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Clinical Trials/CTRI/2024/07/069891
CTRI/2024/07/069891
Not yet recruiting
Not Applicable

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 site in 1 country120 target enrollmentStarted: July 15, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Pt B D Sharma University of Health Sciences PGIMSRohtakHaryana
Enrollment
120
Locations
1
Primary Endpoint
Prevention of shivering

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Prevention of shivering

Time Frame: Intraoperatively every 5 minutes and post operatively every 10 minutes

Secondary Outcomes

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

Investigators

Sponsor
Pt B D Sharma University of Health Sciences PGIMSRohtakHaryana
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Sudha Puhal

Pt.B.D.Sharma PGIMS Rohtak

Study Sites (1)

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