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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. 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

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. 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

  6. 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.

  7. 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.

 
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