| 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
|
|
|
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
|
|
|
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
|
|
|
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. |