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临床试验/CTRI/2019/03/018299
CTRI/2019/03/018299已完成不适用

Comparison of Isobaric Ropivacaine (0.75%) with Buprenorphine and Isobaric Levobupivacaine (0.5%) with Buprenorphine in patients undergoing surgeries under Subarachnoid block: A Prospective Randomized Double Blind Study

Aniruth Geethchand1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年3月28日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
compare the efficacy of Isobaric Ropivacaine(0.75%) with Buprenorphine 0.2 ml(60µg) and Isobaric Levobupivacaine (0.5%)with Buprenorphine 0.2ml(60µg) in patients undergoing surgeries under Subarachnoid block.

研究概览

简要总结

The purpose of my study is to compare the efficacy of isobaric ropivacaine with buprenorphine and isobaric levobupivacaine with buprenorphine in patients who undergo surgeries under spinal anaesthesia in terms of

Onset and duration of sensory blockade.

Onset and duration of motor blockade.

Hemodynamic stability between two groups.

Drug having the least side effects.

Drug that can be used for early ambulation.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Age group between 18 to 65 years.
  • 2.American Society of Anesthesiologist (ASA) Grade I and II.
  • 3.Lower abdominal surgeries 4.Lower limb orthopaedics surgeries 5.Both Elective and Emergency procedures 6.Duration of surgery ≥ 60 minutes.

排除标准

  • Patients not willing for regional anesthesia.
  • Patients not willing to be in the study group.
  • Pregnant patients.
  • Known allergy to the study drugs.
  • Patients with Peripheral neuropathy.

结局指标

主要结局

compare the efficacy of Isobaric Ropivacaine(0.75%) with Buprenorphine 0.2 ml(60µg) and Isobaric Levobupivacaine (0.5%)with Buprenorphine 0.2ml(60µg) in patients undergoing surgeries under Subarachnoid block.

时间窗: Onset of sensory block is defined as the time taken to achieve loss of temperature sensation at T8 dermatome using cold saline cotton swab. It will be assessed using Gromley and Hill 1996. | Onset of motor block is defined as the time taken to achieve complete motor block which is graded according to modified Bromage scale | Two segment regression of sensory block and motor regression time also be recorded.

次要结局

  • To compare onset and duration of sensory blockade.(To compare onset and duration of motor blockade.)

研究者

发起方
Aniruth Geethchand
申办方类型
Research institution and hospital

研究点 (1)

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