| 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
|
|
|
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
|
|
|
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. |