| CTRI Number |
CTRI/2024/12/077838 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of noise cancellation and propofol dose |
|
Scientific Title of Study
|
Effect of noise cancellation on the induction dose of propofol using closed-loop anaesthesia delivery system in patients presenting for non-cardiac surgeries: prospective randomized non-inferiority clinical trail. |
| 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 Karthickeyan |
| Designation |
Junior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Junior resident,
Department of Anaesthesiology and intensive care,
level 4, Nehru hospital,
PGIMER, Chandigarh 160012. Anaesthesia office,
Department of anaesthesiology and intensive care,
level 4, Nehru hospital,
PGIMER, Chandigarh 160012. Chandigarh CHANDIGARH 160012 India |
| Phone |
9600902809 |
| Fax |
|
| Email |
akarthickeyan1998@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Venkata Ganesh |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Assistant Professor,
Department of anaesthesiology and intensive care,
level 4, Nehru hospital,
PGIMER, Chandigarh 160012 Anesthesia office,
Department of anaesthesiology and intensive care,
level 4, Nehru hospital,
PGIMER, Chandigarh 160012 Chandigarh CHANDIGARH 160012 India |
| Phone |
8427561868 |
| Fax |
|
| Email |
bjfiero@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Venkata Ganesh |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Assistant Professor,
Department of anaesthesiology and intensive care,
level 4, Nehru hospital,
PGIMER, Chandigarh 160012 Anesthesia office,
Department of anaesthesiology and intensive care,
level 4, Nehru hospital,
PGIMER, Chandigarh 160012 Chandigarh CHANDIGARH 160012 India |
| Phone |
8427561868 |
| Fax |
|
| Email |
bjfiero@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research,
Sector 12, Chandigarh, India.
pin code: 160012 |
|
|
Primary Sponsor
|
| Name |
Dr Karthickeyan |
| Address |
Junior Resident,
Department of anaesthesiology and intensive care,
level 4, Nehru hospital,
PGIMER, Chandigarh 160012. |
| 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 Karthickeyan |
Nehru Hospital |
Main OT complex,
Daycare OT,
Nehru hospital extension OT complex,
Nehru hospital,
PGIMER, Chandigarh 160012 Chandigarh CHANDIGARH |
9600902809
akarthickeyan1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Commmittee (intramural) |
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 |
Noise cancelling headphones |
Closed loop anesthesia delivery system with noise cancelling headphones with active noise cancellation, removing about 20 dB of noise from the surroundings. Headphones will be applied 5 minutes before entering OT and will be removed at the end of surgery (skin closure) |
| Comparator Agent |
only closed loop anesthesia delivery system |
closed loop anestheisa delivery system with no noise cancelling headphones. Duration: from the begining of anaesthesia induction till extubation of the patient on OT table. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients who have given consent
ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients who denied consent
ASA 3, 4, 5.
Head and neck surgeries (inability to used BIS/EEG feedback)
Known hearing loss
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the propofol dose required to achieve BIS 50 in adults presenting for elective non-cardiac surgeries when active noise cancellation is provided versus when it is not as part of CLADS based induction |
at the end of induction (first instance of BIS 50) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Estimated effect site concentration of propofol at induction
|
at the end of induction (first instance oF BIS 50) |
Time to achieve BIS-50 on induction
|
time from start of induction at BIS 100 to BIS 50 |
Total intraoperative dose of propofol (mg/kg/hr)
|
propofol dose used from starting of induction to the end of surgery |
Frequency of post induction hypotension
|
till 10 minutes after induction |
Rescue dose of phenylephrine and mephentermine used
|
from induction to end of surgery |
| Percentage of time spent between BIS 40-60 |
from induction to stopping propofol |
| Recovery time |
stop of infusion to extubation |
PONV scores
|
at 30 mins,6th, 12th, 24th hour postopearatively |
| Postoperative NRS pain scores |
at 30 mins, 6th, 12th, 24th hour of postoperative period |
| Postoperative delirium |
at 30 mins, 6th, 12th, 24th hour postoperatively |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be available with the corresponding author after publication and will be shared if the request appears genuine
- For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The noise
exposure in the hospital influences
several patient outcomes and adverse outcome includes tachycardia and blood pressure increased anxiety and incidence of arrhythmias, These effects are shown to
happen in the peri-induction and emergence phases of anesthesia and increased
noise can potentially worsen them. Our study’s aim is to eliminate the
noise exposure to the patients in the OT by using the noise cancellation
headphones. We hypothesize that noise cancellation with CLADS will reduce the
propofol dosage required for the induction when compared with conventional CLADS. The
study is prospective randomized, non-inferiority clinical trial with open label
and blinding to data analyst. Our participants are ASA 1 And 2 patients
reporting to Nehru hospital and Nehru Hospital Extension Operation Theatres,
PGIMER for non-cardiac surgeries. The primary outcome is the difference in the
propofol dosage used for induction (BIS 50) between Quiet CLADS (noise)
cancellation + CLADS) and conventional CLADS. The secondary outcome includes
estimated effect site concentration of propofol, Time required to achieve BIS
50, total propofol dose used, incidence of hypertension, tachycardia during
intubation, incidence of hypotension, bradycardia, and their respective rescue
medication and the recovery time during intraoperative period. In postoperative
period PONV, NRS pain and CAM ICU scores are collected at 30 minutes, 6th,
12the 24th hour. The patient is taken inside the OT with
noise-canceling headphones attached. Standard monitors attached with BIS monitoring
and the patient is induced with CLADS (fentanyl and propofol). The headphones
are removed before the skin closure. The intraoperative and postoperative
outcomes are noted as per the above-mentioned protocol. |