Spinal anaesthesia with hyperbaric bupivacaine and isobaric 1%-2chloroprocaine for short duration surgeries: Prospective randomized double blind comparative study

Gayatri Vidya parishad institute of health care and medical technology1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2018年1月5日最近更新: 2019年11月18日

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 60
试验地点: 1
主要终点: The duration of sensory and motor blockade.

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

This is a prospective randomized double blind study, to compare the efficacy and duration of blockade of two local anaesthetics, 1% isobaric 2-chloroprocaine and 0.5% hyperbaric bupivacaine for spinal anaesthesia in day care surgeries and short duration procedures lasting 60 minutes, compared in 60 patients over 6 months duration in below umbilicus elective surgeries of ASA grade I-III of ages 18 to 70. The secondary outcomes include peak level of blockade, time until ambulation and time to reach eligibility to discharge. It is to compare and provide a suitable alternative to low dose long acting local anaesthetics in spinal anaesthesia for ambulatory surgeries.

研究设计

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

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•ASA I-III, Surgical procedures less than 60minutes ( 1 hour) , elective surgeries, below umbilicus procedures (lower limb, ano-rectal, urological, gynecological surgeries).

排除标准

•patients with contraindications to spinal anaesthesia ( Platelet count < 75,000 , INR >1.5 , use of anti-coagulants, Spinal deformities,, sevre cardiac lesions) , age < 18years > 70years, surgeries lasting more than 60minutes,n patients under ASA IV, V, E, patients allergic or intolerant to local anaesthetic agent, patients who are not willing to be included in the study.

结局指标

主要结局

The duration of sensory and motor blockade.

时间窗: 5 minutes to 4 hours

次要结局

peak level of blockade, time until ambulation, time to reach eligibility criteria for discharge, complications like transient neurological symptoms (TNS)(5minutes to 12 hours)

研究者

发起方

Gayatri Vidya parishad institute of health care and medical technology

申办方类型

Private medical college

研究点 (1)

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