| CTRI Number |
CTRI/2024/10/075923 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of 3 anaesthetic drugs on blood sugars and cortisol in gastrointestinal surgery |
|
Scientific Title of Study
|
Effect of induction of general anaesthesia with etomidate, propofol and thiopentone
on serum cortisol and blood sugars in diabetic patients undergoing open gastrointestinal surgery – A randomized controlled 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 |
Dr Indira Gurajala |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082 |
| Address |
OT3
specality block
Nizams Institute Of Medical Sciences
specality block
Hyderabad
TELANGANA
500082
India |
| Phone |
7729932044 |
| Fax |
|
| Email |
indiradevraj@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Gurajala |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082 |
| Address |
OT3
specality block
Nizams Institute Of Medical Sciences
specality block
Hyderabad
TELANGANA
500082
India |
| Phone |
7729932044 |
| Fax |
|
| Email |
indiradevraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indira Gurajala |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082 |
| Address |
OT3
specality block
Nizams Institute Of Medical Sciences
specality block
Hyderabad
TELANGANA
500082
India |
| Phone |
7729932044 |
| Fax |
|
| Email |
indiradevraj@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Nizams Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Indira Gurajala |
| Address |
OT3
specality block
Nizams Institute Of Medical Sciences
Hyderabad
Telangana
India
Pincode: 500082 |
| 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 Indira Gurajala |
Nizams Institute of Medical Sciences Hyyderabad: Pincode: 500082 |
OT3
specality block
Nizams Institute Of Medical Sciences
Hyderabad
TELANGANA |
7729932044
indiradevraj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nims Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate Group (EC) |
Etomidate induction : Single IV bolus 0.3 mg/kg in non diabetic patients |
| Intervention |
Etomidate group (ED) |
IV Etomidate 0.3 mg/kg single bolus induction in diabetic patients |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Propofol Group (PD) |
Propofol Induction: IV 2 mg/kg single bolus in Diabetic patients |
| Intervention |
Thiopentone Group (TD) |
Thiopentone induction:Single IV bolus 5 mg/kg in diabetic patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diabetic patients of either gender aged 18 to 70 years undergoing elective open gastrointestinal surgery with duration 4-8 hours under combined general and epidural anaesthesia will be included as test groups (PD, TD, ED) .
2. Non-diabetic patients of either gender aged 18 to 70 years undergoing elective open gastrointestinal surgery with duration 4-8 hours under combined general and epidural anaesthesia will be included as control group (EC).
3. preoperative HbA1C of less than 8 %. |
|
| ExclusionCriteria |
| Details |
1.hepato- biliary and pancreatic surgeries
2. other concomitant endocrine disorders,
3. receiving preop/intraop steroids and beta-blockers,
4.renal or hepatic disease and
5.Pregnant or lactating women
6.intraoperative Blood loss more than 500 ml
7. surgeries more than 8 hours duration |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare S. cortisol levels at 4 hours after etomidate/thiopentone/propofol induction in diabetic patients and etomidate induction in non diabetic patients respectively |
at 4 hours after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1..to compare S. cortisol levels at 24 hours after etomidate/thiopentone/ propofol induction in diabetic patients and etomidate induction in non-diabetic patients respectively
2. ï¬ to evaluate the blood sugar levels baseline, 4 hr, 8 hr, 12 hr, 24 hr with etomidate/thiopentone/propofol induction in diabetic patients and etomidate induction in non diabetic patients respectively .
|
1S.Cortisol at 24 hours after induction
2. blood sugar levels baseline, 4 hr, 8 hr, 12 hr, 24 hr after induction |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/11/2024 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 prospective randomised study will include 40 patients posted for elective open gastrointestinal surgeries under combined general epidural anaesthesia of both gender aged 18 to 70 years with diabetes after obtaining Institute Ethics approval ,CTRI registration and paients written informed consent.Exclusion criteria will include Hepato- biliary and pancreatic surgeries , patients receiving steroids, beta blockers, renal, hepatic disease, prgnant, lactating women. Premedication will be with tablet raniditidine and alprozolam and fasted for 6 hours before surgery. Intraop ASA Monitors will be connected. Epidural catheter will be secured at T8-10 intervertebral disc space . Premedication with fentanyl followed by induction with etomidate/thiopentone/propofol as pwer randomisation (. Later oral intubation with rocuronium muscle relaxant. Arterial cannula in radial artery will be secured Intraop maintance will be air:O2 (1:1) ,atracurium, fentanyl, sevoflurane . After surgery completion, parient will be extubated and shifted to postop area. Parameters to be measured will be Serum cortisol baseline, 4 and 24 hours after induction, blood sugars at baseline, postinduction 4, 12 and 24 hours |