| CTRI Number |
CTRI/2025/09/094896 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of pre-warming before surgery on preventing shivering and low temperature in patients having lower abdominal surgery. |
|
Scientific Title of Study
|
The Effect of Preoperative Warming in Preventing Hypothermia and Shivering in Patients Undergoing Lower Abdominal Surgery in a Tertiary Care Hospital |
| 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 Anushka Rai |
| Designation |
Post Graduate Student |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Post Graduate Student
Department of Anaesthesiology
Kodagu Institute of Medical Sciences
Kodagu
Karnataka
571201
India
Kodagu
KARNATAKA
571201
India |
| Phone |
9448770506 |
| Fax |
|
| Email |
anushkarai44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amitha S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Kodagu Institute of Medical Sciences
Kodagu
Karnataka
571201
India
Kodagu
KARNATAKA
571201
India |
| Phone |
7204175765 |
| Fax |
|
| Email |
dramithamahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitha S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Kodagu Institute of Medical Sciences
Kodagu
Karnataka
571201
India
KARNATAKA
571201
India |
| Phone |
7204175765 |
| Fax |
|
| Email |
dramithamahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kodagu institute of medical sciences , Madikeri 571201 India |
|
|
Primary Sponsor
|
| Name |
Kodagu Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Kodagu Institute of Medical Sciences Madikeri, Kodagu district Madikeri 571201 Karnataka India |
| Type of Sponsor |
Government medical college |
|
|
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 Anushka Rai |
Kodagu Institute of Medical Sciences |
Major OT
Department of Anaesthesiology
Kodagu Institute of Medical Sciences
Kodagu
Karnataka
571201
India
Kodagu
KARNATAKA |
9448770506
anushkarai44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Kodagu Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active warming |
Patients in the active warming group (Group 1) received prewarming for 20 minutes with a forced air blanket (Level 1 Snuggle Warm Blanket; Smiths Medical, Rockland, MA, USA) set at 43°C, placed over the entire body |
| Comparator Agent |
Double Blanket |
Patientsin the double blanket group ( Group 2) were covered with a double-layered blanket for 20 minutes placed over entire body |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective lower abdominal surgeries under Subarachnoid block.
2.The American Society of Anesthesiologists Physical Status (ASA-PS) Grade 1 and 2
3.Duration of surgery between 30 minutes to 90 minutes.
4.Age between 18 – 50 years
5.All Genders |
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing for the study
2.Body mass index (BMI) of more than 30 kg /m2
3.History of convulsions
4.Patient with fever
5.Pre-operative hypothermia
6.Patients having thyroid dysfunction
7.Patients having autonomic neuropathy
8.Patient who requires transfusion of blood and blood products
9.Any Known psychiatric disorders
10.Any Known musculoskeletal disorders
11.Patient on drugs (including alcohol) whose use or withdrawal can cause tremor.
12.External auditory canal pathology – stenosis, growth, ulcers, or any other pathology
13.Failed spinal anaesthesia |
|
|
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 |
To determine the effect of preoperative warming on intraoperative hypothermia.
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of preoperative warming on peri-operative shivering |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/09/2025 |
| 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="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
|
Hypothermia and shivering are common complications in patients undergoing lower abdominal surgery under spinal anesthesia. Redistribution of body heat after neuraxial blockade is the primary cause. Preoperative warming may help prevent these complications by increasing peripheral tissue temperature and reducing the core-to-peripheral gradient.
This prospective randomized clinical study will include 100 ASA 1 to 2 patients aged 18 to 50 years scheduled for elective lower abdominal surgery under subarachnoid block at a tertiary care teaching hospital.
Patients will be randomly divided into 2 groups
Group 1 Active warming Pre-warming with a forced air blanket at 43 degrees Celsius for 20 minutes Group 2 Control Covered with a double-layered blanket for 20 minutes
Core body temperature will be measured with a tympanic thermometer, and shivering will be assessed using the Crossley and Mahajan scale. Rescue medications IV Tramadol 0.5 mg per kg Ondansetron 0.15 mg per kg will be administered if required.
Primary outcome Incidence of Intraoperative hypothermia Secondary outcome Incidence and severity of perioperative shivering
The study aims to evaluate whether preoperative warming is effective in maintaining normothermia and reducing shivering during lower abdominal surgeries under spinal anaesthesia. |