Comparing Two Medications Dexmedetomidine and Tramadol to Control Shivering After Spinal Anesthesia in Cesarean Deliveries"

Not yet recruiting

• Conditions: Encounter for cesarean delivery without indication,

• Registration Number: CTRI/2025/06/088823
• Lead Sponsor: SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE

Brief Summary

In this study we are comparing efficacy of IV Tramadol Vs IVDexmedetomidine for shivering in LSCS surgery.

146 patients fulfilling our inclusion and exclusion criteriawill be randomly divided in 2 groups. In each group there will be 73 patientswho will be undergoing LSCS surgery. In group D, patients will receive 0.5 micrograms/kgIV Dexmedetomidine. In group T, patients will 0.5 mg/kg IV Tramadol.

Our primary aim is to assess time of cessation of shiveringduring the operation till 120 minutes after spinal anaesthesia. And oursecondary aim is to assess the time of onset of shivering, severity ofshivering, recurrence of shivering, hemodynamic stability and any side effect.Severity of Shivering will be assessed using a five-point scale proposed byCrossley and Mahajan.

This study can help identify the most effective treatmentand safety profile of IV Dexmedetomidine and IV tramadol for the management ofpost-spinal shivering in pregnant patients undergoing LSCS.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Last Update Posted: 2025-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

• 1.Patients with shivering after giving spinal anesthesia in Caesarean section 2.Patients giving written and informed consent to participate in the study.
• 3.Age Group – 20 years to 45 years 4.American Society of Anesthesiologists (ASA) Grade II and III categories.

Exclusion Criteria

• 1.Patients Refusal 2.Patient having shivering before giving spinal anesthesia 3.Pre-existing heart disease, Respiratory diseases, Patient with coagulation disorder 4.
• Intraoperative Bradycardia (20% decrease in baseline pulse rate ) or Hypotension (20% decrease in baseline MAP) 5.Patients with allergy to study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time of cessation of shivering	till 120 minutes after giving spinal anaesthesia

Secondary Outcome Measures

Name	Time	Method
Onset of shivering	Severity of shivering

Trial Locations

Locations (1)

SIR SAYAJIRAO GENERAL HOSPIITAL AND BARODA MEDICAL COLLEGE; 🇮🇳 Vadodara, GUJARAT, India

SIR SAYAJIRAO GENERAL HOSPIITAL AND BARODA MEDICAL COLLEGE

🇮🇳Vadodara, GUJARAT, India

Dr Mili Mungalpara

Principal investigator

8866264602

milimungalpara5@gmail.com