| CTRI Number |
CTRI/2024/06/069173 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare effects of sevoflurane and isoflurane on blood glucose levels in patients with diabetes undergoing surgeries |
|
Scientific Title of Study
|
Effect of sevoflurane versus isoflurane on blood glucose levels in diabetic patients undergoing elective surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC KMC MLR 01/2024/11 18/1/24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghna Sharma |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology Kasturba Medical College
Lighthouse Hill Road Mangalore Dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7042268415 |
| Fax |
|
| Email |
drmeghnasharma02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Bhat |
| Designation |
Additional Professor Kasturba Medical College Mangalore |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology Kasturba Medical College
Lighthouse Hill Road Mangalore Dakshina Kannada Karnataka
KARNATAKA
575001
India |
| Phone |
9980014995 |
| Fax |
|
| Email |
sonal.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Bhat |
| Designation |
Additional Professor Kasturba Medical College Mangalore |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology Kasturba Medical College
Lighthouse Hill Road Mangalore Dakshina Kannada Karnataka
KARNATAKA
575001
India |
| Phone |
9980014995 |
| Fax |
|
| Email |
sonal.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Mangalore Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Meghna Sharma |
| Address |
Department of Anaesthesiology
Lighthouse Hill Road
Kasturba Medical College Mangalore 575001 |
| Type of Sponsor |
Other [Dr Meghna Sharma] |
|
|
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 Meghna Sharma |
KASTURBA MEDICAL COLLEGE |
Department of Anaesthesiology Kasturba Medical College Mangalore 575001
Dakshina Kannada
KARNATAKA |
07042268415
drmeghnasharma02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sevoflurane
Isoflurane |
Inhalational Anaesthetics Used During General Anaesthesia For 3-4 Hrs During Elective Surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All Individuals Between 20-70 Years Under ASA1 And ASA2
Individuals Who Have Given Written Informed Consent
Elective Surgeries Lasting 3-4 Hrs |
|
| ExclusionCriteria |
| Details |
Patients Not Willing To Participate
Patients Having Thyroid Dysfunction Renal Or Hepatic Disease Malignant Hyperthermia Or Severe Cardiorespiratory Diseases
Patients On Steroids Beta Adrenergic Blocking Agents
Patients Having Known Allergy To Sevoflurane Or Isoflurane |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Glucose |
1 Hr Before Shifting To Operation Theatre
Intraoperatively
1 Hr Post Operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean Arterial Pressure
Heart Rate |
Intraoperatively baseline 60 Mins 120 Mins 180 Mins |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
29/06/2024 |
| 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
|
This Is An Observational Study Which Will Include 61 Patients Of Both The Genders 20-70 Years Of Age Who Will Be Checked For Blood Glucose Levels Under Sevoflurane Or Isoflurane Baseline Blood Glucose Will Be Determined With Glucometer Patients Will Be Preoxygenated With 100% Oxygen For 3 Mins Premedicated With Injection Fentanyl Induction With Propofol And Neuromuscular Blockade With Atracurium Or Vecuronium Airway Will Be Secured With Endotracheal Tube Of Appropriate Size Maintainance With Either Sevoflurane Or Isoflurane Glucose Levels Will Be Measured 1 Hr Before Shifting Patient To Operation Theatre Intraoperatively And 1 Hr After Shifting Patient Out Hemodynamic Outcomes Including Mean Arterial Blood Pressure Will Be Recorded Hourly Intraoperatively |