跳至主要内容
临床试验/CTRI/2020/02/023157
CTRI/2020/02/023157已完成不适用

Randomised double blinded comparative study of the effects of Intravenous lignocaine infusion and Caudal Bupivacaine in pediatric laparoscopic surgeries.

RAINBOW CHILDRENS HOSPITAL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Total fentanyl requirement intraoperatively and postoperatively and time to first rescue analgesia from the time of extubation

研究概览

简要总结

The study aims to compare the efficacy of intravenous lignocaine  given as 1.5 mg/kg bolus over 5 minutes followed by 1.5 mg/kg/hour infusion, with caudal bupivacaine 2.5 mg/kg prepared to 1.2 ml/kg, in 100 pediatric patients in the age group of 6 months to 6 years, undergoing laparoscopic abdominal surgeries with 50 patients in each group allocated randomly. The total intravenous fentanyl requirement both intraoperatively and postoperatively, time to first rescue analgesia after extubation, heart rate, systolic and diastolic blood pressure at various time points, pediatric anaesthesia emergence delirium score and FLACC Pain score in the postoperative period will be noted to compare the effects.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
6.00 Month(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • AMERICAN SOCIETY OF ANAESTHESIOLOGISTS GRADE 1 AND 2 CHILDREN LAPAROSCOPIC ABDOMINAL SURGERIES WEIGHING 10- 20 KILOGRAMS.

排除标准

  • HISTORY OF ALLERGY TO LOCAL ANAESTHETICS HISTORY OF SEIZURES HISTORY OF CARDIAC DISEASES.

结局指标

主要结局

Total fentanyl requirement intraoperatively and postoperatively and time to first rescue analgesia from the time of extubation

时间窗: T Extubation-at extubation total fentanyl used | T postoperative 2 hours- total fentanyl used postoperatively in 2 hours | T rescue- Time from extubation to first rescue analgesia

次要结局

  • Heart rate, Systolic blood pressure and Diastolic blood pressure(T0 (baseline), T1 (at the time of port insertion), Tpeak (maximum reading during the procedure), T2 (at extubation), T3(postoperative- 0 min), T4(postoperative- 5 min), T5(postoperative-15 min), T6(postoperative- 30 min), T7( postoperative- 1 hour), T8(postoperative- 2 hour))
  • Pediatric anaesthesia Emergence delirium score and Face,Legs,Activity,Cry Consolability FLACC pain scale(At awakening,At postoperative 30 minutes, 1 hour and 2 hour)

研究者

申办方类型
Other [ACADEMIC STUDY]

研究点 (1)

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