| 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. |
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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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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Source of Monetary or Material Support
|
|
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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 |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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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 |
|
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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 |
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Troponin I |
24hours |
|
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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 |
|
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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 |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - On personal request through mail at geetamanoj007@yahoo.co.in
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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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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