| CTRI Number |
CTRI/2025/12/099777 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of anaesthetic drug use in surgical patients receiving sevoflurane alone or sevoflurane with dexmedetomidine during general anaesthesia. |
|
Scientific Title of Study
|
Comparison of consumption of sevoflurane versus sevoflurane with dexmedetomidine using bispectral index and end tidal anaesthetic gas concentration in surgical patients under general anaeasthesia - a randomised controlled trial. |
| 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 Taanya Mahesh |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences & Research Centre |
| Address |
15, Hesarghatta Road, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9535748189 |
| Fax |
|
| Email |
drtaanyamahesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreyavathi R |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Sapthagiri Institute of Medical Sciences & Research Centre |
| Address |
15, Hesarghatta Road, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9880588325 |
| Fax |
|
| Email |
shreyamurthy8993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Taanya Mahesh |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences & Research Centre |
| Address |
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
9535748189 |
| Fax |
|
| Email |
drtaanyamahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of Medical Sciences and Research Centre, 15, Hesarghatta Road, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090, India |
|
|
Primary Sponsor
|
| Name |
apthagiri Institute of Medical Sciences and Research Centre |
| Address |
15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 |
| 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 Taanya Mahesh |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesiology
Bangalore
KARNATAKA |
09535748189
drtaanyamahesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
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 |
Dexmedetomidine |
Dexmedetomidine is an alpha agonist having sedative, anxiolytic, hypnotic, analgesic, and sympatholytic properties. |
| Intervention |
One group will be given dexmedetomidine to determine if the drug reduces the consumption of sevoflurane. |
Dexmedetomidine will be given in a dose of one microgram per kg over ten minutes, fifteen minutes before induction. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists Grade 1 and 2. Surgery under general anaesthesia. Body mass index (BMI) lesser than 30 kg per square metre. Patient willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
Patients allergic to study drug. Alcohol abusers, history of psychiatric illness. Altered mentation, epilepsy. On beta blockers, sedative or stimulant drugs. With uncontrolled hypertension and diabetes mellitus. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the consumption of sevoflurane in comparison with sevoflurane and dexmedetomidine using Bispectral index and End tidal anaesthetic gas concentration. |
after intubation, every five minutes for half an hour, every fifteen minutes till extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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 - NO
|
|
Brief Summary
|
This randomized controlled study compares the amount of sevoflurane used during general anaesthesia when given alone versus when combined with a single pre-induction dose of dexmedetomidine. Sixty adult surgical patients (ASA I–II) will be monitored using Bispectral Index (BIS) and End-Tidal Anaesthetic Gas concentration (ETAG) to maintain a uniform depth of anaesthesia. The study will measure total sevoflurane consumption, along with heart rate and blood pressure trends. The aim is to determine whether dexmedetomidine reduces sevoflurane requirement and provides better haemodynamic stability during surgery. |