| CTRI Number |
CTRI/2025/01/079287 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Monitoring of core body temperature in adults undergoing general anaesthesia |
|
Scientific Title of Study
|
Effect of intraoperative core temperature on recovery from general anaesthesia in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali T M Ollapally |
| Designation |
Associate professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Dept of anaesthesiology 2nd floor
st johns medical college hospital
Bangalore
KARNATAKA
560034
India |
| Phone |
9886474530 |
| Fax |
|
| Email |
dr.anjaliollapally@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali T M Ollapally |
| Designation |
Associate professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Dept of anaesthesiology 2nd floor
st johns medical college hospital
Bangalore
KARNATAKA
560034
India |
| Phone |
9886474530 |
| Fax |
|
| Email |
dr.anjaliollapally@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali T M Ollapally |
| Designation |
Associate professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Dept of anaesthesiology 2nd floor
st johns medical college hospital
Bangalore
KARNATAKA
560034
India |
| Phone |
9886474530 |
| Fax |
|
| Email |
dr.anjaliollapally@gmail.com |
|
|
Source of Monetary or Material Support
|
| St johns medical college hospital sarjapur road, bangalore, 560034 |
|
|
Primary Sponsor
|
| Name |
Dr Anjali T M Ollapally |
| Address |
st johns medical college hospital |
| Type of Sponsor |
Other [self] |
|
|
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 Anjali T M Ollapally |
St Johns medical college hospital |
2nd and 3rd floor OT complex, Dept of anaesthesiology
Bangalore
KARNATAKA |
9886474530
dr.anjaliollapally@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns medical college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy volunteers |
| Patients |
(1) ICD-10 Condition: R190||Intra-abdominal and pelvic swelling, mass and lump, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults between 18 to 65 years
2 Posted for a surgery with a duration of 3 to 6 hours
3 American Society of Anaesthesiologists Physical Status I and II
4 Willing to consent
|
|
| ExclusionCriteria |
| Details |
• Patients who are ASA PS III and IV posted for any surgery
• Patients who will be electively ventilated postoperatively
• Patients who are on Anti-epileptics, anti-psychotics etc, that affect anaesthetic drug metabolism
• Patients who are undergoing Functional Endoscopic Sinus Surgery any other nasal surgery
• Patients who have structural abnormalities of the nose or nasopharynx
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate intraoperative and immediate postoperative core body temperature with time taken to recover from general anaesthesia. |
At completion of surgery. Only 1 time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the difference in the intraoperative and immediate postoperative core body temperature between sexes, and to evaluate if these relate to recovery from general anaesthesia. |
every 20 minutes intraoperatively |
|
|
Target Sample Size
|
Total Sample Size="317"
Sample Size from India="317"
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)
|
03/02/2025 |
| 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="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
|
Inadvertent intraoperative
hypothermia (IPH), defined as a core body temperature <36℃, increases the
risk of morbid cardiac events in the perioperative period (1),
increases surgical blood loss due to coagulopathy (2), alters anaesthetic drug kinetics which
may lead to a delayed recovery (3), and results in excessive shivering in the post anaesthesia care unit. Shivering
increases oxygen consumption and metabolic demand, in addition to being a cause
of discomfort and distress to the patient (3)(4,5) This study aims to document the incidence of IPH in an
Indian tertiary hospital setting, and to evaluate the relation between intra-
and post-operative core body temperature on recovery from anaesthesia. With
this knowledge, we can institute appropriate preventive measures to aid a
faster and smoother recovery from anaesthesia.
|