Dexmedetomidine Enhancing the Recovery After Cardiac Surgery

NCT ID: NCT06907277

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2025-01-31

Brief Summary

Enhanced Recovery After Surgery (ERAS) aims to facilitate a quicker and smoother recovery period following surgical procedures. The implementation of these protocols may lead to patients returning to their daily activities sooner, experiencing greater satisfaction with their care, and potentially encountering fewer complications, ultimately contributing to shorter hospital stays. However, a common challenge in the postoperative phase is postoperative delirium(POD). This complication can lead to both immediate and long-term cognitive impairments, negatively impact overall health outcomes, and increase the financial burden on the healthcare system. Interestingly, dexmedetomidine, known as DXM, is a medication that selectively targets certain receptors in the brain and offers sedative properties with minimal impact on breathing. This characteristic is noteworthy because it may help regulate sleep patterns and support the preservation of cognitive function during the recovery period.

Conditions

Post-cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group D

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine (DXM) loading dose of 0.6 µg/kg followed by DXM infusion given at a rate of 0.4 ml/kg/h and was provided as 0.15 µg/kg/h for 24-h PO.

Lidocain

Intervention Type: DRUG

Lidocaine (LID) loading dose (1 mg/kg) followed by a continuous infusion till 24 h PO as 1.5 mg/kg/h.

Group F

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

A bolus of fentanyl 5 µg/kg followed by an intraoperative (IO) fentanyl infusion of 3-5 µg/kg/h that was continued as PO analgesia for 24 hours in a dose of 0.3 µg/kg/h.

Interventions

Dexmedetomidine

Dexmedetomidine (DXM) loading dose of 0.6 µg/kg followed by DXM infusion given at a rate of 0.4 ml/kg/h and was provided as 0.15 µg/kg/h for 24-h PO.

Intervention Type: DRUG

Fentanyl

A bolus of fentanyl 5 µg/kg followed by an intraoperative (IO) fentanyl infusion of 3-5 µg/kg/h that was continued as PO analgesia for 24 hours in a dose of 0.3 µg/kg/h.

Intervention Type: DRUG

Lidocain

Lidocaine (LID) loading dose (1 mg/kg) followed by a continuous infusion till 24 h PO as 1.5 mg/kg/h.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients of American Society of Anesthesiologists Classification (ASA) grade II-III;
• Patients who were planned to have Coronary Artery Bypass Graft (CABG);

Exclusion Criteria

• Patients with preoperative high risk for getting Post Operative Delirium or sleep disorders,
• Patients with American Society of Anesthesiologists Classification (ASA) grade>III;
• Patients with heart failure, left ventricle ejection fraction of <25%,
• Patients with uncontrolled diabetes mellitus, coagulopathy, or history of uncompensated renal or hepatic diseases

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abd ElRahman Hammed

Assistant Lecturer of Anesthesia, Pain & ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University

Banhā, El Qalyoubia, Egypt

Countries

Egypt

Other Identifiers

RC 17-11-2024

Identifier Type: -

Identifier Source: org_study_id