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CTRI Number  CTRI/2024/10/075359 [Registered on: 16/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Use of Dexmedetomedine to complement the benefit of total anesthetic stability in patients who are undergoing heart surgeries. 
Scientific Title of Study   Dexmedetomedine as a perioperative adjunct in patients undergoing cardiac surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EC/OA-46/2024 Version 2.0 18/09/2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjeeta Umbarkar 
Designation  Professor 
Affiliation  Seth GS Medical collage and KEM Hospital 
Address  Department of Cardiac Anesthesia Room no 305, ground floor CVTC building Seth GSMC and KEM hospital Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  sanjeeta69@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjeeta Umbarkar 
Designation  Professor 
Affiliation  Seth GS Medical college and KEM Hospital 
Address  Department of Cardiac Anesthesia Room no 305, ground floor CVTC building Seth GSMC and KEM hospital Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9323273435  
Fax    
Email  sanjeeta69@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjeeta Umbarkar 
Designation  Professor 
Affiliation  Seth GS Medical college and KEM Hospital 
Address  Department of Cardiac Anesthesia Room no 305, ground floor CVTC building Seth GSMC and KEM hospital Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9323273435  
Fax    
Email  sanjeeta69@yahoo.com  
 
Source of Monetary or Material Support  
Seth GS Medical college and KEM Hospital,Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012, India 
 
Primary Sponsor  
Name  Dr Sanjeeta Umbarkar 
Address  Department of Cardiac Anesthesia Room no 305, ground floor CVTC building Seth GSMC and KEM hospital Parel Mumbai 400012 
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 Sanjeeta Umbarkar  Seth GS Medical College and KEM Hospital  Department of Cardiac Anesthesia Room no 305, ground floor CVTC building Seth GSMC and KEM hospital Parel Mumbai 400012
Mumbai
MAHARASHTRA 		 9323273435

sanjeeta69@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-III  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, (2) ICD-10 Condition: I01||Rheumatic fever with heart involvement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidne at 05 ug/kg/hr  This was the adjuvant sedative given in these patients. This will be given INTRAVENOUSLY, at 5ug/kg/hr. This will be given from the onset of induction of anesthesia till the end of surgery throughout at the same dosage. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing valvular cardiac surgery 
 
ExclusionCriteria 
Details  Preoperative treatment with morphine or its derivatives including tramadol in the 15 days preceding the inclusion visit
Pre-existing high-degree conduction disorder
Oxygen therapy prior to inclusion
Heart failure with LVEF less than 40 percent
BMI more than 35
Myocardial suffering in the 5 days preceding surgery
Patient in shock
Known adrenal insufficiency and or long-term systemic corticosteroid treatment equivalent to hydrocortisone hemisuccinate more than 20 mg per day
Long-term non-invasive ventilation including for obstructive sleep apnea syndrome
Any antecedent or active practices of drug addiction
Contraindication to one of the experimental and or nonexperimental treatment like dexmedetomidine lidocaine dexamethasone ketamine remifentanil or morphine
Acute cerebrovascular pathology
Severe hepatic insufficiency with factor V level less than 50 percent
Pre-existing cognitive disorders
Pregnant or parturient or breastfeeding woman
Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection under guardianship or guardianship
Patient participating in another drug trial or having participated in another drug trial within 1 month before randomization
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effects of Dexmedetomidine on hemodynamics and depth of anesthesia in patients undergoing valvular heart replacement surgeries  Baseline
post induction
after Sternotomy
after pericardiotomy
5 minutes after protamine
administration
end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess duration of ICU stay & incidences of postoperative complications which received Dexmedetomidine perioperatively  Admission to ICU after surgery
upto
30 days status of patient 
 
Target Sample Size   Total Sample Size="153"
Sample Size from India="153" 
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)   26/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Dexmedetomidine  is a potent, highly selective alpha-2 adrenoceptor agonist with sedative, analgesic, anxiolytic, anti-sympathetic and opioid-sparing properties. It is known to act as a useful adjunct by reducing the needs for opioids, inhalational agents as well as intravenous agents. It has been shown to reduce the anaesthetic and opioid requirement in patients undergoing cardiac surgeries. It has also proven to provide hemodynamic stability,owing to its effect in controlling the adrenocortical as well as cardiac function in patients undergoing vascular surgery, a patient population, who have a high incidence of coronary artery diseases. In addition, it leads to a decrease in plasma levels of cortisol, epinephrine, norepinephrine and serotonin and provides cardioprotective effects. It, thus, appears to be a useful agent during cardiac surgery. The present study is conducted to assess the efficacy of Dexmedetomidine  when used as an adjunct in Cardiac surgeries on hemodynamic stability, maintenance of depth of anesthesia and post-operative outcomes.

 

The data obtained from patient records would include

1.     Patient demographics including diagnosis, surgery and ASA grading.

2.     Premedications given.

3.     Baseline hemodynamics like Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values.

4.     Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values post induction.

5.     Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values after Sternotomy.

6.     Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values after pericardiotomy.

7.     Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values 5 minutes after protamine administration.

8.     Heart rate, Mean Arterial Pressure, Central Venous Pressure, Near Infrared Spectroscopy and Entropy (SE, RE) values at the end of surgery.

9.     Post operative time of extubation.

10.  Post Operative events with their cause and time would be noted namely reintubation, reoperation, Atrial fibrillation, acute kidney injury, Type 1 neurological injury(defined as new episode of motor deficit, coma, seizure or encephalic lesion documented by cranial computed tomography or magnetic resonance imaging), ICU readmission, ICU length of stay, 30- day mortality.

 

 
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