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临床试验/CTRI/2024/06/069669
CTRI/2024/06/069669尚未招募4 期

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

M D M Hospital Dr S N Medical College Jodhpur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月8日最近更新:

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

发起方
M D M Hospital Dr S N Medical College Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Geeta Singariya

Dr S N medical collage Jodhpur

研究点 (1)

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