Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- analgesia after laparoscopic cholecystectomy
研究概览
简要总结
Study the effect of adding Magnesium sulfate to TAP block in analgesia after laparoscopic cholecystectomy.
详细描述
After approval of local ethical committee, consent will be obtained from 90 patients scheduled for laparoscopic cholecystectomy in GEC center, Mansoura University, Egypt. Patients will be of either ASA I and II, with Age ranging from 18-40 years, and BMI less than 35. Patients will be randomized into 3 groups (using closed envelope technique in blocks of 18); Controlled group (C group), Bupivacaine group (B group), Bupivacaine Magnesium group (M group).
Anesthesia induction will be the same in the three groups (Propofol 1-1.5mglkg, Fentanyl 1 mic/kg, Atracrium 0.5 mg/kg) then Sevoflorane inhalational anesthesia for maintainace in 0.4 oxygen/air mixtures.
In both M group and B group, preemptive US guided Subcostal TAP block (Toshiba Xario, Japan) was performed on both sides using 20 ml volume (0.25 Bupivacaine in B group or 0.25 Bupivacaine plus 0.5 gm MgSo4 in M group). Surgical sterilization will be started 5 minutes after the block and surgery started5 minutes later. Hemodynamic data (HR, MAP) will be collected immediately after induction, at start of surgery, and each 10 minutes later.
At the end of surgery, and after closure of surgical ports, anesthesia was terminated and extubation done when patients fulfilled the required criteria. Postoperative hemodynamic data (HR, MAP), VAS, and PONV will berecorded at 0, 1, 2, 6, 12, 24 hours after surgery, Ramsay sedation was recorded at 0, 1, 2, 6 hours postoperatively. Boluses of Morphine (0.02 mg/kg) will be given whenever VAS ≥4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 50 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II for lap cholecystectomy
排除标准
- •ASA III, IV
研究组 & 干预措施
Magnesium sulfate group
US guided TAP with magnesium sulfate
干预措施: bupevecaine (Drug)
Magnesium sulfate group
US guided TAP with magnesium sulfate
干预措施: Magnesium Sulfate (Drug)
B group
TAP bupevecaine
干预措施: bupevecaine (Drug)
C group
control TAP saline
干预措施: saline (Drug)
结局指标
主要结局
analgesia after laparoscopic cholecystectomy
时间窗: 24 hours
次要结局
未报告次要终点
