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临床试验/CTRI/2024/07/069891
CTRI/2024/07/069891尚未招募不适用

Comparative study to evaluate efficacy of intravenous Ketamine and Tramadol for prevention of shivering in patients undergoing caesarean section under spinal anaesthesia

Pt B D Sharma University of Health Sciences PGIMSRohtakHaryana1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月15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
120
试验地点
1
主要终点
Prevention of shivering

研究概览

简要总结

A prospective , Randomized and double blinded study will be conducted in healthy pregnant women,of 18 - 40 years of age without any comorbid conditions requiring caesarean section under spinal anaesthesia. Patient with refusal to consent, Patients with history of hypersensitivity to study drugs ,history of cardiovascular diseases, hypertension , pregnancy induced hypertension(PIH),Eclampsia, Antepartum Hemorrhage, intake of any antipsychotic medications. Patients who will develop shivering prior to study drugs. Failure of spinal anaesthesia and patient requiring general anaesthesia or sedation or and any other major intraoperative complications .will be excluded from study. Patient will be randomly allocated into one of the three groups ,according to computer generated list Group (K1)will receive 0.25mg/kg Ketamine, Group (K2) will receive 0.5mg/kg Ketamine, Group (T) will receive 0.5 mg/kg Tramadol. Patients will be prepared and given spinal anaesthesia and after delivery of baby the study drugs will be given. Patients heart rate ,blood pressure, oxygen saturation ,temperature, sedation score and shivering grading will be recorded, every 5 minutes intraoperatively and every 10 minutes postoperatively over an hour .Data will be analysed using appropriate statistical methods.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 120 Healthy pregnant women aged 18-40 years, American Society of Anesthesiologists (ASA) physical status II, with fullterm singleton pregnany requiring caesarean section under spinal anaesthesia.

排除标准

  • Patients Refuse to give consent,Any contraindications and hypersensitivity to the study drugs,History of cardiovascular diseases, hypertension, Pregnancy Induced hypertension (PIH),Eclampsia, Antepartum hemorrhage, intake of antipsychotic medications,Patients who will develop shivering prior to administration of study drugs,Failure of spinal anaesthesia and patients requiring general anaesthesia or sedation or any other major intraoperative complications.

结局指标

主要结局

Prevention of shivering

时间窗: Intraoperatively every 5 minutes and post operatively every 10 minutes

次要结局

  • To prevent perioperative complications if any like nausea,vomiting,sedation,hypotension,bradycardia(Intraoperatively every 5 minutes and postoperatively every 10 minutes)

研究者

发起方
Pt B D Sharma University of Health Sciences PGIMSRohtakHaryana
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sudha Puhal

Pt.B.D.Sharma PGIMS Rohtak

研究点 (1)

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