| CTRI Number |
CTRI/2025/03/083071 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of anesthesia with anaesthetic gas sevoflurane versus isoflurane on blood sugar levels in brain cancer surgeries |
|
Scientific Title of Study
|
Comparison of the effect of anesthesia with sevoflurane versus isoflurane on blood glucose trends in intracranial mass excision 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 Nitu Yadav |
| Designation |
Assistant Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Room no 10
2nd floor
Department of anaesthesia, new ot complex
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
918708642484 |
| Fax |
|
| Email |
ynitu29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitu Yadav |
| Designation |
Assistant Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Room no 10
2nd floor
Department of anaesthesia, new ot complex
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
918708642484 |
| Fax |
|
| Email |
ynitu29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitu Yadav |
| Designation |
Assistant Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Room no 10
2nd floor
Department of anaesthesia, new ot complex
PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
918708642484 |
| Fax |
|
| Email |
ynitu29@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor
New operation theatre complex Department of anaesthesia
PGIMS ROHTAK, haryana India
postal code- 124001 |
|
|
Primary Sponsor
|
| Name |
PGIMS Rohtak |
| Address |
2nd floor
New operation theatre complex Department of anaesthesia
PGIMS ROHTAK, haryana India
postal code- 124001 |
| Type of Sponsor |
Government 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 Nitu yadav |
PGIMS Rohtak |
Room no 10, 2nd floor
New operation theatre complex Department of anaesthesia
Rohtak
HARYANA |
8708642484
ynitu29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Commitee, PGIMS Rohtak |
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 |
Isoflurane |
Isoflurane will be used as maintainence agent through inhalational route during general anaesthesia in a concentration so as to achieve minimal alveolar concentration of 0.9- 1 in patients undergoing intracranial mass excision surgeries from induction till end of surgery and the hourly change in blood sugar levels during per operative period will be compared with sevoflurane group |
| Comparator Agent |
Sevoflurane |
Sevoflurane will be used as maintainence agent through inhalational route during general anaesthesia in a concentration so as to achieve minimal alveolar concentration of 0.9- 1 in patients undergoing intracranial mass excision surgeries from induction till end of surgery and the hourly change in blood sugar levels during per operative period will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of any sex, non diabetic, ASA status I & II and posted for intracranial mass excision surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
The patients who are diabetic, have disorders of glucose metabolism, are pregnant and lactating , have renal, cardiovascular, pulmonary or hepatic disease, are chronic alcoholic, are taking insulin, oral hypoglycemic agents, antipsychotic drugs and beta adrenergic blocking drugs or are not willing to give consent |
|
|
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 |
| To note the baseline blood glucose level (before induction) and then the hourly change in intraoperative glucose levels with the use of sevoflurane or isoflurane as a maintenance inhalational agent. |
Before induction and every hour after induction till completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note the baseline heart rate, saturation and mean arterial blood pressure and intraoperatively every 2 hour after induction. |
Before induction and every two hour after induction till completion of surgery |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - data will be available on website where article will be published
- For how long will this data be available start date provided 01-01-2026 and end date provided 17-02-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study is a prospective double blind randomized
clinical trial. Aim of the study is to compare the c in non diabetic patients
undergoing intracranial mass excision surgery. The objective of the study is to
see the change in hourly blood sugar level trends from baseline, with the intraoperative
use of inhalational agents; sevoflurane and isoflurane for maintainence.This study is a prospective double blind randomized
clinical trial. Aim of the study is to compare the c in non diabetic patients
undergoing intracranial mass excision surgery. The objective of the study is to
see the change in hourly blood sugar level trends from baseline, with the intraoperative
use of inhalational agents; sevoflurane and isoflurane for maintainence. |