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Completed

NCT Number: NCT06907277

Dexmedetomidine Enhancing the Recovery After Cardiac Surgery

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.

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Key information

Conditions

Post-cardiac Surgery

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

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.

Fentanyl

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.

Lidocain

Drug

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

Primary outcomes

  1. Significant Enhancement of Post Operative Recovery Levels After Dexmedetomidine Administration in Cardiac Surgery.

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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