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CTRI Number  CTRI/2026/03/106192 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
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   Study to See if repeated instruction on how to breathe can reduce agitation while coming out of anaesthesia in people who are having nose and sinus surgery under general anaesthesia  
Scientific Title of Study   Effects of a repeated verbal reminder of breathing pattern on emergence agitation after general anaesthesia for nose and sinus surgeries A one year 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  Rituparna Mishra 
Designation  Post Graduate Student 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Anaesthesiology,KLE Dr Prabhakar kore hospital,Nehru Nagar,Balagavi
JNMC KLE University Campus,Nehru nagar,Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  8778392303  
Fax    
Email  rituparna99mishra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kedareshvara K S 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Anaesthesia,KLEs Dr.Prabhakar Kore Hospital And Medical Research Centre
JNMC KLE University Campus,Nehru nagar,Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9886375154  
Fax    
Email  kedareshvara@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kedareshvara K S 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Anaesthesia,KLEs Dr.Prabhakar Kore Hospital And Medical Research Centre
JNMC KLE University Campus,Nehru nagar,Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  9886375154  
Fax    
Email  kedareshvara@gmail.com  
 
Source of Monetary or Material Support  
JNMC KLE University,Nehru Nagar,Belgaum,Karnataka,India,PIN 590010 
 
Primary Sponsor  
Name  Rituparna Mishra 
Address  Department of Anaesthesiology ,KLE Dr Prabhakar kore hospital,Nehru Nagar,Belagavi,Karnataka,India,Pin 590010 
Type of Sponsor  Other [Self] 
 
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 
Rituparna Mishra  Dr.Prabhakar Kore Hospital and Medical Research Centre  Department of Anaesthesiology,KLE Dr Prabhakar kore hospital,Nehru Nagar,Belagavi,India,PIN 590010
Belgaum
KARNATAKA 
8778392303

rituparna99mishra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group   No verbal reminder will be provided 
Intervention  Intervention Repeated verbal reminder of breathing pattern  Subjects will be given instruction to breathe through mouth as nose is packed during Pre anaesthesia evaluation,before induction and during extubation with headphones 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2
Age between 10 to 60 years
Elective Nose and Sinus Surgery requiring General Anaesthesia 
 
ExclusionCriteria 
Details  ASA more than equal to 3
Pre existing conditions associated with neurological deficit
Cognitive impairment or Hearing disorders
Use of Antipsychotic Medications
Patient refusal 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Effect of repeated verbal reminder of breathing pattern on incidence of emergence agitation measured using Riker Sedation Agitation scale more than equal to 5 in patients recovering from general anaesthesia after nose and sinus surgeries  During extubation at 0min  
 
Secondary Outcome  
Outcome  TimePoints 
Data on incidence of Dangerous emergence Agitation equal to 7 measured using Riker sedation agitation scale  During extubation at 0 min  
Maximal Sedation agitation scale score measured using Riker sedation agitation scale  During extubation at 0 min 
Vitals after extubation   0 minutes
5 minutes
10 minutes 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   26/03/2026 
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  

Emergence agitation is a well known early postoperative negative behavior having many complications .It occurs more frequently in nasal and sinus surgeries due to higher sense of suffocation due to nasal packing .This randomised controlled trial is designed to examine the impact of verbally reminding the patients of their breathing pattern on occurrence of emergence agitation following general anaesthesia in contrast to patients who simply heard their own names during extubation.

 Patients will be assigned into two groups .In Interventional group the subject will be given information on course of general anaesthesia and instruction regarding breathing pattern will be provided during pre anaesthesia evaluation.

Then after subject enters the operating room before the induction of anaesthesia the subject will again be reminded and instruction of breathing pattern will be provided .

After the surgery at the start of emergence procedure they will be provided with repeated reminder of breathing pattern through headphones on patient ears with message playing on loop that Breathe through your mouth as your Nostril is packed you are now recovering from general anaesthesia after surgery open your eyes We are about to take out the tube Breathe calmly

No tactile stimulation will be allowed during the emergence .The Riker sedation agitation scale SAS will be used to score

The primary outcome will be the incidence of emergence agitation  which is defined as maximal SAS score more than equal to 5 .Secondary outcome will be Data on incidence of Dangerous emergence agitation SAS equal to 7 and Maximal SAS score during emergence and Vitals at 0 min 5 min and 10 min after extubation

Whereas those in the control group will not receive any instruction of breathing pattern previously and during extubation .They will verbally hear only their own name during extubation.

 
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