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临床试验/CTRI/2025/11/096911
CTRI/2025/11/096911尚未招募4 期

fast track anaesthesia with remifentanyl : A Prospective Study in Ambulatory Surgeries

GCS MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月18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
100
试验地点
1
主要终点
To evaluate hemodynamic stability of remifentanil

研究概览

简要总结

Type: Prospective randomized controlled trial (RCT)

Sample size ..100 or time duration based whatever is greater

Participants: A total of 100 adult patients (ASA I–II) scheduled

for elective ambulatory surgeries,

Randomization: Patients were randomly assigned to two

groups

Remifentanil Group (Group R n=50): Received remifentanil infusion.

Fentanyl Group (Group F n = 50): Received fentanyl infusion.

INCLUDED Day-care unit or ambulatory surgery center performing procedures

such as:

Upper gastrointestinal endoscopy

Colonoscopy

Minor general surgery (e.g., hernia repair, cyst excision)

Gynecological procedures (e.g., D&C, hysteroscopy)

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor 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

  • Willing to give consent ASA Physical Status I or II Undergoing elective ambulatory surgery.

排除标准

  • Known opioid allergy ASA 3,4 Severe cardiopulmonary disease Pregnancy.

结局指标

主要结局

To evaluate hemodynamic stability of remifentanil

时间窗: at start of procedure, every 5,10,15 mins and then every 30 mins until end of procedure

To evaluate analgesia and sedation of remifentanil patients

时间窗: at start of procedure, every 5,10,15 mins and then every 30 mins until end of procedure

undergoing ambulatory surgeries

时间窗: at start of procedure, every 5,10,15 mins and then every 30 mins until end of procedure

To assess the time to recovery and discharge readiness following

时间窗: at start of procedure, every 5,10,15 mins and then every 30 mins until end of procedure

remifentanil-

时间窗: at start of procedure, every 5,10,15 mins and then every 30 mins until end of procedure

次要结局

  • To compare patient and surgeon satisfaction scores with remifentanil(versus fentanyl)

研究者

发起方
GCS MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Divya Kheskani

GCS Medical college Hospital and Research Centre Ahmedabad

研究点 (1)

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