| CTRI Number |
CTRI/2024/05/068062 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of spinal anaesthesia and general anaesthesia on blood glucose levels in lower abdominal surgeries |
|
Scientific Title of Study
|
Prospective Non Randomized interventional study to compare the effect of spinal anaesthesia versus general anaesthesia on Blood Glucose concenteration in patients undergoing lower abdominal surgeries at SMS Medical College and Hospital,Jaipur |
| 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 Varsha Kothari |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology,Second floor,Dhanwantri Building , SMS Medical College
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828020186 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Kothari |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology,Second Floor Dhanwantri Building , SMS Medical College
RAJASTHAN
302004
India |
| Phone |
9828020186 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology ,Second Floor, Dhanwantri Building, SMS MEDICAL COLLEGE
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107191195 |
| Fax |
|
| Email |
sagardhamija.dhamija@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology ,SMS Medical college ,JLN Marg ,Jaipur , Rajasthan PIN 302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
SMS Medical College JLN marg jaipur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sagar |
SMS Medical college |
Orthopaedics Operation theatre Second Floor Dhanwantri Building
Jaipur
RAJASTHAN |
8107191195
sagardhamija.dhamija@gmail.com |
| Dr Sagar |
SMS Medical college |
Urology Operation Theatre seventh floor Superspeciality Building
Jaipur
RAJASTHAN |
8107191195
sagardhamija.dhamija@gmail.com |
| Dr Sagar |
SMS Medical college and attached hospitals |
General Surgery Operation theatre main building SMS Medical College
Jaipur
RAJASTHAN |
8107191195
sagardhamija.dhamija@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS |
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 |
Blood Glucose Concenteration |
Blood Glucose measurement at different time intervals in patients undergoing elective lower abdominal surgeries under spinal anaesthesia using 3 ml hyperbaric bupivacaine
Blood Glucose measurement till 30 minutes after completion of surgery (total duration of surgery 90 minutes average) |
| Comparator Agent |
Blood Glucose Measurement |
Blood glucose Measurement at different time intervals in patients undergoing elective lower abdominal surgeries under general anaesthesia using Propofol as induction agent
Blood Glucose measurement till 30 minutes after completion of surgery.(total duration of surgery 90 minutes average) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing scheduled elective surgeries
2.patients willing to give informed written consent 3.ASA Grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Any Cardiovascular disorder
2.Any Respiratory Disorder
3.diabetic patients
4.Hypertensive patients
5.Neurological disorders
6.Drug allergy , if any |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Blood Glucose Concenteration |
5 minutes before induction
5 minutes after induction
5 minutes before completion
30 minutes after completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Hemodynamic variables |
Baseline
15 minutes
30 minutes
45 minutes
60 minutes
90 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="0"
Months="2"
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
|
The Etiology of hyperglycemia is multifactorial , but is thought primarily to be the result of activation of the sympathoadrenal system ,with contributions from the hypothalamus and adenohypophysis. The stress response triggers an increase in levels of plasma catecholamines and glucocorticoids ,which in turn lead to hyperglycemia . cortisol also has a huge impact on the glucose metabolism in stress, because by increasing glycogenolysis and glucogenesis it can lead to hyperglycemia . the aim of the study is t determine the significance of spinal anaesthesia in supressing the metabolic , and hemodynamic response to surgical stress during and after elective abdominal urological and orthopaedics surgery compared with the technique of general anaesthesia |