CTRI/2022/04/042240 [Registered on: 28/04/2022] Trial Registered Prospectively
Last Modified On:
26/04/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Preventive
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Comparison of the relationship between cerebral oxygen saturation and mild hypercapnia in patients undergoing off- pump Coronary Artery Bypass Grafting
Scientific Title of Study
Prospective randomized control trial to compare the relationship between cerebral oxygen saturation and mild hypercapnia in patients undergoing off- pump Coronary Artery Bypass Grafting
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Chanchal Bhandari
Designation
Department of Cardiac Anesthesia, DM Resident 1st year
Affiliation
U.N.Mehta Institute of Cardiology and Research Center
Address
U. N. Mehta Institute of Cardiology and Research Center, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India U. N. Mehta Institute of Cardiology and Research Center, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India Ahmadabad GUJARAT 380016 India
Phone
22682092
Fax
Email
chanchal.bhandari31@gmail.com
Details of Contact Person Scientific Query
Name
Chanchal Bhandari
Designation
Department of Cardiac Anesthesia ,DM Resident 1st year
Affiliation
U.N.Mehta Institute of Cardiology and Research Center
Address
U. N. Mehta Institute of Cardiology and Research Center, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India U. N. Mehta Institute of Cardiology and Research Center, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India Ahmadabad GUJARAT 380016 India
Phone
9404552355
Fax
Email
chanchal.bhandari31@gmail.com
Details of Contact Person Public Query
Name
Chanchal Bhandari
Designation
Department of Cardiac Anesthesia, DM Resident 1st year
Affiliation
U.N.Mehta Institute of Cardiology and Research Center
Address
U. N. Mehta Institute of Cardiology and Research Center, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India U. N. Mehta Institute of Cardiology and Research Center, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India Ahmadabad GUJARAT 380016 India
Phone
9404552355
Fax
Email
chanchal.bhandari31@gmail.com
Source of Monetary or Material Support
U.N.Mehta Institute of Cardiology and Research center
Primary Sponsor
Name
UNMICRC
Address
U.N.Mehta Institute of Cardiology and Research center
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
Dr Hemang Gandhi
U.N.Mehta Institute of Cardology and research center
Department of Cardiac anesthesia, U. N. Mehta Institute of Cardiology and Research Center, Civil Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India Ahmadabad GUJARAT
9404552355
drhemang77@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
InstitutionalEthicsCommitteeUNMICRC
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: I708||Atherosclerosis of other arteries, (2) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
targeted mild hypercapnia (TMH)
A thorough pre-anaesthetic check-up will be done prior to surgery. Patients will be educated briefly about the anaesthesia procedure. All patients will be kept nil by mouth for 6 hours prior to surgery. Written and informed consent will be taken from all patients participating in the study. Patient’s confidentiality will be maintained at all times and patients will be duly informed about the study through patient information sheet before signing the informed consent.
On arrival to the operating room, monitors including five lead electrocardiogram, pulse oximeter , capnography will be connected. An intravenous access with 16G/18G cannula and a radial arterial line under local anaesthesia shall be achieved for IABP monitoring and for ABG sampling. Prior to induction of anaesthesia, cerebral oximetry sensors placed bilaterally over the fronto temporal area, and the baseline rSO2 values will be measured. The patient shall be given Inj Midazolam 0.3mg/kg, Inj Fentanyl 5-10 microgram/kg body weight and Inj vecuronium 0.1 mg/kg body weight shall be used for induction. The patient will be pre oxygenated for 3 minutes and then intubated with appropriate size endotracheal Tube. A 7 fr central line will be secured for administration of drugs (infusion of Dobutamine /Milirinone, Noradrenaline, Nitroglycerine) and for CVP monitoring. Anaesthesia will be maintained with fentanyl and sevoflurane in oxygen, air mixture. Muscle relaxant will be maintained with vecuronium boluses.
After induction patient will be randomised to either targeted mild hypercapnia (TMH) group. Minute ventilation will be adjusted to maintain an end tidal carbon dioxide concentration of 45-55 mm Hg just before LIMA harvesting in targeted mild hypercapnia (TMH) group . Inj heparin 100 units/kg to maintain ACT level around 250.The fluid will be given as per CVP . The ionotrope will be decided by pre op or intra op condition of heart and hemodynamics.
The cerebral oxygen saturation (rSO2), heart rate (HR), Mean Arterial Pressure (MAP), end tidal CO2, , peripheral oxygen saturation (SPO2) monitoring done as baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU. ABG will be taken before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting to ICU, 4,12, 24 hrs and 48 hrs after extubation. The Standardized Mini-Mental State Examination (SMMSE) will be performed preoperatively, at 8, 12 &24 hrs postextubation.
