| CTRI Number |
CTRI/2026/01/100478 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of warm Intravenous Fluid for Prevention of shivering and fall internal in body temperature in orthopedic surgical patients. |
|
Scientific Title of Study
|
Use of Prewarmed Intravenous Fluid for Prevention of Perioperative Hypothermia and Shivering in patients undergoing lower limb arthroplasty 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 |
Dr Usha Devi |
| Designation |
Associate Professor |
| Affiliation |
Adesh University, Bathinda |
| Address |
Department of Anesthesiology and Intensive Care
Adesh University
Bhucho
Bathinda
Department of Anesthesiology and Intensive Care
Adesh University
Bhucho
Bathinda
Bathinda
PUNJAB
151101
India |
| Phone |
09915461044 |
| Fax |
|
| Email |
sonaattri45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Devi |
| Designation |
Associate Professor |
| Affiliation |
Adesh University, Bathinda |
| Address |
Department of Anesthesiology and Intensive Care
Adesh University
Bhucho
Bathinda
Department of Anesthesiology and Intensive Care
Adesh University
Bhucho
Bathinda
Bathinda
PUNJAB
151101
India |
| Phone |
09915461044 |
| Fax |
|
| Email |
sonaattri45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mridul Madhav Panditrao |
| Designation |
Professor and head |
| Affiliation |
Adesh University, Bathinda |
| Address |
Department of Anesthesiology and Intensive Care
Adesh University
Bhucho
Bathinda
Department of Anesthesiology and Intensive Care
Adesh University
Bhucho
Bathinda
Bathinda
PUNJAB
151101
India |
| Phone |
8699921884 |
| Fax |
|
| Email |
drmmprao1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and intensive care, Adesh University, Bathinda, Punjab India, Pin 151101 |
| Department of Anesthesia and intensive care, Adesh University, Bathinda, Punjab, India, Pin 151101 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Usha Devi |
Adesh Hospital |
Department of anesthesiology
Orthopedic operation theatre
Arthroplasty operating room No 1 and 2
Bathinda
PUNJAB |
9915461044
sonaattri45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Adesh University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M19||Other and unspecified osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous fluid at 20 Degree Celsius |
1.5 TO 2litre during the entire surgical procedure (which usually takes 2.5 to 3.5hrs) |
| Intervention |
Intravenous fluid at 40 Degree Celsius |
1.5-2litre During the entire surgical procedure (which usually takes 2.5 to 3.5hrs) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All gender consenting patients undergoing hip or knee arthroplasty surgeries |
|
| ExclusionCriteria |
| Details |
Patients who will have baseline core body temperature more than 38 or less than 36 Degree Celsius.
Patients with impacted wax, perforation of the tympanic membrane, middle/ external ear infections.
Those with urinary tract infections, diabetic autonomic neuropathy or any neurological diseases.
Patients with deranged coagulation profile.
Those with history of allergy to the local anesthetic |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of prewarmed intravenous fluid and intravenous fluid at room temperature on core body temperature(tympanic membrane temperature measured by ear thermometer) and shivering, when given to patient during the arthroplasty surgical procedure. |
Primary outcomes will be assessed at start of surgery, at everyone minute for first 5 minutes, at every 30 mins till completion of surgery(2.5-3.5 hours) in both the groups. In recovery room we will assess the outcome at 0min(when patient reach in recovery room),30min,60min 90min and 120min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effect of prewarmed intravenous fluid on patient’s hemodynamic profile, VAS Score, incidence of nausea vomiting & time to discharge the patient from recovery room.
To identify any specific untoward side effects/ complications due to infusion of prewarmed intravenous fluid. |
Secondary outcomes will be assessed at start of surgery, at everyone minute for first 5 minutes, at every 30 mins till completion of surgery(2.5-3.5 hours) in both the groups. In recovery room we will assess the outcome at 0min(when patient reach in recovery room),30min,60min 90min & 120min. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
17/01/2026 |
| 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="0"
Months="6"
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
|
A randomized parallel Armed control trail conducted on patients who will undergo Hip and knee arthroplasty. Total number of patients enrolled will be 80, patients will be divided into two groups(I and II),40 patients in each group. Group I will be given intravenous fluid at 20 Degree Celsius and II will be the intervention group, in which we will give intravenous fluid at 40 Degree Celsius. We will compare the patient’s hemodynamic, Visual analogue score, comfort, incidence of hypothermia and shivering, time to first rescue analgesic after spinal block, and time to discharge the patient from recovery room between the two groups. |