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CTRI Number  CTRI/2023/06/053644 [Registered on: 07/06/2023] Trial Registered Prospectively
Last Modified On: 02/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Protective role of sedative agents on heart in open heart surgeries. 
Scientific Title of Study   Effect of dexmedetomidine on myocardial protection during propofol based total intravenous anaesthesia in patients undergoing open heart surgery: A randomised double-blinded controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manoj Kamal 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur  
Address  All India Institute of Medical Sciences (AIIMS), Jodhpur Department of Anaesthesiology and critical care HI Area Phase II, Basni

Jodhpur
RAJASTHAN
342005
India 
Phone  9414084584  
Fax    
Email  geetamanoj007@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Manoj Kamal 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur  
Address  All India Institute of Medical Sciences (AIIMS), Jodhpur Department of Anaesthesiology and critical care HI Area Phase II, Basni

Jodhpur
RAJASTHAN
342005
India 
Phone  9414084584  
Fax    
Email  geetamanoj007@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Harshada Sharma 
Designation  PG Student 
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Anaesthesiology and critical care All India Institute of Medical Sciences Jodhpur HI Area Phase II Basni

Jodhpur
RAJASTHAN
342005
India 
Phone  8894848453  
Fax    
Email  harshada.sharma799@gmail.com  
 
Source of Monetary or Material Support  
AIIMS JODHPUR  
 
Primary Sponsor  
Name  AIIMS JODHPUR  
Address  All India Institute of Medical Sciences (AIIMS) HI Area Phase II, Basni Jodhpur, Rajasthan , 342005 
Type of Sponsor  Research institution and hospital 
 
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 
Manoj Kamal   AIIMS JODHPUR   All India Institute of Medical Sciences (AIIMS) 3rd floor, DnT block, HI Area Phase II, Basni, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN 
9414084584

geetamanoj007@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   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  Addition of dexmedetomidine infusion to propofol based TIVA   In addition to propofol infusion ( 10mg/kg/hr) , dexmedetomidine infusion will be started ( 0.5mcg/kg/h over 10 min loading dose and then continuous infusion at 0.4 mcg/kg/hr) in open heart surgeries to see the effect on Troponin- I levels. 
Comparator Agent  Effect of propofol based TIVA on Troponin - I   Anaesthesia will be maintained with continuous infusion of propofol throughout intra-operative period at 10mcg/kg/hr to maintain BIS between 40-60. Infusion rates will be titrated to maintain BIS between 40-60. Troponin I levels are checked in pre-operative period, at 6hr, 24hrs and 48hrs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 years and above
2. Belonging to American Society of Anaesthesiologists (ASA) physical status II - IV and scheduled for open heart surgery.
3. Patients of either sex.
4. Scheduled for elective open heart surgery. 
 
ExclusionCriteria 
Details  1. Emergency surgery
2. Cross-clamp time more than 120 minutes
3. Combined CABG and valvular heart surgery
4. Prior cardiac surgery
5. Left ventricular ejection fraction <0.5
6. Patients having chronic renal/ liver/ pulmonary disease
7. Preoperative mechanical ventilation  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Troponin I   24hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare MB isoenzyme levels between both groups.
2. To compare need for inotropic and vasopressor support using Vaso-inotropic score(VIS) between both groups.
3. To compare intra-operative propofol consumption
4. To compare length of ICU stay.
5. To compare length of hospital stay.
6. To compare the survival (at 30 days)
7. Occurrence of major cardiovascular events within 3 postoperative days. 
First 72hours postoperative hours 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   10/06/2023 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On personal request through mail at geetamanoj007@yahoo.co.in

  6. For how long will this data be available start date provided 10-07-2023 and end date provided 31-03-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Pre-anaesthetic evaluation will be done for all patients, a day before surgery. All patients will be thoroughly explained about the procedure and informed consent will be obtained. The standard instruction of fasting will be given to all patients (2 hours for clear liquids and 6 hours for semisolid and solid food).
On the day of surgery, in operating room, routine monitoring including electrocardiogram, peripheral oxygen saturation, non-invasive blood pressure and Bi-spectral (BIS) electrode will be attached and baseline vitals will be recorded. A peripheral intravenous cannula (16 G) and right radial arterial cannula (18 G) will be secured under local anaesthesia.
Pre-operative cardiac Troponin I levels sent.
All patients will be induced with midazolam 0.05 mg/kg, fentanyl 10 μg/kg and Propofol at the rate 2mg/kg. Rocuronium 1-1.2 mg/kg will be given to facilitate tracheal intubation. Mechanical ventilation will be controlled using 50% oxygen with a tidal volume of 6–8 ml/kg. A normal end tidal carbon dioxide pressure (35–45 mmHg) will be adjusted the respiratory frequency at 12–16 breaths/min. Transesophageal echocardiograph and urine output will be monitored.
In the propofol group (group P), anaesthesia will be maintained with propofol 10 mg/kg/h throughout the intraoperative period. In Propofol and dexmedetomidine (group PD), the anaesthesia will be maintained with dexmedetomidine 0.5 mcg/kg bolus over 10 min than 0.4 mcg/kg/min throughout the surgical procedure and propofol at infusion rate of 2–10 mg/kg/h.
In both groups the muscle relaxation will be maintained with Rocuronium 0.1 mg/kg at every 60 minutes and the depth of anaesthesia will be maintained between 40-60.
The cold cardioplegia solution will be prepared by magnesium sulfate 2.5 g, potassium chloride 2 g, and sodium bicarbonate 0.5 g in 500 ml physiologic saline, and administered into the aortic root every 30 min. The CPB procedure and surgical techniques will be under moderate hypothermia (32-34 °C) were standardized. The CPB prime volume, 1000–1500 ml calculated by patient’s weight, containing balanced salt solution, mannitol, and. The perfusion pressure (50–70 mmHg) will be maintained by a continuous non-pulsatile blood-flow rate of 2.0–2.5 l/min/m�’2 during CPB. All patients will be weaned off CPB by the support of epinephrine and norepinephrine. The patients will be withdrawn from the study if the CPB time was less 60 min or over 240 min or repeated CPB will be more than two times.
After completion of surgery the anaesthetic drugs will be discontinued and patients will be shifted to ICU. In the ICU, the vasopressor requirement will be recorded and further blood sample for biochemical marker will be sent at 6 hours, 24 hours and 72 hours.

 
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