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临床试验/NCT02533284
NCT02533284Unknown不适用

Magnesium Sulfate for TAP Analgesia During Laparoscopic Cholecystectomy

Mansoura University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年1月最近更新:
适应症
干预措施

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

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

Experimental

US guided TAP with magnesium sulfate

干预措施: bupevecaine (Drug)

Magnesium sulfate group

Experimental

US guided TAP with magnesium sulfate

干预措施: Magnesium Sulfate (Drug)

B group

Experimental

TAP bupevecaine

干预措施: bupevecaine (Drug)

C group

Placebo Comparator

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AlRefaey Kandeel

Dr

Mansoura University

研究点 (1)

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