The effect of mild Hypercapnia in cerebral oxygen saturation in patients undergoing off pump coronary artery bypass grafting

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096173

Enrollment

Registered

2025-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 4- Measurement and Monitoring

Interventions

Intervention1: Patients receiving targeted mild hypercapnia (PaCO2 45-55 mm Hg) during off pump coronary artery bypass grafting surgery.: Nil Control Intervention1: Patients receiving targeted normoca

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 surgeryTimepoint: 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	—

Measure

Time frame

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 surgeryTimepoint: 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

Measure	Time frame
Changes in hemodynamic parameters (Heart Rate, Systolic & Diastolic Blood Pressure, Mean Arterial Pressure, Central Venous Pressure) Timepoint: 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 ValuesTimepoint: 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 ventilationTimepoint: ;Standardized Mini-Mental State Examination (SMMSE) scores postoperatively for cognitive assessmentTimepoint: 1. Preoperatively (before surgery) 2. 8 hours after extubation 3. 12 hours after extubation 4. 24 hours after extubation;Length of ICU and Hospital StayTimepoint: ;Any complications or side effects observed during the studyTimepoint:	—

Measure

Time frame

Changes in hemodynamic parameters (Heart Rate, Systolic & Diastolic Blood Pressure, Mean Arterial Pressure, Central Venous Pressure) Timepoint: 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 ValuesTimepoint: 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 ventilationTimepoint: ;Standardized Mini-Mental State Examination (SMMSE) scores postoperatively for cognitive assessmentTimepoint: 1. Preoperatively (before surgery) 2. 8 hours after extubation 3. 12 hours after extubation 4. 24 hours after extubation;Length of ICU and Hospital StayTimepoint: ;Any complications or side effects observed during the studyTimepoint:

—

Countries

India

Contacts

Public ContactDr Neha Parwani

SMS Medical College and attached hospital , Jaipur

dranjumsaiyed@gmail.com9214021930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026