| CTRI Number |
CTRI/2025/10/096173 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| 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
|
The effect of mild Hypercapnia in cerebral oxygen saturation in patients undergoing off pump coronary artery bypass grafting |
|
Scientific Title of Study
|
A randomized controlled clinical study to compare the effects of Normocapnia versus mild hypercapnia on cerebral oxygen saturation in patients undergoing off pump coronary artery bypass grafting at SMS Hospital , Jaipur |
| 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 Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and attached hospital , Jaipur |
| Address |
Department of Anaesthesiology Sawai Man Singh Medical College and attached hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and attached hospital , Jaipur |
| Address |
Department of Anaesthesiology Sawai Man Singh Medical College and attached hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Parwani |
| Designation |
Resident doctor |
| Affiliation |
SMS Medical College and attached hospital , Jaipur |
| Address |
Department of Anaesthesiology Sawai Man Singh Medical College and attached hospital
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9982547107 |
| Fax |
|
| Email |
parwanineha5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Sawai Man Singh Medical College and attached hospital , Jaipur, Rajasthan , 302004, INDIA |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia Sawai Man Singh Medical College and attached hospital Jaipur |
| Address |
Department of anaesthesia Sawai Man Singh Medical College and attached hospital , Jaipur , 302004, Rajasthan , INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjum Saiyed |
Sawai Man Singh Medical College and attached hospital , Jaipur |
Department of anaesthesia Sawai Man Singh Medical College and attached hospital
Jaipur
RAJASTHAN |
9214021930
dranjumsaiyed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients receiving targeted mild hypercapnia (PaCO2 45-55 mm Hg) during off pump coronary artery bypass grafting surgery. |
Nil |
| Comparator Agent |
Patients receiving targeted normocapnia (PaCO2 35-45 mm Hg). |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Informed written consent
2. Patients of either sex age between 35 -70 years posted for off-pump CABG
3. Ejection fraction more than 40%
4. ASA Grade 2 - 4
|
|
| ExclusionCriteria |
| Details |
1. Patient having preexisting cognitive dysfunction.
2. Known case of chronic obstructive pulmonary disease (COPD).
3. Redo CABG surgeries.
4. Associated valvular lesions .
5. Preexisting neurological disorder (History of Stroke).
6. The patients who required intra- aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) before leaving the operating room.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change in intraoperative regional cerebral oxygen saturation (rSO2) on the right, left, and mean sides between the two groups—targeted mild hypercapnia and targeted normocapnia—during off-pump coronary artery bypass grafting surgery |
T0 Baseline ( Before Induction)
T1 (After induction)
T2 After LIMA Harvesting
T3 At each grafting distal site
T4 At each grafting proximal site
T5 After protamine administration
After shifting to ICU
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in hemodynamic parameters (Heart Rate, Systolic & Diastolic Blood Pressure, Mean Arterial Pressure, Central Venous Pressure)
|
T0 Baseline (before induction)
T1 After induction
T2 After Left Internal Mammary Artery (LIMA) harvesting
T3 At each grafting distal site
T4 At each grafting proximal site
T5 After protamine administration |
| Arterial Blood Gas Values |
T0 Baseline (before induction)
T1 After induction
T2 After Left Internal Mammary Artery (LIMA) harvesting
T3 At each grafting distal site
T4 At each grafting proximal site
T5 After protamine administration
After shifting to the Intensive Care Unit (ICU) |
| Duration of mechanical ventilation |
|
| Standardized Mini-Mental State Examination (SMMSE) scores postoperatively for cognitive assessment |
1. Preoperatively (before surgery)
2. 8 hours after extubation
3. 12 hours after extubation
4. 24 hours after extubation |
| Length of ICU and Hospital Stay |
|
| Any complications or side effects observed during the study |
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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="0"
Months="3"
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
|
This study is a prospective, randomized, parallel group, active controlled clinical trial at SMS Hospital comparing the effects of targeted mild hypercapnia (PaCO2 45-55 mmHg) versus targeted normocapnia (PaCO2 35-45 mmHg) on cerebral oxygen saturation and postoperative cognitive function in patients undergoing off pump coronary artery bypass grafting. The primary outcome is the change in intraoperative regional cerebral oxygen saturation measured at multiple surgical time points. Secondary outcomes include hemodynamic parameters, arterial blood gas values, duration of mechanical ventilation, standardized mini-mental state examination scores, and length of ICU/hospital stay. Randomization is via sequentially numbered, sealed, opaque envelopes, and the study is open label without blinding. The target sample size is 66 patients. The assessments occur intraoperatively and postoperatively up to 24 hours after extubation to evaluate cerebral oxygenation and cognitive function. |