| CTRI Number |
CTRI/2025/04/085115 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
My study is meant to observe the effect of sound waves applied to both ear of, specific frequency difference, that how much difference it cause in the dose of anaestic drug and depth of anaesthesia in cases of laproscopic cholecystectomy conducted under general anaesthesia. |
|
Scientific Title of Study
|
Effect of Intraoperative Binaural beat on anaesthetic drug dose and depth of anaesthesia in laproscopic cholecystectomy cases under general anaesthesia- prospective randomized control 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 sneha kumari pandey |
| Designation |
Post graduation resident |
| Affiliation |
Rajendra Institute Of medical sciences |
| Address |
Department of Anaesthesiology RIMS ranchi Jharkhand
Ranchi
JHARKHAND
834009
India |
| Phone |
8210387380 |
| Fax |
|
| Email |
snehapandey946@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shio Priye |
| Designation |
HOD Professor Department of Anaesthesiology RIMS Ranchi |
| Affiliation |
Rajendra institute of medical sciences Ranchi |
| Address |
Department of Anaesthesiology RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9986743162 |
| Fax |
|
| Email |
shiopriye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shio Priye |
| Designation |
HOD Professor Department of Anaesthesiology RIMS Ranchi |
| Affiliation |
Rajendra institute of medical sciences Ranchi |
| Address |
Department of Anaesthesiology RIMS Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9986743162 |
| Fax |
|
| Email |
shiopriye@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra institute of medical sciences Ranchi, Jharkhand, India 834009 |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Kumari Pandey |
| Address |
Department of Anaesthesiology RIMS Ranchi, Jharkhand, India, 834009 |
| 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 |
| Dr sneha Kumari Pandey |
Rajendra institute of medical sciences |
Room no. 1, Department of Anaesthesiology, Rajendra institute of medical sciences Ranchi ,Jharkhand, India 834009
Ranchi
JHARKHAND |
8210387380
snehapandey946@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RIMS Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, (2) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No sound |
No sound will be used for patients in this group and depth of anaesthesia and requirement of anaesthetic drug dose will be observed |
| Intervention |
Use of binaural beat |
Use of binaural beat in these patients to see the changes in depth of anaesthesia and dose of anaesthetic agent as binaural beat are known to have sedative effects. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists Physical status I and II
weight less than 60 killograms
Patients with informed and written consent |
|
| ExclusionCriteria |
| Details |
Patients with history of epilepsy
Patients with deafness Patients with allergy to midazolam and propofol
Patients with psychotic and cognitive disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Depth of anaesthesia achieved with or without intraoperative binaural beat
2 Requirement of propofol to achieve same depth of anaesthesia |
5 10 15 30 45 60 minutes after application of binaural beat and start of propofol infusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of vital parameters like heart rate, Non invasive blood pressure, SPO2, End tidal CO2 |
5,10,16,30,45,60 minutes till end of surgery |
|
|
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)
|
17/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The patients undergoing lap cholecystectomy will be divided into two groups, by computer generated randomization.patients will be observed under general anaesthesia with propofol infusion and binaural beat application through headphone for anaesthetic dose requirement and depth of anaesthesia. Depth will be monitored by BIS index. |