Comparison between Dexmedetomidine and Magnesium sulphate as adjuvants to propofol for postoperative recovery in patients undergoing Endoscopic Retrograde Cholangiopancreatography under Monitored Anaesthesia Care A Randomised Comparative Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare quality of postoperative recovery from anesthesia in terms of modified Aldrete score in patients undergoing endoscopic retrograde cholangiopancreatography under monitored anesthesia care with dexmedetomidine and magnesium sulphate as adjuvants to propofol
研究概览
简要总结
This study will be conducted in the Department of Anaesthesiology in DR S N Medical College and the associated group of hospitals. To ensure inclusion in the study, each patient will be subjected to a detailed pre-anaesthetic evaluation based on detailed history from patients/attenders, thorough physical examination, and pre-anaesthetic airway assessment. Baseline investigations will be done in all the patients to rule out any abnormalities. The purpose and detailed procedure will be explained to the patients. Written informed consent will be taken from all the patients about the procedure. All patients will be kept nil by mouth as per standard guidelines before the scheduled time of surgery.The patient’s NBM status will be confirmed before the scheduled time of surgery. After arrival to the operating room, routine parameters like heart rate, ECG, pulse oximetry and non-invasive blood pressure will be recorded (for the baseline values). The intravenous line will be secured using an 18/20 G IV cannula and Inj. Ringer Lactate will be started slowly.
The randomization will be done on a computer-generated random number chart using block randomization (1:1) and allocation concealment will be done by an opaque, sealed envelope method opened during pre-anesthetic checkup. All patients will be randomly allocated into two groups, Group D (dexmedetomidine and propofol) and Group M (magnesium sulphate and propofol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator 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
- •The adult patients, aged 18 to 60 years of both genders, belong to ASA PS I and II, undergoing ERCP under Monitored anaesthesia care.
排除标准
- •Patient refusal
- •History of any allergy to related medications
- •Patients receiving magnesium sulphate supplementation
- •Patients with psychiatric history, myopathy, neurological disease and other comorbidities.
- •Pregnant woman
- •Procedure time greater than 60 minutes.
结局指标
主要结局
To compare quality of postoperative recovery from anesthesia in terms of modified Aldrete score in patients undergoing endoscopic retrograde cholangiopancreatography under monitored anesthesia care with dexmedetomidine and magnesium sulphate as adjuvants to propofol
时间窗: 120 mins
次要结局
- Hemodynamic monitoring(Total propofol consumption)
研究者
Geeta Singariya
Dr S N medical collage Jodhpur
