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临床试验/CTRI/2021/07/034806
CTRI/2021/07/034806招募中3 期

Randomized double blind control trial between intrathecal Buprenorphine and intrathecal Fentanyl as an adjuvant to Bupivacaine in spinal anaesthesia for lower segment caesarean section

Bharati Vidyapeeth Deemed to be University medical college and research center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年7月15日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
•post Operative regain of sensory block and motor block

研究概览

简要总结

The study is randomized, double blind, trial Comparing the efficacy between intrathecalbuprenorphine and Fentanyl as an adjuvant to bupivacaine in spinal anaesthesia in LowerSegment Cesarean Section for duration of sensory and motor block for surgery and duration of 1st rescue analgesia in post operative period and number of analgesic requirements in 24 hours postoperatively.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 未提供

排除标准

  • •ASA III/IV/V •Patients with comorbidites during pregnancy- gestational diabetes mellitus, pregnancy induce hypertension, heart disease •Contraindications of spinal anaesthesia- raised intracranial pressure, local infection, coagulation disorders.

结局指标

主要结局

•post Operative regain of sensory block and motor block

时间窗: Observation of motor and sensory block after spinal anaesthesia in lower segment caesarean section every 5 minutes upto 10 minutes then every 10 minutes upto end of surgery

•post operative duration of first rescue analgesia demand

时间窗: Observation of motor and sensory block after spinal anaesthesia in lower segment caesarean section every 5 minutes upto 10 minutes then every 10 minutes upto end of surgery

次要结局

  • Hemodynamic stability after giving spinal anaesthesia in lower segment caesarean section(Heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, oxygen saturation for every 5 min for 10 minutes then every 10 minutes upto end of surgery)

研究者

发起方
Bharati Vidyapeeth Deemed to be University medical college and research center
申办方类型
Research institution and hospital

研究点 (1)

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