Comparative Study of Manual Infusion with Target Controlled Infusion for induction with Propofol in Patients Posted for Surgeries Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Dose of propofol needed for induction by manual infusion and Target Controlled Infusion
研究概览
简要总结
COMPARATIVE STUDY OF MANUAL INFUSION WITH TARGET CONTROLLED INFUSION FOR INDUCTION WITH PROPOFOL IN PATIENTS POSTED FOR SURGERIES UNDER GENERAL ANAESTHESIA
Patients who meet the inclusion and exclusion criteria will be randomised into 2 groups
T group – patient receiving propofol through target-controlled infusion for induction
M group – patient receiving propofol through manual controlled infusion for induction
On the previous day of surgery, all the patients will have pre anaesthetic evaluation done
Patients’ parts are prepared for surgery and will be shifted to operation theatre on the day of surgery. Under all aseptic precautions 18-gauge intravenous cannula will be secured and started with maintenance iv fluids. Patient will be connected to multipara monitor inside the operation theatre. Baseline heart rate, systolic and diastolic blood pressure, mean arterial pressure, oxygen saturation and Electrocardiogram will be recorded.
Bispectral index (BIS) monitoring will be connected to all the patients.
The B BRAUN system, which can deliver propofol by both manual controlled or target controlled infusion will be used for both M and T group, thus blinding the patients. The infusion machine will be covered with opaque cloth by the researcher. A second anesthetist who is collecting the data will not be present during randomisation and induction of anesthesia and he/she is also unaware of which infusion system is running.
In the T group, anesthesia is induced using TCI based on Schnider pharmacokinetic model by targeting a propofol plasma concentration of 4 mcg/ml at a rate of 1200 ml/hr until induction is achieved.
For the M group, Anesthesia is induced with bolus dose of propofol using B BRAUN medical infusion pump at an initial dose 2 mg/kg propofol with the same rate limitation of 1200 ml/hr.
Induction time is considered as the period between the initiation of infusion dose of the drug and when the BIS is decreased to less than 60.
The dose which will be requiring for achieving induction in the both the groups will be noted.
Once this is done all parameters will be statistically analysed.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists physical status grade I and grade II
- •Elective OT cases under general anaesthesia.
排除标准
- •Allergic to the study drug- Propofol
- •History of Asthma and Chronic obstructive pulmonary disease
- •History of any neurological disorder
- •History of Cardiopulmonary disease
- •Pregnant and lactating females
- •Difficult airway or difficult ventilation or difficult laryngoscopy.
结局指标
主要结局
Dose of propofol needed for induction by manual infusion and Target Controlled Infusion
时间窗: Frequency
次要结局
- Hemodynamic variability in both the groups(Frequency)
研究者
Dr Pavan V
Kodagu Institute of Medical Sciences