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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  
NIL 
 
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  
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 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  
Status 
Not Applicable 
 
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.

 
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