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CTRI Number  CTRI/2025/06/088823 [Registered on: 13/06/2025] Trial Registered Prospectively
Last Modified On: 12/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Medications Dexmedetomidine and Tramadol to Control Shivering After Spinal Anesthesia in Cesarean Deliveries" 
Scientific Title of Study   Comparison of efficacy of IV Dexmedetomidine and IV Tramadol for management of post spinal shivering in LSCS surgeries. A prospective randomized double blind clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mili Mungalpara 
Designation  Second Year Postgraduate Anesthesia Resident 
Affiliation  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE 
Address  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE JAIL ROAD (INDIRA AVENUE)
ANANDPURA
Vadodara
GUJARAT
390001
India 
Phone  8866264602  
Fax    
Email  milimungalpara5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamta Patel 
Designation  Associate Professor 
Affiliation  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE 
Address  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE JAIL ROAD (INDIRA AVENUE)
ANANDPURA
Vadodara
GUJARAT
390001
India 
Phone  9825453024  
Fax    
Email  mgpatel111@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Mamta Patel 
Designation  Associate Professor 
Affiliation  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE 
Address  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE JAIL ROAD (INDIRA AVENUE)
ANANDPURA
Vadodara
GUJARAT
390001
India 
Phone  9825453024  
Fax    
Email  mgpatel111@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE 
Address  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE JAIL ROAD (INDIRA AVENUE) ANANDPURA VADODARA GUJARAT 390001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mili Mungalpara  SIR SAYAJIRAO GENERAL HOSPIITAL AND BARODA MEDICAL COLLEGE  SIR SAYAJIRAO GENERAL HOSPITAL AND BARODA MEDICAL COLLEGE JAIL ROAD (INDIRA AVENUE) ANANDPURA
Vadodara
GUJARAT 		 8866264602

milimungalpara5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research (IECBHR) Medical College and SSG Hospital, Baroda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cessation of shivering using IV Dexmedetomidine  After preanesthetic evaluation and written informed consent patients meeting inclusion criteria will be selected. Spinal anesthesia will be administered at the L3-L4 intervertebral spaces using 2ML, 0.5% Bupivacaine. Patients will be divided randomly in 2 groups. Upon the onset of shivering of grade II severity, defined according to a standardized grading scale. Patients in Group D will receive intravenous Dexmedetomidine at a dose of 0.5 mcg/kg diluted to a concentration of 1 mcg/mL which will be administered over 10 minutes. 
Comparator Agent  Cessation of shivering using IV Tramadol  After preanesthetic evaluation and written informed consent patients meeting inclusion criteria will be selected. Spinal anesthesia will be administered at the L3-L4 intervertebral spaces using 2ML, 0.5% Bupivacaine. Patients will be divided randomly in 2 groups. Upon the onset of shivering of grade II severity, defined according to a standardized grading scale patients in Group T will receive intravenous Tramadol at a dose of 0.5 mg/kg diluted to a concentration of 1 mg/mL administered over 10 minutes. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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
 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Time of cessation of shivering
 		 till 120 minutes after giving spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
Onset of shivering
Severity of shivering
Recurrence of shivering
hemodynamic stability
Any other complication 		 till 120 minutes after giving spinal anaesthesia 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [milimungalpara5@gmail.com].

  6. For how long will this data be available start date provided 21-06-2026 and end date provided 21-06-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

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

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

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

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


 
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