Comparison of the efficacy of Magnesium Sulfate and Dexmedetomedine for attenuation of hemodynamic stress response to pneumoperitoneum in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stress Response to pneumoperitoneum as measured by increase in Heart Rate and Mean Arterial Blood Pressure
研究概览
简要总结
INTRODUCTION
Laparoscopic cholecystectomy is gaining popularity as it is cost-effective and has minimal blood loss due to small incision, early ambulation and recovery compared to conventional open procedure. The pneumoperitoneum is produced by administering CO2 in the peritoneal cavity which affects cardiovascular and pulmonary physiology and causes stress response.
AIMS AND OBJECTIVE:
The study’s primary objective is to compare hemodynamics (mean arterial pressure - MAP and Heart Rate - HR) between two groups. The secondary objective is to compare the adverse effects between the two groups.
MATERIALS AND METHODS: Approval of theinstitutional ethical committee is obtained. A total number of 60 patients aged between 30-60 years of either gender, belonging to ASA status I, and II posted for elective laparoscopic cholecystectomy surgeries will be randomly allocated into two equal groups using the computer-generated random list.
EXCLUSION CRITERIA -Patients with known cardiac abnormalities, Uncontrolled hypertension & diabetes mellitus, Pregnancy, Morbidly obese, History of allergy to any of the study drugs.
Group D willreceive Dexmedetomidine 1µg/kg in 100ml saline over 15 mins IV before induction, followed by 0.2µ/kg/hr.
GroupM willreceive Magnesium sulfate 40mg/kg IV in 100ml saline over 15mins before induction followed by 10 mg/kg/hr.
Intraoperative hemodynamic parameters like heart rate and mean arterial blood pressure(MAP) will be monitored.Baseline parameters (P0,) Before intubation(P1), After intubation(P2), Before peritoneal insufflation(P3), 5mins after peritoneal insufflation(P4), 15 mins after peritoneal insufflation(P5), 30mins after peritoneal insufflation(P6). 60 mins after peritoneal insufflation(P7), 5 mins after peritoneal deflation(P8),After extubation(P9),After patient shifted to PACU(P10).
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists Physical Status 1 and 2 posted for elective laparoscopic cholecystectomy under general anesthesia.
排除标准
- •Patients with known cardiac abnormalities, Uncontrolled hypertension & diabetes mellitus, Pregnancy, Morbidly obese, History of allergy to any of the study drugs.
结局指标
主要结局
Stress Response to pneumoperitoneum as measured by increase in Heart Rate and Mean Arterial Blood Pressure
时间窗: Baseline, 5 minutes, 15 minutes, 30 minutes and 60 minutes after peritoneal insufflation with CO2, 5 minutes after peritoneal deflation
次要结局
- adverse effects(intraoperative and post operative periods)
研究者
Dr. Sesham Sonu
Government Medical College, Kadapa