Comparing the Analgesic Effect of Intraperitoneal and Intravenous Magnesium Sulphate in Diagnostic Gynecological Laparoscopy
试验速览
- 阶段
- 2 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time for first dose of rescue analgesia
研究概览
简要总结
Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal cavity with its irritation effect on the diaphragm.Patients will be divided into two groups:
Intraperitoneal (IP) group (20 patients):They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.
Intravenous (IV) group (20 patients):They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20-44 years old females, (ASA) class I-II
排除标准
- •Patient refusal
- •Allergy to MgSO4
- •Atrio-ventricular conduction abnormalities
- •Drug abuse
- •Renal or hepatic or cardiovascular dysfunction
- •Prior long-term treatment with calcium channel blockers or magnesium
研究组 & 干预措施
Intraperitoneal magnesium sulfate (IP) group
They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then an intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.
干预措施: intraperitoneal Magnesium sulfate (Drug)
Intravenous magnesium sulfate (IV) group
They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy.
干预措施: intravenous magnesium sulfate (Drug)
结局指标
主要结局
Time for first dose of rescue analgesia
时间窗: 8 hours
1st time to feel pain
total analgesic doses
时间窗: 8 hours
total (ketorolac) analgesic consumption
次要结局
- post operative pain(8 hours)
- sedation(8 hours)
- adverse events(8 hours)
- serum mgso4 level(2 hours)
研究者
Fouad Soliman
Lecturer of Anesthesia and ICU
Sohag University