| CTRI Number |
CTRI/2025/03/081996 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between inhalational agents isoflurane and sevoflurane on blood glucose level and surgical stress response in patients posted for elective intracranial surgeries |
|
Scientific Title of Study
|
Effect of intraoperative use of isoflurane and sevoflurane on blood glucose level in patients posted for elective intracranial surgeries: A randomized double blinded 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 |
Priyanka Routray |
| Designation |
Post graduate Resident |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of anaesthesiology
Institute of medical science and SUM Hospital
Siksha o anusandhan university
Bhubaneswar
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
08342874625 |
| Fax |
|
| Email |
priyankaug3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sumita swain |
| Designation |
associate professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of anaesthesiology
Institute of medical science and SUM Hospital
Siksha o anusandhan university
Bhubaneswar
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7978183938 |
| Fax |
|
| Email |
sumitabikash2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sumita swain |
| Designation |
associate professor |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of anaesthesiology
Institute of medical science and SUM Hospital
Siksha o anusandhan university
Bhubaneswar
Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
7978183938 |
| Fax |
|
| Email |
sumitabikash2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology, IMS and SUM hospital, Bhubaneswar 751003 |
|
|
Primary Sponsor
|
| Name |
Institute of medical sciences and SUM Hospital |
| Address |
K8 Kalinga Nagar
Bhubaneswar
Odisha |
| Type of Sponsor |
Private medical college |
|
|
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 Priyanka Routray |
Institute of medical sciences and SUM Hospital |
Department of anesthesiology
neurosurgery OT
K8 Kalinga Nagar
Bhubaneswar
Orissa 751003
Khordha
ORISSA |
08342874625
priyankaug3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IMS and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C69-C72||Malignant neoplasms of eye, brain and other parts of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
isoflurane |
The amount of inhalational agent present in the alveoli after starting the procedure is to be noted every hour for a period of four hours intraoperatively to record the depth of anaesthesia and blood glucose level |
| Comparator Agent |
sevoflurane |
The amount of inhalational agent present in the alveoli after starting the procedure is to be noted every hour for a period of four hours intraoperatively to record the depth of anaesthesia and blood glucose level |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients posted for elective intracranial surgeries |
|
| ExclusionCriteria |
| Details |
diabetic, pregnant, comorbidities, thyroid dysfunction, renal disease, glucose metabolism disorder |
|
|
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 |
| difference in hourly intraoperative blood glucose levels in patients undergoing elective intracranial surgeries while using isoflurane compared to sevoflurane |
heart rate blood pressure mean arterial pressure surgical stress response to be measured at Baseline
first hour
second hour
third hour
fourth hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| attenuation of surgical stress response as measured by Surgical plethysmography index |
1 year |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
18/03/2025 |
| 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="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
|
The study identifies the anaesthetic agent that offers better control over blood glucose levels in patients undergoing intracranial surgeries. This ultimately improves patient outcome and reduces the healthcare cost associated with [post operative complications. |