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CTRI Number  CTRI/2025/12/099458 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two warming methods to prevent low body temperature during laparoscopic surgery 
Scientific Title of Study   Prospective comparative study to know effectiveness of pre-warming and co-warming in prevention of intraoperative hypothermia in laparoscopic surgeries 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hasitha Kari 
Designation  Junior Resident  
Affiliation  KAHER’s Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Anesthesiology, KAHER’s Jawaharlal Nehru Medical College, KAHER, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9491915043  
Fax    
Email  hasithakari.hk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahantesh Mudakanagoudar 
Designation  Professor 
Affiliation  KAHER’s Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Anesthesiology, KAHER’s Jawaharlal Nehru Medical College, KAHER, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  78291 64500  
Fax    
Email  drmontygoudar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Hasitha Kari 
Designation  Junior Resident  
Affiliation  KAHER’s Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Anesthesiology, KAHER’s Jawaharlal Nehru Medical College, KAHER, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9491915043  
Fax    
Email  hasithakari.hk@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Hasitha Kari  
Address  Jawaharlal Nehru Medical College, Belagavi 
Type of Sponsor  Private 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 Hasitha Kari  KLEs Dr PRABHAKAR kore medical hospital and research center  2nd floor, Department of Anaesthesiology
Belgaum
KARNATAKA 		 9491915043

hasithakari.hk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T68||Hypothermia, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cowarming only  Patients in Group B will receive only intra-operative co-warming using a forced-air warming device set at 40°C. No pre-warming will be done. Intravenous fluids will be pre-warmed and operating room temperature maintained at 21–22°C. 
Intervention  Prewarming + Cowarming  Patients in Group A will receive pre-warming for 30 minutes before induction using a forced-air warming device set at 40°C, followed by continuous co-warming intra-operatively. Intravenous fluids will be pre-warmed prior to administration. Operating room temperature will be maintained at 21–22°C. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients between ages 18-65 years of either gender undergoing laparoscopic surgery.
Patients of ASA Grade 1-3.
Anaesthesia lasting for more than 2 hours duration. 
 
ExclusionCriteria 
Details  Patients with pre-existing hypotherm
Patients with pre-existing hyperthermia
Patients with thyroid disorders
Patients with Peripheral Vascular Disease
Patients with body mass indices (BMI) above 31kg per meter square 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Core body temperature (°C)  Baseline, after induction, and every 20 minutes till end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Heart rate trends during surgery.

Blood pressure trends during surgery. 		 Baseline

After induction

Every 20 minutes intraoperatively 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   30/12/2025 
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="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 - NO
Brief Summary   This prospective randomized study aims to evaluate the effectiveness of pre-warming versus co-warming in preventing intraoperative hypothermia during elective laparoscopic surgeries under general anesthesia. Patients will be allocated to either pre-warming before induction or co-warming started immediately after induction and continued throughout surgery. Core temperature will be monitored at baseline, after induction, and every 20 minutes intraoperatively. The study seeks to determine which warming strategy better maintains normothermia and minimizes hypothermia-related intraoperative and early postoperative complications. 
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