Dexmedetomidine Enhancing the Recovery After Cardiac Surgery

NCT06907277 | Completed

• 1 other identifier: RC 17-11-2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group D

ACTIVE COMPARATOR

Drug: Dexmedetomidine; Drug: Lidocain

Group F

ACTIVE COMPARATOR

Drug: Fentanyl

Interventions

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.

Group D

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.

Group F

Lidocain DRUG

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

Group D

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Pain & ICU

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: August 30, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 31, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

EG (1)