| CTRI Number |
CTRI/2024/06/068477 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| 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
|
Effect of music on anxiety of patients undergoing fibreoptic intubation and its comparison with dexmedetomidine |
|
Scientific Title of Study
|
Comparative evaluation of music therapy with dexmedetomidine on comfort level during awake fibreoptic intubation in patients with difficult airway |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deen Bandhu Choudhary |
| Designation |
PG Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 315 third floor Department of Anaesthesiology and intensive Care
BL Taneja Block
Maulana Azad Medical Colege
Central
DELHI
110094
India |
| Phone |
09818314062 |
| Fax |
|
| Email |
bandhu1996b@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia wadawan |
| Designation |
Director professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 312 third floor Department of Anaesthesiology and intensive Care
BL Taneja Block
Maulana Azad Medical Colege
Central
DELHI
110094
India |
| Phone |
09818314062 |
| Fax |
|
| Email |
soniawadhawan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deen Bandhu Choudhary |
| Designation |
PG Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 315 third floor Department of Anaesthesiology and intensive Care
BL Taneja Block
Maulana Azad Medical Colege
Central
DELHI
110094
India |
| Phone |
09818314062 |
| Fax |
|
| Email |
bandhu1996b@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college and associated Lok Nayak Hospital |
| Address |
Maulana azad medical college, Bahadur shah jafar marg, new delhi -110002 |
| 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 |
| Deen Bandhu Choudhary |
Lok Nayak Hospital |
OT block , OT 1,2,3 new operation theatre block department of anaesthesiology central delhi
Central
DELHI |
9818314062
bandhu1996b@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maulana Azad Medical College |
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 |
Dexmedetomidine infusion |
Dexmedetomidine infusion at the rate of 0.5microgram/kg/hour will be started in the preoperative period after noting baseline anxiety levels and haemodynamic parameters. Fifteen minutes after the commencement of infusion , vitals and anxiety scores will be assessed again. Thereafter the infusion of dexmedetomidine will be continued till the completion of procedure. |
| Intervention |
Music therapy
(Raga Hamsadhawni group) |
In this group, patients will be made to listen Raga Hamsadhawni at 60dB using noise cancelling headphones. Music will be started in the preoperative period after recording baseline anxiety levels and haemodynamic parameters. Fifteen minutes after beginning of music , anxiety score and vitals will be noted. Intervention will be continued till the completion of fiberoptic procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASAgrade 1,2,3 |
|
| ExclusionCriteria |
| Details |
1. Documented or diagnosed hearing impairment
2. Documented or diagnosed psychiatric or neurological illness
3. Patients with bleeding disorder.
4.Known allergies to any drug likely to be used during anaesthesia
5. Patient with nasal trauma, fracture base of skull, any history of epistaxis,nadsal poly/tumor.
6.Anticipated post op mechanical ventilation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient comfort score |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety levels |
Baseline and 15 minutes after intervention |
| Mean arterial pressure, systolic blood pressure, diastolic blood pressure and oxygen saturation |
Baseline and at every 2 minutes interval till completion of intubation |
| Total time taken for awake fiberoptic intubation |
starting from insertion of fiberoptic cable into one of the nostril till placement of endotracheal tube into the tracheal |
| Anaesthesiologists perception of difficulty in fiberoptic intubation |
after completion of fiberoptic intubation |
| serum cortisol and IL-6 levels |
baseline, after intubation and 6 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="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
|
Title of my thesis is, COMPARATIVE EVALUATION OF MUSIC THERAPY WITH DEXMEDETOMIDINE ON COMFORT LEVEL DURING AWAKE FIBREOPTIC INTUBATION IN PATIENTS WITH DIFFICULT AIRWAY. We are going to take sample size of 32 . 16 in each group, and we are going to compare patient comfort level during awake fiber optic intubation |