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临床试验/CTRI/2025/06/088002
CTRI/2025/06/088002尚未招募不适用

A PROSPECTIVE OBSERVATIONAL STUDY TO COMPARE QUALITY OF ANAESTHESIA, DOSE, AND RECOVERY WITH TARGET VERSUS MANUAL CONTROLLED INFUSION OF PROPOFOL FOR INFRAUMBILICAL SURGERY IN CHILDREN.

LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月5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
50
试验地点
1
主要终点
To compare TCI versus MCI propofol with respect to the

研究概览

简要总结

Propofol is an intravenous anesthetic agent used for both the induction and maintenance of general anaesthesia. The aim when using propofol in this way is to infuse it at a suitable rate, with additional boluses as needed, to achieve an effective blood concentration that corresponds to the level of surgical stimulation. Various methods, such as Manual Controlled Infusion (MCI) and Target Controlled Infusion (TCI), have been suggested for delivering propofol in Total Intravenous Anaesthesia (TIVA).

MCI involves an anaesthesiologist manually operating the infusion pump by setting a flow rate based on the prescribed dose and the patient’s condition. The McFarlan method is commonly used, involving an induction dose of 2.5 mg/kg followed by maintenance doses that vary over time: 15 mg/kg/hr for the first 15 minutes, 13 mg/kg/hr from 15-30 minutes, 11 mg/kg/hr from 30 minutes to 1 hour, 10 mg/kg/hr from 1-2 hours, and 9 mg/kg/hr for 2-4 hours

TCI uses a theoretical approach described by Kruger-Thiemer to achieve and maintain a steady-state concentration of a drug with pharmacokinetics described by a multicompartmental model. the Pedfusor model is used to maintain a Cp value of 4-8 mcg/ml initially, followed by adjustments according to the needs of the surgery and response to stimuli.

In this study children undergoing infraumbilical surgeries who receive general anaesthesia with caudal epidural/regional anaesthesia will be observed. Nil by Mouth (NBM) status assessed. The child is taken to the operating room (OT). Standard ASA monitors are attached, and an initial reading of all parameters is noted. Fentanyl (2 mcg/kg) is administered through a patent IV line. After tying a tourniquet proximal to the IV-line, 1 mg/kg of preservative-free lignocaine is given. The tourniquet is then released. Anaesthesia is induced 5 minutes after administering fentanyl using the intravenous induction agent propofol, either through a TCI Pedfusor model or an MCI pump.

No neuromuscular blocking agent is given. When the appropriate depth of anaesthesia is achieved, a supraglottic airway device (SGAD) is inserted, and any response to the SGAD is noted. The patient is then connected to assisted mode ventilation with appropriate fresh gas flow (O2 + air), a tidal volume of 5-7 ml/kg, and a respiratory rate according to age. Age-appropriate regional block is administered following all aseptic precautions. Infusions are stopped, and the child is allowed to remove the SGAD.

Parameters to be assessed:

• Preoperative vitals (HR, SBP, DBP, SPO2)

• Post induction vitals (HR, SBP, DBP, SPO2)

• Total Propofol dose in mg/kg/hr including the initial bolus given in MCI Induction

• Quality of anaesthesia (number of boluses given and no of times the infusion rate has been changed as a result of patient’s response to stimuli and hemodynamic changes)

• Recovery

• Ease of usage as per Anaesthesiologist (Excellent, good, fair poor)

• Satisfaction of quality of anaesthesia as per surgeons (excellent, good, fair, poor)

• Need for additional inhalational or intravenous anaesthesia agent

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • All children between the age 3 years to 12 years, weight between 5-61 kg receiving either TCI (pedfusor) or MCI propofol anesthesia (MacFarlan protocol) for infraumbilical surgery with supraglottic airway device and caudal epidural or regional block.

排除标准

  • 1.Those cases who do not have intravenous access before the surgery and require inhalational induction.
  • 2.Those who need oral premedication prior to induction 3.TCI by any protocol other than Pedfusor 4.MCI by any protocol other than MacFarlan 5.Lack of parental consent.

结局指标

主要结局

To compare TCI versus MCI propofol with respect to the

时间窗: Baseline post procedure

1.Quality of anaesthesia measured by frequency of boluses of propofol needed and number of times infusion pump setting has to be changed in response to surgical stimulus and hemodynamic changes

时间窗: Baseline post procedure

2.Ease of use by Anaesthetist

时间窗: Baseline post procedure

3.Satisfaction by the surgeons

时间窗: Baseline post procedure

次要结局

  • To assess and compare TCI versus MCI propofol infusion in terms of:(1. Total dose requirement)

研究者

发起方
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

SAKTHI NARENDRAN

LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL

研究点 (1)

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