Dexmedetomidine Enhancing the Recovery After Cardiac Surgery

Dexmedetomidine-based Enhanced Recovery After Cardiac Surgery Improves Outcome Regarding Analgesia, Sleep Disorders, and Postoperative Delirium

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.

Study Overview

• Status: Completed
• Conditions: Post-cardiac Surgery
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Lidocain; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Qalyoubia
    • Banhā, El Qalyoubia, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group F	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.
Active Comparator: Group D	Drug: 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.; Drug: Lidocain; Lidocaine (LID) loading dose (1 mg/kg) followed by a continuous infusion till 24 h PO as 1.5 mg/kg/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant Enhancement of Post Operative Recovery Levels After Dexmedetomidine Administration in Cardiac Surgery.	Post-operative recovery was measured on 3 levels: Confusion, Sleep Quality, and Delirium. The study focused primarily on postoperative delirium through the Delirium Index, a 7-item questionnaire that graded the severity of delirium in patients with or without dementia. These seven items assess disorders of attention, thought, consciousness, orientation, memory, perception, and psychomotor activity. Each item is scored on a 0-3 scale, with zero indicating the absence of disturbance, while 1-3 indicates mild, moderate, and severe disturbance of the assessed function for a total score ranging between 0 and 21, and higher scores indicate higher delirium severity.	3 months

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Lidocaine; Dexmedetomidine; Fentanyl
• Other Study ID Numbers: RC 17-11-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No