临床试验/CTRI/2025/09/093981

CTRI/2025/09/093981尚未招募Phase 3 4

Efficacy of Pethidine along with intraoperative active warming in comparison with intraoperative active warming alone on incidence of shivering in caesarean section under spinal anaesthesia. A randomised controlled trial.

Intramural fund Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点分布在 1 个国家目标入组 280 人开始时间: 2025年9月15日最近更新: 2025年8月29日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 280
试验地点: 1
主要终点: To assess the efficacy of Pethidine along with

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, parallel group , open label trial comparing the efficacy of Pethidine 0.5 mg/kg iv with

intraoperative active warming to intraoperative active warming alone on incidence of shivering in caesarean section under spinal anaesthesia for 2 years in 280 Parturients.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 21.00 Year(s) 至 49.00 Year(s)（—）
性别: Female

入选标准

•ASA PS 2 Obstetric patients caesarean section under spinal anesthesia in JIPMER.

排除标准

•Parturients with grade 3,4 placenta previa, abruptio placenta.
•Parturients with fever.
•Parturients allergic to narcotics.

结局指标

主要结局

To assess the efficacy of Pethidine along with

时间窗: 2 years

intraoperative active warming in comparison with

时间窗: 2 years

intraoperative warming alone on the incidence of shivering

时间窗: 2 years

among the women’s undergoing caesarean section under

时间窗: 2 years

spinal anaesthesia.

时间窗: 2 years

次要结局

To compare the core temperature in pethidine with(intraoperative active warming group to only intraoperative)
To determine the influence of these interventions on(maternal comfort temperature and general satisfaction.)
To compare haemodynamic stability (blood pressure and(heart rate) in the intervention group.)
To establish the incidence of complications of Pethidine,(including nausea, vomiting, headache or drowsiness.)
To compare the requirement for rescue treatments for(shivering among various study groups.)

研究者

发起方

Intramural fund Jawaharlal Institute of Postgraduate Medical Education and Research

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Ranjithkumar M

Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)

研究点 (1)

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