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CTRI Number  CTRI/2025/11/098127 [Registered on: 26/11/2025] Trial Registered Prospectively
Last Modified On: 25/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A randomised double blinded study comparing intrathecal bupivacaine with fentanyl versus bupivacaine with intravenous ondansetron on perioperative shivering in cesarean section 
Scientific Title of Study   Effect of intrathecal bupivacaine plus fentanyl vs intrathecal bupivacaine plus intravenous Ondansetron on shivering in patients undergoing caesarean section under spinal anesthesia : A Randomised clinical study 
Trial Acronym  NL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Hidangmayum 
Designation  Post graduate trainee 
Affiliation  Regional institute of medical sciences,Imphal 
Address  Department of Anaesthesiology, Regional institute of medical sciences, Imphal, 795001, Manipur

Imphal West
MANIPUR
795001
India 
Phone  8794954612  
Fax    
Email  rahulhidng@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gojendra Rajkumar 
Designation  Professor & HOD 
Affiliation  Regional institute of medical sciences 
Address  Department of Anaesthesiology,Regional institute of medical sciences, Imphal

Imphal West
MANIPUR
795001
India 
Phone  9862824562  
Fax    
Email  gojendrar68@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gojendra Rajkumar 
Designation  Professor & HOD 
Affiliation  Regional institute of medical sciences 
Address  Department of anaesthesiology, Regional institute of medical sciences, Imphal,795001, Manipur

Imphal West
MANIPUR
795001
India 
Phone  9862824562  
Fax    
Email  gojendrar68@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Rahul Hidangmayum 
Address  Department of Anaesthesiology,Regional institute of medical sciences,Imphal, 795001,Manipur,India 
Type of Sponsor  Other [Self] 
 
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 Rahul Hidangmayum  Regional institute of medical sciences, Imphal   Department of Anaesthesiology
Imphal West
MANIPUR 
8794954612

rahulhidng@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board RIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intrathecal bupivacaine plus fentanyl  Patients receive spinal anesthesia with 2mL of 0.5% hyperbaric bupivacaine combined with intrathecal fentanyl (25 µg). No intravenous ondansetron is given. Instead, 4 mL intravenous normal saline bolus is administered to maintain blinding.Temperature charting will be done every 5minutes for 45minutes 
Comparator Agent  Intrathecal bupivacaine with intravenous Ondansetron   Patients receive spinal anesthesia with 2mL of 0.5% hyperbaric bupivacaine without any intrathecal opioid. Intravenous ondansetron (4 mg)bolus is administered immediately after spinal anesthesia. No intrathecal fentanyl is given. Temperature will be measured every 5minutes for 45 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients of American society of Anesthesiologist grade I or II, singleton pregnancy at term , elective caesarean section under spinal  
 
ExclusionCriteria 
Details  Known hypersensitivity to ondansetron or fentanyl,History of motion sickness or use of anti-emetics within the past 24 hours,Patients with diabetes, hypertension, thyroid disorder, or any cardiovascular, respiratory, renal, hepatic, or neurological disease, conversion to general anesthesia,Infection at the spinal injection site,Preoperative abnormal body temperature or febrile patients,Spinal deformity,Bleeding disorder  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence and severity of shivering following spinal anesthesia assessed using a validated shivering scale for 45 minutes  Incidence and severity of shivering following spinal anesthesia assessed using a validated shivering scale for every 5 minutes for 45 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="252"
Sample Size from India="252" 
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   Phase 4 
Date of First Enrollment (India)   08/12/2025 
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="4"
Days="8" 
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 - NO
Brief Summary  
Post spinal anaesthesia shivering is known to be a frequent complication and has a reported incidence of 40 to 70 percent. Shivering is defined as the involuntary and oscillatory muscular activity that increases the metabolic rate by two to three fold to maintain core temperature by increasing heat production.

This study will be a randomized clinical study to compare the efficacy of intravenous ondansetron and intrathecal fentanyl in evaluating temperature changes and shivering in patients undergoing elective lower segment caesarean sections under spinal anaesthesia.

A total of 252 patients aged 18 to 40 years of ASA physical status I and II undergoing elective lower segment caesarean section will be enrolled in the study. The patients will be divided into two groups of 126 each. The study drug will be prepared in a 5 mL syringe by an anaesthesiologist not directly involved in the study to maintain double blinding. Group F will receive intrathecal fentanyl along with 10 mg 2 mL of 0 point 5 percent hyperbaric bupivacaine and 4 mL intravenous normal saline. Group O will receive 4 mL 0 point 1 mg per kg intravenous ondansetron following intrathecal injection of 10 mg 2 mL of 0 point 5 percent hyperbaric bupivacaine. The operating room temperature will be maintained at an ambient temperature of around 24 to 26 degrees Celsius.

Vital parameters including temperature, blood pressure, heart rate, and SpO2 will be recorded preoperatively and intraoperatively. The time of onset of shivering, its grade, and the time of disappearance of shivering will be recorded. In case shivering is not controlled by the study drugs, 0 point 5 mg per kg of intravenous tramadol will be used as rescue therapy. The collected data will be analysed using appropriate statistical methods. Quantitative data will be analysed using the Student t test and qualitative data will be analysed using the Chi square test. A p value less than 0 point 05 will be considered statistically significant.
 
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