| CTRI Number |
CTRI/2025/09/094724 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dexmedetomidine Nebulization to Improve Recovery After CABG Surgery |
|
Scientific Title of Study
|
An Observational Study on Effect of Dexmedetomidine Nebulization on postoperative Quality of Recovery in patients undergoing off-pump Coronary Artery Bypass Grafting |
| 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 Arya K S |
| Designation |
DNB Resident Department of Anaesthesia |
| Affiliation |
Fortis Hospitals Limited |
| Address |
Fortis Hospitals limited
154 Bannerghatta Road Opp IIMB Bangalore Fortis Hospitals limited
154 Bannerghatta Road Opp IIMB Bangalore Bangalore KARNATAKA 560076 India |
| Phone |
7892079654 |
| Fax |
|
| Email |
cl.researchfhbg1@fortishealthcare.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Priyanka Joshi |
| Designation |
Consultant, department of Anaesthesia |
| Affiliation |
Fortis Hospitals Limited |
| Address |
Fortis Hospitals limited
154 Bannerghatta Road Opp IIMB Bangalore Fortis Hospitals limited
154 Bannerghatta Road Opp IIMB Bangalore Bangalore KARNATAKA 560076 India |
| Phone |
9870412128 |
| Fax |
|
| Email |
priyankajoshi1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arya K S |
| Designation |
DNB resident, Department of Anaesthesia |
| Affiliation |
Fortis Hospitals Limited |
| Address |
Fortis Hospitals limited
154 Bannerghatta Road Opp IIMB Bangalore Fortis Hospitals limited
154 Bannerghatta Road Opp IIMB Bangalore Bangalore KARNATAKA 560076 India |
| Phone |
7892079654 |
| Fax |
|
| Email |
ksarya801@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Non-Sponsored Academic Project |
| Address |
Fortis Hospitals limited
154 Bannerghatta Road Opp IIMB Bangalore |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Arya K S |
Fortis Hospitals Limited |
Fortis Hospitals limited
154 Bannerghatta Road Opp IIMB Bangalore Bangalore KARNATAKA |
7892079654
cl.researchfhbg1@fortishealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Fortis Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine Nebulization |
Dexmedetomidine 1 mcg/kg in 5 ml NS every 12th hourly. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Elective OPCABG patients.
Age 40–75 years.
ASA II, III patients.
Consent to participate.
|
|
| ExclusionCriteria |
| Details |
1. Emergency surgery.
2. Severe hepatic or renal dysfunction.
3. AV block (Grade II/III) without pacemaker.
4. Chronic use of sedatives/opioids.
5. Allergy to dexmedetomidine.
6. Pre-existing psychiatric or neurological illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative Quality of Recovery Score using the QoR-40 Questionnaire at 24 and 48 hours post-extubation. |
Postoperative Quality of Recovery Score using the QoR-40 Questionnaire at 24 and 48 hours post-extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Hemodynamic parameters (HR, BP) at 6, 12, 18, 24 hours
•Postoperative opioid consumption in first 24 hours.
•ICU and hospital length of stay.
•Adverse events: bradycardia, hypotension, desaturation.
|
6, 12, 18, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="108" Sample Size from India="108"
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)
|
22/09/2025 |
| 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
|
· Coronary artery bypass graft (CABG) surgery
remains a very important procedure for patients with narrowed coronary arteries
either as a result of multiple vessel disease or following failed percutaneous
intervention. It basically involves replacing the narrowed portions of the
vessels with venous or arterial grafts.[1]
· Most of these patients have advanced heart
disease (New York Heart Association functional Class III and IV), in addition
to some co-existing diseases such as diabetes and chronic renal disease. This
makes intensive care after CABG a standard component of the treatment for most
of these patients. Factors such as age, gender, hospital admission prior to
surgery, the number of grafts and CPB time have variously been identified by
many authors as determinants of Intensive Care Unit (ICU) length of stay (LOS)
after CABG surgery. [1][2][3]. Long stay in the ICU has been found to result in
increased hospital mortality, poor long-term prognosis, high morbidity and
consequently increased cost and expenses. [4] .
· Nebulized dexmedetomidine offers a variable
alternative compared to IV dexmedetomidine, owing to drug deposition over a
greater surface area [nasal, buccal, respiratory mucosa], resulting in better
systemic absorption and prevention of postoperative delirium and agitation in
OPCABG patients[8][9]
·
Delirium is
experienced in 20% to 40% of the critically ill and up to 80% of mechanically
ventilated patients [1–4]. It is a confusional state that has been described as
a transient global disorder of cognition, awareness, and attention. It is
associated with prolonged hospital length of stay and time on MV, deterioration
in cognition, and increased morbidity and mortality causing additional
health-care expenses [4][5]. Its pathophysiological mechanisms are highly
heterogeneous—as perceived by the high number of risk factors —and have yet to
be fully understood.
Quality of recovery after anaesthesia is an
important measure of the early postoperative health status of patients. We
attempted to develop a valid and reliable measure of quality of recovery after
anaesthesia and surgery.[6]
· We will conduct a study of OPCABG procedures
done at the Fortis hospital, Bannerghatta, Bangalore, India over a 1 year
period to determine the efficacy of dexmedetomidine nebulization in quality of
recovery of these patients. |