| CTRI Number |
CTRI/2024/10/075652 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficay of preconditioninh with nasal clamping and mouth breathing training in reducing emergence delirium in post endoscopic sinus surgery |
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Scientific Title of Study
|
Effect of nasal clamping and mouth breathing training in reducing emergence delirium post endoscopic sinus surgery - randomised controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sargam Gupta |
| Designation |
Post graduate |
| Affiliation |
Bangalore Medical College and Research Institute Bangalore |
| Address |
Department of Anesthesiology Bangalore Medical College and Research Institute KR Road, Fort Bangalore Karnataka
Bangalore Medical College and Research Institute, Bengaluru Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9902026948 |
| Fax |
|
| Email |
sargamgupta3108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi DSouza |
| Designation |
Assistant professor |
| Affiliation |
Bangalore Medical College and Research Institute Bangalore |
| Address |
Department of Anesthesiology Bangalore Medical College and Research Institute KR Road Fort Bangalore
Bangalore Medical College and Research Institute KR Road Fort Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9901755424 |
| Fax |
|
| Email |
rashmi.dsz10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi DSouza |
| Designation |
Assistant professor |
| Affiliation |
Bangalore Medical College and Research Institute Bangalore |
| Address |
Department of Anesthesiology Bangalore Medical College and Research Institute KR Road Fort Bangalore
Bangalore Medical College and Research Institute KR Road Fort Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9901755424 |
| Fax |
|
| Email |
rashmi.dsz10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Bangalore Medical College and Research Institute KR Road Fort Bangalore 560002 |
| 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 Rashmi DSouza |
Bangalore Medical College and Research Institute, Bengaluru |
Department of Anesthesiology Bangalore Medical College and Research Institute KR Road Fort Bangalore
Bangalore
KARNATAKA |
9901755424
rashmi.dsz10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Medical College and Research Institute Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General anaesthesia for endoscopic sinus surgery |
Patients undergoing endoscopic sinus surgery under general anaesthesia without Preconditioning with nasal clamping and mouth breathing training |
| Intervention |
Nasal clamping and mouth breathing training pre operatively |
Pre conditioning with Nasal clamping and mouth breathing training for 30 minutes one day prior to the surgery and on the day of the surgery before general anesthesia in Functional endoscopic sinus surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written informed consent belonging to American Society of Anaesthesiologist I and II undergoing endoscopic sinus surgery, septoplasty and turbinoplasty requiring post surgery nasal packing.
|
|
| ExclusionCriteria |
| Details |
Patients not willing to give informed consent
Patients with known allergy to any study drug |
|
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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 assess emergence delirium post nasal surgery |
To assess emergence delirium with RAS at 1min 5min 10 min 15 min 20 min 25 min 30 min 1hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess opiod requirements over 24 hrs post surgery |
To assess NRS and rescue analgesia at immediately,30 min 1hr 2 hr 8hrs 12 hrs 24 hrs |
| To assess haemodynamic parameters heart rate mean arterial pressure post operatively |
To assess haemodynamic parameters heart rate mean arterial pressure immediately 30 min 1hr 2 hr 8hrs 12 hrs 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
29/10/2024 |
| 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="0"
Months="4"
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 delirium is a short term state of dissociation of consciousness during the recovery from general anaesthesia along with motor agitation,incoherence ,inconsolability and unresponsiveness.(1-3) It is the most common neuropsychiatric complications after surgery . Emergence delirium is self-limiting but sometimes the agitated behaviour may result in post anaesthesia care unit accidents.(4) Emergence delirium may be associated with increased risks of long term adverse outcomes like cognitive dysfunction and negative behaviour that cause lower quality of life, readmission to hospitals ,and even deaths.(5,6) Emergence delirium may arise by an imbalance between the patient’s arousal state and the recovery of consciousness. Interventional strategies like medical interventions - Gabapentin, Dexmeditomidine , Melatonin and Remelteon and non pharmacological interventions such as time and place orientation are employed to reduce the incidence of emergence delirium.(7,8) During the emergence from anaesthesia, obstruction by nasal packing cause breathing difficulties and a feeling of suffocation due to forceful mouth breathing which increases the risk of emergence delirium. Risk factors for emergence delirium are age,smoking , pre-operative anxiety, types of operation, postoperative pain,etc .(9,10) The study aims at evaluating the efficacy of preoperative patient training and training with nasal clamping and mouth breathing training on prevention of emergence delirium and to identify associated risk factors for emergence delirium.
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