| CTRI Number |
CTRI/2024/01/061914 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare the peri-Operative blood glucose levels in spinal versus general anaesthesia in non diabetic patients undergoing surgeries |
|
Scientific Title of Study
|
Comparative study of peri-operative blood glucose levels in spinal anaesthesia versus general anaesthesia in non-diabetics undergoing elective surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IECKMCMLR-03/2023/90 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Neelambara |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department Of Anaesthesiology,
Kasturba Medical College Mangalore
575003
Dakshina Kannada
Karnataka
Kasturba Medical College Mangalore
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9844367520 |
| Fax |
|
| Email |
neelambara31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Y V |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College Mangalore
575003
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9845085108 |
| Fax |
|
| Email |
suresh.yv@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Y V |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College Mangalore
575003
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9845085108 |
| Fax |
|
| Email |
suresh.yv@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education Manipal, Dakshin Kannada Karnataka576104 |
|
Primary Sponsor
Modification(s)
|
| Name |
Dr Neelambara |
| Address |
Department of Anaesthesiology Kasturba Medical College Light
House Hill Road Mangalore 575001 |
| 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 Neelambara |
Kasturba Medical College, Mangalore |
Department of Anaesthesiology
Kasturba Medical College, Mangalore
575003
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA |
9844367520
neelambara31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Kasturba Medical College Mangalore |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in between 20-50 years of age of both genders
2. Patients falling under ASA I and II
3. Patients undergoing elective surgery |
|
| ExclusionCriteria |
| Details |
1. Not willing to participate
2.known case of diabetes mellitus I and II
3. Anticipated duration of procedure more than 2 hours
4.ASA -III and above
5. Emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perioperative blood glucose changes during surgery |
2.5 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic variables |
2.5 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
31/01/2024 |
| 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="1"
Months="3"
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
|
To study peri-operative blood glucose level changes in patients who are undergoing surgeries using spinal anaesthesia versus general anaesthesia in non diabetics undergoing elective surgery and also study the changes in haemodynamic parameters like pulse, blood pressure, mean arterial pressure, saturation and compare them in the two groups. |