| CTRI Number |
CTRI/2024/02/063047 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation between perfusion index and intraoperative core body temperature fall. |
|
Scientific Title of Study
|
A study on association between peri operative perfusion index and core body temperature fall after induction of general anaesthesia in laparoscopic gastrointestinal 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 Leo Varghese |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology, Amala Institute of medical sciences, Thrissur, Kerala
Thrissur
KERALA
680555
India |
| Phone |
07012272869 |
| Fax |
|
| Email |
leosonjoy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satheedevi P |
| Designation |
Head of department |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, AMALA INSTITUTE OF MEDICAL SCIENCES, AMALA NAGAR, THRISSUR
Thrissur
KERALA
680555
India |
| Phone |
07012272869 |
| Fax |
|
| Email |
drsathee171@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leo Varghese |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, AMALA INSTITUTE OF MEDICAL SCIENCES, AMALA NAGAR, THRISSUR
Thrissur
KERALA
680555
India |
| Phone |
07012272869 |
| Fax |
|
| Email |
leosonjoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute Of Medical Sciences, Thrissur, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Amala Institute Of Medical Sciences |
| Address |
Amala Institute Of Medical Sciences, Amalanagar, Thrissur, Kerala, India, 680545 |
| Type of Sponsor |
Private 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 Leo Varghese |
Amala Institute Of Medical Sciences |
1st floor, Chavara Block, Dept Of Anesthesiology, Amala Institute Of Medical Sciences, Amalanagar
Thrissur
KERALA |
07012272869
leosonjoy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amala Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Core body temperature fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA 1 or 2
2. Age between 18-60 years
3. BMI 20-25 kg/m2
4. Laproscopic gastrointestinal surgeries |
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent for procedure
2. Patients with peripheral vascular diseases
3. Patients who underwent blood transfusions during surgery
4. Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Core body temperature fall during conduct of general anesthesia. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shivering at the end of general anesthesia will be assessed at recovery room. |
1 day |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
29/02/2024 |
| 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 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
|
Induction of general anesthesia results in redistribution of heat from th ecentral to peripheral parts of the body.This can cause intraoperative hypothermia. This study has been formulated to determine if perfusion index can be used as a parameter to predict this hypothermia. |