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临床试验/CTRI/2025/03/082275
CTRI/2025/03/082275尚未招募4 期

The Efficacy of Fentanyl versus Buprenorphine as an adjuvant to intrathecal hyperbaric levobupivacaine in Cesarean section:A prospective Randomised comparative clinical Study

Mysore Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
.Onset and duration of sensory blockade

研究概览

简要总结

This study is a prospective randomized comparative clinical study comparing the efficacy of Fentanyl and Buprenorphine  when used as an adjuvant to 0.5% Hyperbaric levobupivacaine in patients coming for cesarean delivery where the effect of Fentanyl and Buprenorphine on sensory block ,motor block ,duration of analgesia is compared in Cheluvamba hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • All patients of age group 18 to 35 years, belonging to ASA grade 1 and 2 ,with height ranging from 150-180cms.,and weight ranging from 50-90kgs.
  • coming for cesarean delivery.

排除标准

  • .Patients with spinal deformity .Gestational age less than 36 weeks .Patients with medical and obstetric complication .Patients allergic to study drugs .Patients with local skin infections .Patients with impaired renal and liver function tests .Patients with coagulation disorder ,Patients not willing to give consent.

结局指标

主要结局

.Onset and duration of sensory blockade

时间窗: .Time of onset of sensory block at T10 | .Time of attaining maximum sensory blockade | .Time for two segment sensory regression | .Total duration of analgesia | .Time taken for maximum motor blockade.

.Maximum sensory blockade and time taken for it

时间窗: .Time of onset of sensory block at T10 | .Time of attaining maximum sensory blockade | .Time for two segment sensory regression | .Total duration of analgesia | .Time taken for maximum motor blockade.

.Time for two segment sensory regression

时间窗: .Time of onset of sensory block at T10 | .Time of attaining maximum sensory blockade | .Time for two segment sensory regression | .Total duration of analgesia | .Time taken for maximum motor blockade.

.Total duration of analgesia

时间窗: .Time of onset of sensory block at T10 | .Time of attaining maximum sensory blockade | .Time for two segment sensory regression | .Total duration of analgesia | .Time taken for maximum motor blockade.

.Onset and duration of motor blockade

时间窗: .Time of onset of sensory block at T10 | .Time of attaining maximum sensory blockade | .Time for two segment sensory regression | .Total duration of analgesia | .Time taken for maximum motor blockade.

.Quality of motor blockade and time taken for maximum motor blockade.

时间窗: .Time of onset of sensory block at T10 | .Time of attaining maximum sensory blockade | .Time for two segment sensory regression | .Total duration of analgesia | .Time taken for maximum motor blockade.

次要结局

  • .Hemodynamic parameters like HR,SBP,DBP,MAP(.Neonatal assessment using APGAR scoring)

研究者

发起方
Mysore Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nandakishor A Mane

MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE

研究点 (1)

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