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临床试验/NCT02577432
NCT02577432已完成不适用

Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension

Dr. Soliman Fakeeh Hospital0 个研究点目标入组 124 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
124
主要终点
incidence of hypotension

研究概览

简要总结

Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate.

Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.

Design: A randomized, controlled clinical trial.

Setting: Single medical center from 5/2013 to 10/2014.

Patients & Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia.

Patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Parturient at full term.
  • Must be elective cesarean section.
  • Must be uncomplicated pregnancy

排除标准

  • Body weight <50 kg or >90 kg
  • Height ˂150 cm or >170 cm.
  • Pre-eclampsia.
  • Any major systemic disease.
  • Contraindication to regional anesthesia.
  • Allergy to used medications.

研究组 & 干预措施

(S) separate.

Active Comparator

fentanyl and hyperbaric bupivacaine (sequentially)

干预措施: fentanyl (Drug)

(S) separate.

Active Comparator

fentanyl and hyperbaric bupivacaine (sequentially)

干预措施: hyperbaric bupivacaine (Drug)

(M) mixed

Active Comparator

fentanyl and hyperbaric bupivacaine.(mixed)

干预措施: fentanyl (Drug)

(M) mixed

Active Comparator

fentanyl and hyperbaric bupivacaine.(mixed)

干预措施: hyperbaric bupivacaine (Drug)

结局指标

主要结局

incidence of hypotension

时间窗: intraoperative

Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.

时间窗: intraoperative

次要结局

未报告次要终点

研究者

发起方
Dr. Soliman Fakeeh Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Amr Aly Ismail Keera

Assistant professor

Dr. Soliman Fakeeh Hospital

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