CTRI/2026/02/104713尚未招募1 期
Comparing Induction Time Of Standard Vs Diluted Concentration Of Propofol In Patients Undergoing Laproscopic Tubal Ligation A Randomized Controlled Study
DrBabasaheb ambedkar medical college and hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2026年3月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
研究概览
简要总结
- Limited data exist comparing 1% vs 0.5% propofol for induction characteristics & haemodynamic responses during laparoscopic procedures
- Many studies are underpowered for induction time, haemodynamic stability, recovery time, and adverse events, focusing mainly on injection pain. • Furthermore,there is little information on use of titrated doses of propofol for induction characteristics
- Methodological heterogeneity exists regarding pain on injection of propofol—such as differences in injection site, cannula size, premedication, and infusion rate—confounds interpretation, making it unclear whether observed benefits are due to dilution itself or to altered administration technique
- Hence, a well-designed randomized controlled study directly comparing 1% vs 0.5% propofol in laparoscopic tubal ligation is warranted to provide robust evidence for clinical practice.
- Study Area:
- The study will be conducted in the operation theatre complex, Department of Anaesthesiology & Critical care at Dr. Baba Saheb Ambedkar Medical college and Hospital, Sector-6, Rohini, Delhi.
- Primary Objective
- To compare the induction time of 1% versus 0.5% propofol during induction of anaesthesia in laparoscopic tubal ligation.
- Secondary Objectives
- To compare hemodynamic parameters( changes in HR, SBP, DBP, and MAP before induction,at the end of induction & 5 minutes after induction) and incidence of apnea
- To compare the total propofol dose required for induction
- To compare pain on injection among the two groups using a Visual Analogue Scale (VAS 010) measured at the time of infusion.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patients aged 18-45 years.
- •2.Scheduled for laparoscopic tubal ligation under general anaesthesia.
- •3.ASA physical status I or II.
- •4.Body Mass Index (BMI) 18–30 kg/m².
排除标准
- •1.Known allergy to propofol, egg, or soy products.
- •2.Cardiovascular disease: uncontrolled hypertension, arrhythmias, ischemic heart disease.
- •3.Respiratory disease: severe asthma, COPD.
- •4.Hepatic or renal dysfunction.
- •5.History of difficult airway or anticipated airway problems.
- •6.Patients on medications that interfere with anesthetic drugs (e.g., chronic sedatives, anticonvulsants).
- •7.Any neurological or psychiatric disorder affecting assessment of consciousness.
研究者
Dr Dhanave Chakradhar Bhaskar
Dr.Baba Saheb Ambedkar Medical Collage And Hospital,Rohini,New Delhi
研究点 (1)
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