| CTRI Number |
CTRI/2025/11/097461 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of hemodynamic profile between intravenous anaesthesia and intravenous plus gas anesthetic agents anaesthesia in patients with ear nose throat surgeries |
|
Scientific Title of Study
|
Comparison of hemodynamic profile betweenTarget control infusion(tci)- totalintravenous anaesthesia(tiva) and balanced inhalational anaesthesia in otorhinolaryngology surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrinda Mariam Lukose |
| Designation |
Junior Resident |
| Affiliation |
Shimoga Institute Of Medical Sciences |
| Address |
Shimoga Institute Of Medical Sciences
Department of Anaesthesiology
Sagar Road
Mission Compound
Shivamogga
Karnataka
Shimoga
KARNATAKA
577201
India |
| Phone |
9744295790 |
| Fax |
|
| Email |
vrindamariamlukose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumara A B |
| Designation |
Associate Professor |
| Affiliation |
Shimoga Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology
Shimoga Institute Of Medical Sciences
Shivamogga
Shimoga
KARNATAKA
577201
India |
| Phone |
8861958933 |
| Fax |
|
| Email |
kumarab_bmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kumara A B |
| Designation |
Associate Professor |
| Affiliation |
Shimoga Institute Of Medical Sciences |
| Address |
Department Of Anaesthesiology
Shimoga Institute Of Medical Sciences
Shivamogga
Shimoga
KARNATAKA
577201
India |
| Phone |
8861958933 |
| Fax |
|
| Email |
kumarab_bmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Shimoga Institute Of Medical Sciences
Shivamogga
Karnataka |
|
|
Primary Sponsor
|
| Name |
Shimoga Institute Of Medical Science |
| Address |
Shimoga Institute Of Medical Science
Sagar Road
Mission Compound
Shivamogga
Karnataka
India
577201 |
| 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 Vrinda Mariam Lukose |
McGann District Teaching Hospital |
Department Of Anaesthesiology
Major OT Complex
Room No 334
McGann District Teaching Hospital
Shivamogga
Shimoga
KARNATAKA |
9744295790
vrindamariamlukose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) SIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARCOMED pumps |
Induction with fentanyl Propofol Vecuronium followed by maintenance with Remifentanil Propofol via ARCOMED pumps for target controlled infusion total intravenous anaesthesia |
| Comparator Agent |
Conventional balanced inhalational anaesthesia |
Induction with Fentanyl(2microgram/kg IV) Propofol(1.5 to 2mg/kg IV) Vecuronium(0.1mg/kg IV) followed by maintenance with Sevoflurane(1 to 2% for maintaining MAC 0.9) for 120 minutes |
| Comparator Agent |
Target Control Infusion Total Intravenous Anaesthesia |
Induction with Fentanyl(2microgram/kg IV) Propofol(1.5 to 2mg/kg IV) Vecuronium(0.1mg/kg IV) followed by maintenance with Remifentanil(0.05 to 0.2 microgram/kg/min) Propofol(1.5 to 2mg/kg) via Target Controlled Infusion for 120 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing otorhinolaryngology surgeries that require general anaesthesia with target control infusion total intravenous anaesthesia and balanced anaesthesia
American Society of Anesthesiologist physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with known case of hypertension renal or hepatic disease
Patients with BMI more than 35
Patients on drugs that influence intraoperative hemodynamic stress response
Patients who are allergic to any drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients heart rate,systolic blood pressure,diastolic blood pressure,mean arterial blood pressure and end tidal carbon dioxide at the time of induction,during the maintenance phase at 5,10,15,20,25,30 and 45 minutes initially followed by every 30 minutes till 2 hours.Hemodynamic variables will be recorded immediately after extubation and 5 minutes after extubation |
T(0)-at intubation
T(1) at 5 minutes
T(2)-at 10 minutes
T(3)-at 15 minutes
T(4)-at 20 minutes
T(5)-at 25 minutes
T(6) -at 30 minutes
T(7)-at 45 minutes
T(8)-at 60 minutes
T(9)-at 90 minutes
T(10)-at 120 minutes
T(E)-immediately after extubation
T(E 5)-5 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative visual analogue score at 1 and 2 hours |
T(1) -at 1 hour
T(2)-at 2 hours |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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
|
Comparison of hemodynamic parameters and perioperative outcomes between two anaesthesia techniques Remifentanil Propofol based target control infusion total intravenous anaesthesia and Fentanyl Sevoflurane balanced inhalational anaesthesia in otorhinolaryngology surgeries |