| CTRI Number |
CTRI/2024/11/077113 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Role of Noise Cancellation in Reducing Pain Medication After Open Heart Surgery |
|
Scientific Title of Study
|
Effect of Noise Cancellation on Post Operative Analgesic Requirement in patients undergoing Open Heart Surgery- A Randomized Clinical Trial |
| 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 Rakesh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical care All India Institute Of Medical Sciences(AIIMS)
Basni Industrial Area Phase-2
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
946042922 |
| Fax |
|
| Email |
drrakeshspmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical care All India Institute Of Medical Sciences(AIIMS)
Basni Industrial Area Phase-2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
946042922 |
| Fax |
|
| Email |
drrakeshspmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Nager |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences Jodhpur |
| Address |
Department of Anaesthesiology and Critical care All India Institute Of Medical Sciences(AIIMS)
Basni Industrial Area Phase-2
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7988029353 |
| Fax |
|
| Email |
v526126@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan, India. Pincode-342005 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Jodhpur |
| Address |
All India Institute Of Medical Sciences(AIIMS)
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajastha. Pincode- 342005 |
| 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 Rakesh |
All India Institute of Medical Sciences Jodhpur |
Department of Anaesthesiology and Critical Care, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN |
9460429221
drrakeshspmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ETHICS COMMITTEE AIIMS Jodhpur |
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 Cancellation Headphones |
Noise cancellation headphones will be put in the study group and noise cancellation will be done |
| Comparator Agent |
Normal Headphones |
Normal headphones will be put in the control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 to 70 years belonging to ASA II or III and posted for elective Cardiac Surgery with midline sternotomy |
|
| ExclusionCriteria |
| Details |
Patients who refuse to participate in the study
Emergency surgery
Patients who received any kind of regional block for postoperative pain
Patients with cognitive deficits making them inefficient to use IV PCA pump
Patient with LVEF less than forty percent
Preoperative cardiac support (IV inotropes or vasoconstrictors)
Morbid obesity
Patients with liver and renal dysfunction
Patients of opium addict
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare Post operative opioid consumption during the first 24 hours after surgery |
24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare postoperative Visual Analog Scale (VAS) pain score at rest and on cough during the first 24 hours (2, 6, 12, 18 and 24 h in intensive care unit)
2. To compare the time to extubation in both the groups
3. To compare patient satisfaction scores |
First 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Moderate to severe pain is experienced by the patient under going midline sternotomy. Poorly controlled pain is associated with sympathetic nervous system activation and increased hormonal response to stress. All these lead to postoperative adverse events, including MI, cardiac arrhythmias, hypercoagulability, PPC. Currently, systemic opioids and NSAIDs are the commonly used practices for postoperative pain management after cardiac surgery. Recently, the focus has increasingly been on non-pharmacological and non-invasive modalities of analgesia (acupuncture, educational videos music, white noise ) Correlation has been found between intraoperative noise levels and postoperative pain in clinical settings. Research Question- Does Noise isolation decrease opioid requirements in patients undergoing cardiac surgery Hypothesis- Noise isolation decreased postoperative pain and opioid requirements in patients undergoing cardiac surgery under general anesthesia
|