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临床试验/CTRI/2024/02/062834
CTRI/2024/02/062834尚未招募4 期

Comparison of Total Intravenous Anaesthesia (TIVA)versus Inhalational Anaesthesia during elective spine surgery –A randomized controlled study

AIIMS raipur1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年2月28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
52
试验地点
1
主要终点
To compare recovery from anesthesia assessed by time to response to eye opening in minutes , time to obey verbal commands, time to extubation in minutes, modified aldrete score

研究概览

简要总结

Sevoflurane,an  inhalational anesthetic agent  offer advantages such as stable intraoperative hemodynamic course and rapid emergence from anesthesia. .It has have very low blood/gas partition coefficient (0.7), which offers rapid induction and emergence from anesthesia. Hence, it was deemed  suitable for spine surgeries.

Intravenous anesthetic propofol, according to its pharmacokinetic profile, is the mainstay for total intravenous anesthesia (TIVA); it has rapid onset and offset with fewer side effects, particularly postoperative nausea and vomiting (PONV).  Propofol has long been considered a nonanalgesic intravenous hypnotic. In human volunteers, propofol at a hypnotic dose of 3.5 mcg/ml decreased pain-related regional blood flow to the thalamus and anterior cingulate cortex.   It was found to  significantly decrease pain scores by 40% and areas of hyperalgesia and allodynia in human volunteers.Propofol’s preferential binding to the HCN1 pacemaker channels further reinforces its anti-hyperalgesic effect. Moreover, the anti-inflammatory effects of propofol have been shown both in vitro[9] and in human studies[and they may be responsible for propofol role in postoperative analgesia. Propofol-based anesthesia has been shown to be associated with reduced postoperative pain compared with volatile anesthesia, whereas other studies have reported no evidence of the superiority of propofol.A recent meta-analysis comparing postoperative pain between inhalational and propofol anesthesia showed no significant differences (P value of .04) probably due to substantial heterogeneity among studies.

The aim of this prospective study is to evaluate the recovery parameters of propofol-fentanyl based TIVA compared to inhalational anesthesia in  spine surgery.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective spine surgery American Society of Anesthesiologists (ASA) physical status 1 and 2.

排除标准

  • Patient’s refusal History of Drug Allergy There was difficulty in the assessment of postoperative pain postoperative mechanical ventilation Uncontrolled hypertension or diabetes mellitus Chronic obstructive pulmonary disease Hepatic and renal dysfunction Pregnancy OR Lactation When the patients required a second operation.
  • BMI more than 35.

结局指标

主要结局

To compare recovery from anesthesia assessed by time to response to eye opening in minutes , time to obey verbal commands, time to extubation in minutes, modified aldrete score

时间窗: during intra op period and posto op period

次要结局

  • 1. To compare opioid consumption .(2. To compare adverse events during emergence, such as hemodynamic changes , pain (VAS score),PONV, shivering ,agitation and convulsion.)

研究者

发起方
AIIMS raipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Prekshit onkar gudadhe

All India Institute Of Medical Sciences, Raipur

研究点 (1)

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