| CTRI Number |
CTRI/2025/09/093981 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare if giving the intervention Pethidine along with warming measures during Caesarean section surgery under spinal anesthesia, helps reduce shivering better versus warming alone among the participants |
|
Scientific Title of Study
|
Efficacy of Pethidine along with intraoperative active warming in comparison with intraoperative active warming alone on incidence of shivering in caesarean section under spinal anaesthesia. A
randomised controlled trial. |
| 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 Ranjithkumar M |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Anaesthesiology & critical care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098030898 |
| Fax |
|
| Email |
ranjithkumar.kmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjithkumar M ( Guide) |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
2nd floor, IPD Building, Department of Anaesthesiology & critical care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098030898 |
| Fax |
|
| Email |
ranjithkumar.kmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjithkumar M |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Department of Anaesthesiology & critical care, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098030898 |
| Fax |
|
| Email |
ranjithkumar.kmc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Intramural fund Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Administrative block, Jawaharlal Institute of Postgraduate Medical Education and Research, dhanvantri nagar, Puducherry , pincode - 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ranjithkumar M |
Jawaharlal Institute of Postgraduate Medical Education and Research |
2nd floor, IPD BUILDING ,Department of Anaesthesiology & critical care, JIPMER , Dhanvantri nagar, Puducherry
Pondicherry
PONDICHERRY |
8098030898
ranjithkumar.kmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE- INTERVENTIONALSTUDIES |
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 |
| Comparator Agent |
Intraoperative active warming |
Warm iv fluids and air warmer will be given during intraoperative period |
| Intervention |
Pethidine drug and intraoperative active warming |
0.5mg per kg IV of drug Pethidine will be given to intervention group after cord clamping and warm iv fluids and air warmer will be given during intraoperative period |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
ASA PS 2 Obstetric
patients caesarean section under spinal anesthesia in
JIPMER |
|
| ExclusionCriteria |
| Details |
1) Parturients with grade 3,4 placenta previa,
abruptio placenta.
2) Parturients with fever.
3) Parturients allergic to narcotics |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Pethidine along with
intraoperative active warming in comparison with
intraoperative warming alone on the incidence of shivering
among the women’s undergoing caesarean section under
spinal anaesthesia. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the core temperature in pethidine with
intraoperative active warming group to only intraoperative
active warming group. |
2 years |
To determine the influence of these interventions on
maternal comfort temperature and general satisfaction. |
2 years |
To compare haemodynamic stability (blood pressure and
heart rate) in the intervention group. |
2 years |
To establish the incidence of complications of Pethidine,
including nausea, vomiting, headache or drowsiness. |
2 years |
To compare the requirement for rescue treatments for
shivering among various study groups. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized, parallel group , open label trial comparing the efficacy of Pethidine 0.5 mg/kg iv with intraoperative active warming to intraoperative active warming alone on incidence of shivering in caesarean section under spinal anaesthesia for 2 years in 280 Parturients. |