in patients undergoing general anaesthesia. This study aims to compare the efficacy of dexmedetomidine and fentanyl in attenuation of haemodynamic changes and to also assess the sleep scores in the post operative period.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in age group of 18-60 years.
- •2.American Society of Anesthesiologists (ASA) Status I and II.
- •3.Patients undergoing laparoscopic cholecystectomy requiring general anaesthesia with endotracheal intubation.
排除标准
- •Refusal of patient.
- •Morbid obesity (BMI more than 35 kg/m2).
- •Surgery duration more than 3 hours.
- •Patients at increased risk of aspiration like GERD, peptic ulcer, non-fasting status.
- •Known or anticipated difficult tracheal intubation or facemask ventilation.
- •Cardiorespiratory or cerebrovascular disease.
- •Pregnant or lactating females.
- •Contraindications or allergy to dexmedetomidine and fentanyl.
- •Patient with coagulopathy and bleeding disorder.
结局指标
主要结局
To study and compare the change in HR, systolic blood pressure (SBP), diastolic blood pressure (DBP), MAP and SpO2 between the two groups of patients during laryngoscopy and endotracheal intubation.
时间窗: Baseline, immediately after intervention, at the time of ETT insertion, at 1 min, 3 min, 5 min, 8 min, 10 min after endotracheal tube insertion.
次要结局
- 1. To study post operative sedation according to Ramsay Sedation Score (RSS).(2. To study adverse effects : Bradycardia, hypotension, nausea, vomiting, respiratory depression.)
研究者
Dr Deepak Thapa
Government Medical College and Hospital, Chandigarh