| CTRI Number |
CTRI/2025/11/097500 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of remifentanil-based total intravenous anaesthesia and balanced anaesthesia in preventing emergence agitation in patients undergoing nasal surgeries |
|
Scientific Title of Study
|
A comparative study To evaluate the effect of remifentanil based TIVA versus balanced anaesthesia on emergence agitation in patients undergoing nasal 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 |
Soundarya D U |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical College. |
| Address |
Department of Anaesthesiology MS Ramaiah Medical College
MSRIT Post Bangalore.
Bangalore KARNATAKA 560054 India |
| Phone |
9980372959 |
| Fax |
|
| Email |
diamondmedi99@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Archana S |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College. |
| Address |
Department of Anaesthesiology MS Ramaiah Medical College
MSRIT Post Bangalore.
Bangalore KARNATAKA 560054 India |
| Phone |
9845121444 |
| Fax |
|
| Email |
archvinddoc@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Archana S |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College. |
| Address |
Department of Anaesthesiology MS Ramaiah Medical College
MSRIT Post Bangalore.
Bangalore KARNATAKA 560054 India |
| Phone |
9845121444 |
| Fax |
|
| Email |
archvinddoc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College Bangalore MSRIT Post New BEL Road Bangalore 560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical College |
| Address |
New BEL Road MSRIT Post Bangalore 560054 |
| 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 |
| Soundarya D U |
MS Ramaiah Medical College Hospital. |
Department of Anaesthesiology Second Floor MS Ramaiah Medical College Hospital New BEL Road MSRIT Post Bangalore. Bangalore KARNATAKA |
9980372959
diamondmedi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J324||Chronic pansinusitis, (2) ICD-10 Condition: J330||Polyp of nasal cavity, (3) ICD-10 Condition: J342||Deviated nasal septum, (4) ICD-10 Condition: J343||Hypertrophy of nasal turbinates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Remifentanil based balanced anaesthesia |
Remifentanil infusion will be started at 0.5mcg/kg/min during induction with Inj. Propofol 2mg/kg over 10 seconds and isoflurane 1 vol% will be started and continued throughout the surgery. Remifentanil will be titrated between 0.3-0.5mcg/kg/min to maintain patient’s blood pressure between 20% of patient’s preoperative measurement. Remifentanil based balanced anaesthesia will start at induction of anesthesia and it is continued till the end of surgery. |
| Intervention |
Remifentanil based TIVA |
Remifentanil infusion will be started at 0.5mcg/kg/min during induction with TCI device using Schneider model with Inj. Propofol 1% and continued throughout the surgery. Remifentanil will be titrated between 0.3-0.5mcg/kg/min to maintain patient’s blood pressure between 20% of patient’s preoperative measurement.Remifentanil based TIVA will start at induction of anaesthesia and it is continued till the end of surgery . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient Aged 18-65 years.
2. Patients scheduled for elective nasal surgeries requiring GA.
3. ASA physical status 1 - 3. |
|
| ExclusionCriteria |
| Details |
1. Patients with known allergies to remifentanil or propofol.
2. History of severe cardiovascular, hepatic, or renal diseases.
3. History of substance abuse, including alcohol,or narcotics.
4. Pregnancy or breastfeeding.
5. Patients with a history of significant psychiatric conditions including severe agitation, anxiety disorders or any other conditions leading to increased risk of agitation.
6. Emergency surgery cases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of emergence agitation in remifentanil based TIVA group and Balanced Anaesthesia group based on RASS score. |
Emergence agitation will be measured 2 minutes after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recovery time T0-T1. |
Time from discontinuation of all anaesthetic agents to time taken by patient to open eyes to verbal commands. |
| Time to extubation T1-T2. |
Time from patient able to open eyes to verbal commands to extubation. |
| Post-operative pain using NRS. |
Immediately after arrival to post anaesthesia care unit ,30 min after arrival,60min after arrival . |
| Post-operative complications like post-operative nausea & vomiting, disorientation & shivering. |
Immediately after arrival to post anaesthesia care unit,30 min after arrival,60min after arrival. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
25/11/2025 |
| 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="2" 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
|
Emergence agitation is an acute, self-limited and non-fluctuating state of psychomotor excitement. This hyperactive state is confined to the emergence period after general anaesthesia Although the incidence rate of EA in adults range from 0.25% to 21.3% and time of onset typically lasts for about 15 min serious consequences can occur if patients with EA are not treated promptly. Emergence agitation can lead to serious consequences such as self-extubation, removal of catheters, haemorrhage, and even severe injuries from falling out of the bed. Furthermore, it may increase the demand on human resources and cause medical staff injuries . While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Various drugs and techniques have been proven effective in reducing the incidence of emergence agitation. Despite decades of research, studies on the occurrence rate, risk factors and prevention of emergence agitation in adult patients are still ongoing. In particular, opinions differ on the different effects of inhalation and intravenous anaesthesia. In prospective study of 1359 adult patients multivariate analysis showed that the method of anaesthesia did not affect occurrence of emergence agitation . Another prospective observational study of about 2000 adults reported that the use of volatile anaesthetic agents was associated with a higher occurrence rate of emergence agitation . Therefore the current study is designed to compare two standard techniques of anaesthesia that is remifentanil based TIVA versus balanced anaesthesia on emergence agitation. |