| CTRI Number |
CTRI/2025/09/094112 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How listening music can affect the amount of sedation drug needed during spinal anaesthesia |
|
Scientific Title of Study
|
Comparative evaluation of the effect of binaural beats and classical music on midazolam requirement for Bispectral index(BIS) guided sedation during spinal anaesthesia:A 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 Zainual Abideen |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no. 415,Third Floor BL Taneja Block,Department of Anesthesiology,Maulana Azad Medical College,New Delhi
Central
DELHI
110002
India |
| Phone |
9354561423 |
| Fax |
|
| Email |
zabideen38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Gupta |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no. 415,Third Floor BL Taneja Block,Department of Anesthesiology,Maulana Azad Medical College,New Delhi
Central
DELHI
110002
India |
| Phone |
9868092739 |
| Fax |
|
| Email |
lalit.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalit Gupta |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no. 415,Third Floor BL Taneja Block,Department of Anesthesiology,Maulana Azad Medical College,New Delhi
Central
DELHI
110002
India |
| Phone |
9868092739 |
| Fax |
|
| Email |
lalit.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College And Associated Lok Nayak Hospital,New Delhi- 110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital, JLN 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 |
| Dr Zainual Abideen |
Lok Nayak Hospital |
Department of Anesthesiology,BL Taneja block,Maulana Azad Medical College,Lok Nayak Hospital,JLN marg,New Delhi 110002 Central Delhi
Central
DELHI |
09354561423
zabideen38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Intervention |
Binaural Beats Music |
A noise cancelling headphones will be given to the patient Binaural Beats will be played to aid in midazolam sedation during spinal anesthesia |
| Intervention |
Classical Neelambari Music |
A noise cancelling headphones Will be given to the patient Classical Neelambari Music will be played to aid in midazolam sedation during Spinal Anaesthesia |
| Comparator Agent |
Control |
No intervention will be applied to the patient and solely based on midazolam level of sedation will be assessed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American society of anesthesiologist Grade I and II |
|
| ExclusionCriteria |
| Details |
Pregnant patients
Bleeding or coagulation abnormality
Local skin infection at the site of spinal block
History of OSA
Inability to understand the procedure
Hearing impairment
BMI more than equal to 35 kg per metre square
Surgery in prone position
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The total dose of intravenous midazolam required to maintain sedation at BIS 70-80 |
BIS at baseline
Midazolam first dose at baseline
Midazolam subsequent doses,if required, after every five minutes.
time to start midazolam infusion
at the end of 2 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time from start of sedation to achieve BIS less than 80.
Time for BIS to return above 90 after discontinuation of midazolam.
Patient satisfaction score at the time of shifting from Post Anaesthesia Care Unit |
Every 10 minutes
At the end of surgery
Before shifting to PACU |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
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)
|
01/10/2025 |
| 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="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
|
We are comparing the effect of Binaural beats and Classical Neelambari Music in midazolam dose requirement for BIS guided sedation under Spinal Anesthesia In Lok Nayak Hospital Delhi. Atotal of 123 patients with 41 in each group will be enrolled for this study. Patients will be explained about the study and written informed consent will be signed.We will be using the standard Spinal Anesthesia for induction of the patients following which either of the two intervention will be applied along with 0.02mg/kg midazolam will be administered.BIS guided sedation will be assessed every 5 minutes to note the total dose of midazolam required and time to reach a BIS value 70-80. Patient satisfaction will be assessed before shifting out from PACU. |