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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.

 
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