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临床试验/CTRI/2024/10/074828
CTRI/2024/10/074828尚未招募不适用

A Randomised controlled single blinded trial to compare Opioid free anesthesia and Opioid based anesthesia in patients undergoing elective craniotomy for Supratentorial lesion

Dr Bishnupriya Mohapatra1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To compare duration to first rescue analgesic requirement in post operative period in

研究概览

简要总结

this study was formulated to assess the utility and efficacy of opioid

based and opioid free anesthesia in patients undergoing craniotomy for supratentorial lesions . Aim of the study is to compare the opioid free anesthesia technique to conventional opioid based

technique in patients undergoing supratentorial craniotomy in patients for rescue analgesic

requirement and pain scores

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

  • Patient belonging to ASA I,II,III Patients with pre operative GCS more than 14 Patient posted for elective supratentorial lesion.

排除标准

  • Patient posted for emergency craniotomy surgeries 3) Patient belonging to ASA IV and above 4) Patient with bradycardia (Heart rate <60 beats per minute) 5) Patient refusing to consent 6) Patient with chronic pain or on opioid medication 7) Patient with known allergy to study drugs 8) Patients with difficult airway.

结局指标

主要结局

To compare duration to first rescue analgesic requirement in post operative period in

时间窗: To compare duration to first rescue analgesic requirement in post operative period in | patients undergoing supratentorial craniotomy receiving opioid based anesthesia and | those receiving opioid free anesthesia

patients undergoing supratentorial craniotomy receiving opioid based anesthesia and

时间窗: To compare duration to first rescue analgesic requirement in post operative period in | patients undergoing supratentorial craniotomy receiving opioid based anesthesia and | those receiving opioid free anesthesia

those receiving opioid free anesthesia

时间窗: To compare duration to first rescue analgesic requirement in post operative period in | patients undergoing supratentorial craniotomy receiving opioid based anesthesia and | those receiving opioid free anesthesia

次要结局

  • post operative pain at 1,2,4,6,12 and 24 hours post operatively.(at 1,2,4,6,12 and 24 hours post operatively.)
  • total dose of rescue analgesic(post operatively.)
  • incidence of side effects like bradycardia, tachycardia, hypotension ,(hypertension, post operative nausea vomiting , pruritus, respiratory depression)
  • total number of propofol bolus(intra operatively.)
  • compare quality of recovery (QoR- 15) score(at 1, 6 ,12 , 24 hours post operatively)

研究者

发起方
Dr Bishnupriya Mohapatra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bishnupriya Mohapatra

AIIMS Rishikesh

研究点 (1)

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