COMPARATIVE STUDY OF HYPERBARIC BUPIVACAINE AND FENTANYL GIVEN EITHER AS A MIXTURE OR SEQUENTIALLY FOR SUBARACHNOID BLOCK IN PATIENTS UNDERGOING CAESAREAN SECTION

Vardhman Mahavir Medical College1 个研究点分布在 1 个国家目标入组 180 人开始时间: 2018年1月4日最近更新: 2018年12月3日

试验速览

阶段: 1 期
状态: 尚未招募
发起方
入组人数: 180
试验地点: 1
主要终点: To evaluate the efficacy of hyperbaric bupivacaine and fentanyl given either as a mixture or sequentially for subarachnoid block in terms of 1) Block characteristics, 2) Haemodynamic parameters 3) Time required to achieve sensory block height (T5) for caesarean section.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

comparison of hyperbaric bupivacaine and fentanyl injected intrathecally either by single syringe or different syringes sequentially .

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 35.00 Year(s)（—）
性别: Female

入选标准

•Adult ASA physical status I, II with height 145-165 cm and Body mass index (BMI) < 35 kg/m2.

排除标准

•Known coagulation abnormality or bleeding diathesis, local infection at the site of spinal injection, raised intracranial tension, chronic hypertension, severe hypotension, hypovolaemia, cord prolapse, hypersensitivity to local anaesthetic or fentanyl.

结局指标

主要结局

To evaluate the efficacy of hyperbaric bupivacaine and fentanyl given either as a mixture or sequentially for subarachnoid block in terms of 1) Block characteristics, 2) Haemodynamic parameters 3) Time required to achieve sensory block height (T5) for caesarean section.

时间窗: Before giving surgical incision

次要结局

To evaluate the duration of sensory and motor block, total dose of vasopressor and neonatal outcome as assessed by Umbilical cord blood gas analysis, Apgar Score and need for Neonatal Resuscitation in above patients(at the time of giving subarachnoid block, during surgery and post operative period)

研究者

发起方

Vardhman Mahavir Medical College

申办方类型

Government medical college

研究点 (1)

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