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临床试验/CTRI/2025/10/096733
CTRI/2025/10/096733
尚未招募
2 期

Effect of intravenous ketamine infusion on obstetric quality of recovery score in patient undergoing cesarean delivery after spinal anesthesia: A randomized, triple-blinded, controlled trial

Soumita Biswas1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年11月15日最近更新:

概览

阶段
2 期
状态
尚未招募
发起方
Soumita Biswas
入组人数
142
试验地点
1
主要终点
Effect of intravenous ketamine infusion on obstetric quality of recovery score

概览

简要总结

This is a study measuring patient centered outcome to guide meaningful changes in obstetric anesthesia care. The obstetric quality of recovery score provides a holistic measure of patient reported recovery for mother undergoing cesarean delivery, comprising both psychological and functional outcomes. In this study we have planned to determine effectiveness of low dose ketamine infusion in patient receiving spinal anesthesia for lower uterine section.

Primary Objective is to compare OBS Q0R11 score in patient receiving low dose ketamine infusion vs control group at 24 hours time period point in post operative period.

Secondary Objective are hemodynamic parameter, post operative pain assessed by VAS score, sedation score, fetus evaluated by APGAR score, post operative nausea, vomiting, nystagmus, diplopia and hallucination, Ramsay sedation score, perioperative shivering.

Type of study is randomized, triple blind, prospective, controlled study.

Inclusion criteria comprises of full term female patient between 21 and 41 with ASA I, II, III.

Exclusion criteria comprises of twins and preterm birth, hypertensive and pre eclampsia patient, morbidly obese patient, spinal anesthesia contraindication because the patient refused, severe mitral and tricuspid stenosis and local infection

The patient would be equally randomized into two groups. One group will be given intravenous ketamine and the other group will be given intravenous saline. OBSQ0R11 scale at 24 hours in post operative will be seen

Sample size is 142.

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
21.00 Year(s) 至 41.00 Year(s)(—)
性别
Female

入选标准

  • Female patients and full term, between 21 and 41, with ASA I, II, III, and undergoing elective cesarean section.

排除标准

  • Twins and preterm birth 2) Hypertensive and pre-eclampsia patient 3) Morbidly obese patient 4) Spinal anesthesia contraindication because the patient refused, severe mitral or tricuspid stenosis and local infection.

结局指标

主要结局

Effect of intravenous ketamine infusion on obstetric quality of recovery score

时间窗: 24 hours

次要结局

  • Hemodynamic parameters (MAP and HR)(15 minutes, 30 minutes, 45 minutes, 60 minutes)
  • Ramsay Sedation Score(5 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes)
  • VAS Score(4 hours, 8 hours, 12 hours, 16 hours, 24 hours)
  • APGAR Score(1 minute, 5 minutes)

研究者

发起方
Soumita Biswas
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Soumita Biswas

Indira Gandhi Institute of Medical Sciences, Patna

研究点 (1)

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