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临床试验/CTRI/2025/10/096512
CTRI/2025/10/096512尚未招募4 期

Remifentanil versus Fentanyl along with Autoflow ventilation in Laparoscopic surgery: A Randomized controlled trial

GCS Hospital1 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15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 see PIP haemodynamic status time to extubation post operative

研究概览

简要总结

To compare Remifentanil and AutoFlow Ventilation with standard

Fentanyl and Conventional Volume-Controlled ventilation in Laparoscopic

Surgeries.

A prospective, randomized, controlled trial

Written and informed consent will be obtained.

Patients of ASA Grade I & II posted for elective laparoscopic surgeries to be included & randomly

divided into two equal groups of 50 each.

Group A (n=50): Remifentanil i

AutoFlow ventilation mode

Group B (n=50) Fentanyl iv bolus 2mcg/Kg followed by infusion dose - 0.5 mcg/kg/hr

Conventional volume-controlled ventilation

研究设计

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

  • Age 18 to 60 years ASA grade I and II Elective Laparoscopic surgeries and BMI less than 35 Kg per meter square.

排除标准

  • BMI more than 35 Kg per meter square ASA grade III IV and V Emergency surgeries Pregnancy and Allergies to study drugs.

结局指标

主要结局

To see PIP haemodynamic status time to extubation post operative

时间窗: At Baseline 15min 30 min 45 min 60 min 90 min 120 min after induction of anaesthesia | At extubation

次要结局

  • To assess time of extubation post operative pain score and rescue analgesia requirement(Pain score at time of extubation 6 hour after extubation 12 hour and 24 hour after extubation analgesic requirement in 24 hours after surgery)

研究者

发起方
GCS Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Carolin Smita Kerketta

GCS Medical college Hospital and Research Centre Ahmedabad

研究点 (1)

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