| CTRI Number |
CTRI/2024/07/070755 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe the effectiveness of prewarming on periopeartive hypothermia in patients receiving combined epidural and general anaesthesia in open abdominal surgeries |
|
Scientific Title of Study
|
Effectiveness of prewarming technique before combined epidural and general anaesthesia on perioperative hypothermia for open abdominal surgeries 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 |
Aniketh Kumar Shetty |
| Designation |
Student |
| Affiliation |
Kasturba medical college and hospital, MCHP, MAHE, Manipal |
| Address |
Manipal college of health professions, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8861573667 |
| Fax |
|
| Email |
anikethshetty19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savan Kumar Nagesh |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba medical college and hospital, MAHE, Manipal |
| Address |
Kasturba medical college and hospital, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105308865 |
| Fax |
|
| Email |
savankum@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aniketh Kumar Shetty |
| Designation |
Student |
| Affiliation |
Manipal college of health professions, MAHE, Manipal |
| Address |
Anaesthesia and Operation Theatre Technology, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8861573667 |
| Fax |
|
| Email |
anikethshetty19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital MAHE Tiger circle road Manipal Udupi Karnataka India 576104 |
|
|
Primary Sponsor
|
| Name |
Aniketh Kumar Shetty |
| Address |
Anaesthesia and Operation Theatre Technology MCHP MAHE Manipal Udupi Karnataka India 576104 |
| 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 Savan Kumar Nagesh |
Kasturba medical college and hospital Manipal |
KMC Manipal Department of Anaesthesiology Operation theatre
Udupi
KARNATAKA |
8105308865
savankum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing open abdominal surgeries
Patients with ASA grading I,II or III |
|
| ExclusionCriteria |
| Details |
Patient refuses epidural analgesia
Any emergency procedure with no prewarming time |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Variation in core body temperature from the baseline to the post operative period |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of participants experiencing shivering in PACU |
8 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/07/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
There have been studies showing effective period of prewarming before the procedure which prevents the onset of hypothermia by the end of the surgical procedure. There has been lack pf studies focusing on prewarming in open abdominal surgery under combined epidural and general anaesthesia. |