| CTRI Number |
CTRI/2025/02/081077 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
THE STUDY TO KNOW THE HYPOTHERMIA AND CAUSES OF HYPOTHERMIA IN PATIENTS UNDERGOING LAPAROSCOPIC ABDOMINAL SURGERY. |
|
Scientific Title of Study
|
TO STUDY THE INCIDENCE OF HYPOTHERMIA AND FACTORS INFLUENCING HYPOTHERMIA IN PATIENTS UNDERGOING LAPAROSCOPIC ABDOMINAL SURGERY- A PROSPECTIVE OBSERVATIONAL STUDY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragati Nandedkar |
| Designation |
Junior Resident |
| Affiliation |
Lokmanya Tilak Municipal Medical Collage ,Sion |
| Address |
Department of Anesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.
MAHARASHTRA India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8308691562 |
| Fax |
|
| Email |
pragati19nandedkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepti Kotwani |
| Designation |
Associate Professor (Addl) |
| Affiliation |
Lokmanya Tilak Municipal Medical Collage ,Sion |
| Address |
Department of Anesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.
MAHARASHTRA India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870135926 |
| Fax |
|
| Email |
drdeeptikotwani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepti Kotwani |
| Designation |
Associate Professor (Addl) |
| Affiliation |
Lokmanya Tilak Municipal Medical Collage ,Sion |
| Address |
Department of Anesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.
MAHARASHTRA India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870135926 |
| Fax |
|
| Email |
drdeeptikotwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal medical college and hospital sion mumbai INDIA PIN 400022 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Pragati Nandedkar |
Lokmanya Tilak Municipal Medical College, Sion, |
Department of Anesthesiology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.
MAHARASHTRA India
Mumbai
MAHARASHTRA |
8308691562
pragati19nandedkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND LTMGH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 yrs.
Baseline body temp between 36.5-37.5 c
ASA grade 1/2/3
Surgery duration 1-4 hrs
Patient undergoing elective laparoscopic surgery |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate
Patient having any nasal pathology
Surgery duration less than 1 hr and more than 4 hrs
Basal body temperature less than 36.5 and more than 37.5 C
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Hypothermia during laparoscopic surgery
2)Shivering |
1)before induction
2) after induction every 15 min till the end of
surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify factors affecting hypothermia in laparoscopic surgery. |
1)before induction
2) after induction every 15 min till surgery going on |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
25/02/2025 |
| 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 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
|
currently majority of research of hypothermia is concentrated within the domain of open surgery in contrast there is a studies analysing the incidence and the factors influencing intra op hypothermia during laparoscopic abdominal surgery. |