Comparison of Dexmedetomidine and Magnesium sulphate as adjuvant to Bupivacaine in ultrasound guided right oblique subcostal Transversus Abdominis Plane block for post operative analgesia in patients undergoing Laparoscopic cholecystectomy.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the duration of post operative analgesia (Time to first rescue analgesia as per Visual Analogue Scale for pain) using Magnesium sulphate and Dexmedetomidine as adjuvant to Bupivacaine in ultrasound guided right oblique subcostal Transversus Abdominis Plane Block in patients undergoing Laparoscopic Cholecystectomy.
研究概览
简要总结
In this study we plan to compare Dexmedetomidine and Magnesium sulphate as adjuvant to Bupivacaine in ultrasound guided right oblique subcostal Transversus Abdominis Plane block for post operative analgesia in patients undergoing Laparoscopic cholecystectomy. Patients will be randomly allocated into 2 groups of 30 patients each. Group BM will receive magnesium sulphate as adjuvant to BUPIVACAINE whereas group BD will receive DEXMEDETOMIDINE as adjuvant with BUPIVACAINE.
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Each patient will be assessed for pain at rest with VAS Scoring system at 0, 1hour, 2hours, 6hours , 12hours and 24hours postoperatively.
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Duration of analgesia – time duration between administration of block to the administration of first rescue analgesia(Injection Diclofenac 75mg IV) to the patient will be noted. (Rescue analgesia is administered when the patient complaints of breakthrough pain or on assessment VAS score is more than 3).
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The total amount of rescue analgesics consumed in the initial 24 hours is calculated.
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Evaluation of changes in the hemodynamic parameters (SBP/DBP/MAP and heart rate)
in intraoperative period and 24 hours post operatively.
- Assessment of post operative sedation using Ramsay sedation score at
0hr,1hour,2hours,6hours,12hours,24hours post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All Patients belonging to American Society of Anaesthesiologists(ASA) grade I and II and aged between 18–65 years of both genders, undergoing elective laparoscopic cholecystectomy with duration of surgery less than 2 hours are included in the stud.
排除标准
- •History of allergy to drugs used in the study.
- •Infection or inflammation at the site of block application
- •Pregnant women
- •Those with a BMI of 30 and above.
- •Patients who have cognitive disability or unable to understand the VAS score.
结局指标
主要结局
To compare the duration of post operative analgesia (Time to first rescue analgesia as per Visual Analogue Scale for pain) using Magnesium sulphate and Dexmedetomidine as adjuvant to Bupivacaine in ultrasound guided right oblique subcostal Transversus Abdominis Plane Block in patients undergoing Laparoscopic Cholecystectomy.
时间窗: Post operatively at 0 hour , 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
次要结局
- 1. To determine the total amount of analgesics consumed in the initial 24 hours .(2. To evaluate changes in the hemodynamic parameters( Blood pressure and Heart rate))
研究者
Dr Mohammed Samjad E U
Vardhman Mahavir Medical College and Safdarjung Hospital