跳至主要内容
临床试验/CTRI/2025/08/092673
CTRI/2025/08/092673尚未招募2/3 期

Comparison of fast propofol bolus injection with conventional propofol & sevoflurane administration during anaesthesia induction for ease and proper placement of proseal lma in paediatric patients undergoing elective surgery

ABVIMS and Dr.Ram Manohar Lohia Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To assess ease of PLMA insertion in all the patients.

研究概览

简要总结

This study aims to compare the fast bolus propofol injection anaesthesia with conventionally administeredpropofol sevoflurane anaesthesia induction for ease and proper placementof Proseal LMA in pediatrics patients undergoing elective surgery. Group A will receive fast bolus propofol injection whereas Group B will receive conventional propofol injection followed by sevoflurane.

Pre Anaesthetically, all patients will undergo medical evaluation,consent is obtained and they are kept NPO 6 to 8 hours before sugery .

Pre Operatively, baseline vitals will be recorded . Premedication includes atropine, midazolam, fentanyl, and lignocaine.

Intra Operatively, oxygen  will be administered and all monitors will be attached . Group A receives rapid IV bolus propofol. PLMA  inserted 30 sec after loss of reflexes. Group B receives slower propofol injection along with  sevoflurane and then PLMA inserted.

PLMA insertion is judged based on ease, number of attempts and adequacy of ventilation. Failed insertion after 3 attempts lead to exclusion and ETT intubation. Hemodynamic parameters and complications are recorded.

The study concluded after successfil PLMA placement, ater wihich surgery proceeds under standard general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • ASA –I/II Elective surgery patients.

排除标准

  • Known patients of CVS, CNS & Respiratory Disorders.
  • Congenital birth defects Allergic to anaesthesia drugs.
  • Any airway obstruction like tumor .
  • Airway/oral surgery.

结局指标

主要结局

To assess ease of PLMA insertion in all the patients.

时间窗: 5 min after induction of anaesthesia

scoring system having components

时间窗: 5 min after induction of anaesthesia

1.Jaw opening

时间窗: 5 min after induction of anaesthesia

2.Ease of insertion

时间窗: 5 min after induction of anaesthesia

3.Coughing

时间窗: 5 min after induction of anaesthesia

4.Patients movements

时间窗: 5 min after induction of anaesthesia

5.Laryngospasm

时间窗: 5 min after induction of anaesthesia

6.Gagging

时间窗: 5 min after induction of anaesthesia

次要结局

  • Tidal Volume (Inspired & expired) & NG tube insertion(at 1min, 2 min, 3 min , 4 min 5min after PLMA insertion)
  • Vitals (HR , MBP, SpO2)(at 1min, 2 min, 3 min , 4 min 5min after PLMA insertion)
  • Number of attempts taken(till 5 minutes after induction of anaesthesia)
  • Injury- if any(5 min after PLMA insertion)

研究者

发起方
ABVIMS and Dr.Ram Manohar Lohia Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

SHIVANI

ABVIMS and Dr.Ram Manohar Lohia Hospital, New Delhi

研究点 (1)

Loading locations...

相似试验