Intervention
targeted normocapnia (TN) group
A thorough pre-anaesthetic check-up will be done prior to surgery. Patients will be educated briefly about the anaesthesia procedure. All patients will be kept nil by mouth for 6 hours prior to surgery. Written and informed consent will be taken from all patients participating in the study. Patient’s confidentiality will be maintained at all times and patients will be duly informed about the study through patient information sheet before signing the informed consent. On arrival to the operating room, monitors including five lead electrocardiogram, pulse oximeter , capnography will be connected. An intravenous access with 16G/18G cannula and a radial arterial line under local anaesthesia shall be achieved for IABP monitoring and for ABG sampling. Prior to induction of anaesthesia, cerebral oximetry sensors placed bilaterally over the fronto temporal area, and the baseline rSO2 values will be measured. The patient shall be given Inj Midazolam 0.3mg/kg, Inj Fentanyl 5-10 microgram/kg body weight and Inj vecuronium 0.1 mg/kg body weight shall be used for induction. The patient will be pre oxygenated for 3 minutes and then intubated with appropriate size endotracheal Tube. A 7 fr central line will be secured for administration of drugs (infusion of Dobutamine /Milirinone, Noradrenaline, Nitroglycerine) and for CVP monitoring. Anaesthesia will be maintained with fentanyl and sevoflurane in oxygen, air mixture. Muscle relaxant will be maintained with vecuronium boluses. After induction patient will be randomised to targeted normocapnia (TN) group. Minute ventilation will be adjusted to maintain an end tidal carbon dioxide concentration just before LIMA harvesting 35-40 mm Hg in targeted normocapnia (TN) group. Inj heparin 100 units/kg to maintain ACT level around 250.The fluid will be given as per CVP . The ionotrope will be decided by pre op or intra op condition of heart and hemodynamics. The cerebral oxygen saturation (rSO2), heart rate (HR), Mean Arterial Pressure (MAP), end tidal CO2, , peripheral oxygen saturation (SPO2) monitoring done as baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU. ABG will be taken before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting to ICU, 4,12, 24 hrs and 48 hrs after extubation. The Standardized Mini-Mental State Examination (SMMSE) will be performed preoperatively, at 8, 12 &24 hrs postextubation.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
OPCABG, EF>40%
ExclusionCriteria
Details
PATIENTS ON ECMO OR IABP, REDO CABG SURGERY
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To investigate the relationship between mild hypercapnia and regional cerebral oxygen saturation (rSo2) during off -pump CABG.
baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU?
Secondary Outcome
Outcome
TimePoints
To observe intraoperative pH, bicarbonate concentration, serum potassium concentration and incidence of postoperative cognitive dysfunction.
baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine, after shifting in ICU, 4 hrs, 12 hrs and 24 hrs
Target Sample Size
Total Sample Size="100" Sample Size from India="100" 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)
01/05/2022
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 - NO
Brief Summary
A thorough pre-anaesthetic check-up will be done prior to surgery. Patients will be educated briefly about the anaesthesia procedure. All patients will be kept nil by mouth for 6 hours prior to surgery. Written and informed consent will be taken from all patients participating in the study. Patient’s confidentiality will be maintained at all times and patients will be duly informed about the study through patient information sheet before signing the informed consent.
On arrival to the operating room, monitors including five lead electrocardiogram, pulse oximeter, capnography will be connected. An intravenous access with 16G/18G cannula and a radial arterial line under local anaesthesia shall be achieved for IABP monitoring and for ABG sampling. Prior to induction of anaesthesia, cerebral oximetry sensors placed bilaterally over the fronto temporal area, and the baseline rSO2 values will be measured. The patient shall be given Inj Midazolam 0.3mg/kg, Inj Fentanyl 5-10 microgram/kg body weight and Inj vecuronium 0.1 mg/kg body weight shall be used for induction. The patient will be pre oxygenated for 3 minutes and then intubated with appropriate size endotracheal Tube. A 7 fr central line will be secured for administration of drugs (infusion ofDobutamine /Milirinone, Noradrenaline, Nitroglycerine) and for CVP monitoring. Anaesthesia will be maintained with fentanyl and sevoflurane in oxygen, air mixture. Muscle relaxant will be maintained with vecuronium boluses.
After induction patient will be randomised to either targeted mild hypercapnia (TMH) or targeted normocapnia(TN) group. Minute ventilation will be adjusted to maintain an end tidal carbon dioxide concentration of 45-55 mm Hgjust before LIMA harvesting in targeted mild hypercapnia (TMH) group and 35-40 mm Hg in targeted normocapnia (TN) group. Inj heparin 100 units/kg to maintain ACT level around 250.The fluid will be given as per CVP . The ionotrope will be decided by pre op or intra op condition of heart and hemodynamics.
The cerebral oxygen saturation (rSO2), heart rate (HR), Mean Arterial Pressure (MAP), end tidal CO2, , peripheral oxygen saturation (SPO2) monitoring done as baseline i.e before induction, after LIMA harvesting, at each grafting proximal and distal, after protamine,after shifting in ICU. ABG will be taken before induction, after LIMA harvesting, at each grafting proximaland distal, after protamine, after shifting to ICU, 4,12, 24 hrs and 48 hrs after extubation. The Standardized Mini-Mental State Examination (SMMSE) will be performed preoperatively, at 8, 12 & 24 hrs post-extubation.