| CTRI Number |
CTRI/2024/11/077289 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Difference in the effects of sevoflurane and propofol on kidney functions in patients undergoing spine surgery |
|
Scientific Title of Study
|
Comparison of effect of propofol versus sevoflurane on renal function in patients undergoing spine surgery |
| 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 Roshni Raman |
| Designation |
Post Graduate |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Department of anaesthesiology Sri ramachandra institute of higher education and research Porur,Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9003672588 |
| Fax |
|
| Email |
roshniraman97@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Vakamudi |
| Designation |
Professor M.D Anesthesiology |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Department of anaesthesiology Sri ramachandra institute of higher education and research Porur,Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
vakamudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Vakamudi |
| Designation |
Professor M.D Anesthesiology |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Department of anaesthesiology Sri ramachandra institute of higher education and research Porur,Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840022626 |
| Fax |
|
| Email |
vakamudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra institute of higher education and research Porur Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Dr Roshni Raman |
| Address |
Departement of Anaethesiology, Critical care and Pain medicine Sri ramachandra institute of higher education and research Porur Chennai- 600116 |
| Type of Sponsor |
Other [Self Financing ] |
|
|
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 Roshni |
Sri Ramachandra Institute of higher education and research |
Department of anesthesia operating rooms divisions room number A6
Chennai
TAMIL NADU |
9003672588
roshniraman97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee, Sri ramachandra insitute of higher education and research porur |
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 |
Maintenance of anaesthesia by - Sevoflurane Inhalational anaesthesia. |
General anaesthesia will be induced with Inj.propofol 2mg/kg, Inj.Fenatnyl 2mcg/kg and Inj.rocuronium 0.6mg/kg and depth of anaesthesia will be maintained with Sevoflurane anaesthesia by maintaining 0.8-1.2 Minimum alveolar concentration with a fresh gas flow of 0.8-1 liter. Propofol will not be used for post induction. Urine output will be measured for 24 hours. Serum electrolyte and serum creatinine samples and Urine samples will be taken for kidney injury molecule. The time taken for this sample measurements are Post induction and 2 hours postoperative and 24 hours post anesthesia. |
| Comparator Agent |
Maintenance of anaesthesia by - Target controlled infusion of Propofol. |
General anaethesia will be induced with Inj.propofol 2mg/kg Inj.Fentanyl and Inj.rocuronium 0.6mg/kg and depth of anaesthesia will be maintained with target controlled infusion of propofol were the plasma concentration target is set between 3-6mcg. No sevoflurane will be used for maintenance post induction.
Urine output will be measured for 24 hours. Serum electrolyte and serum creatinine samples and Urine samples will be taken for kidney injury molecule. The time taken for this sample measurements are Post induction and 2 hours postoperative and 24 hours post anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Elective spine surgery |
|
| ExclusionCriteria |
| Details |
Allergic to Propofol and Sevoflurane
Insulin treated Diabetes mellitus
BMI more than 37/kg/meter square
Kidney disease according to KDIGO criteria
NYHA class 3 and 4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urine output |
30 minutes into anesthesia
0-2 hours in the post operative period
24 hours after anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Kidney injury molecule
Serum creatinine
Creatinine clearence
Serum electrolytes |
Preoperative
30 minutes into anesthesia
0-2 hours in the post operative period
24 hours post operative |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Acute kidney injury affects 6-8% of patients undergoing surgery and is associated with increased mortality and increased risk of chronic kidney disease, Alongside indirect measurements of glomerular filtration rate and decreased urine output are the main diagnostic criteria for acute kidney injury. Intraoperative oliguria is a risk factor for subsequent acute kidney injury. This study is aimed to compare propofol vs sevoflurane anesthesia on renal excretory function, urinary markers for kidney injury before anesthesia induction, during anesthesia before surgery commences and in the post operative period. |