Effect of Remimazolam Versus Dexmedetomidine on the Incidence of Delirium After Elective Cardiac Surgery with Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial

Early Phase 1

Not yet recruiting

• Conditions: Delirium - Postoperative
• Interventions: Drug: Propofol Group 1; Drug: Dexmedetomidine Intervention; Drug: Remimazolam Intervention

• Registration Number: NCT06756178
• Lead Sponsor: Assiut University

Brief Summary

The study aims to improve the post-open heart surgery lifestyle and overall experience, as well as assess the incidence of delirium using Remimazolam and Dexmedetomidine.

Detailed Description

Delirium is an acute brain dysfunction characterized by an acute onset and fluctuating course of disturbance in attention, awareness, and cognition, It is the most common neurocognitive complication following cardiac surgery, with an incidence rate between 11% and 52%.

The occurrence of delirium correlates strongly with various short- and long-term poor outcomes following cardiac surgery, including prolonged ICU stay and hospitalization and increased risk of hospital readmission. Different risk factors contribute to delirium after cardiac surgery, including advanced age, pre-existing cognitive impairment, diabetes, history of stroke, type of surgery, extended CPB duration, and blood transfusion. Dexmedetomidine is a highly and potently selective α2-adrenoceptor agonist with anxiolytic, sedative, and analgesic properties. It has neuroprotective effects by reducing neuroinflammation, apoptosis, and blood-brain barrier injury via central α2A adrenoceptors, but it can cause hypotension and bradycardia.

Remimazolam, a new ultra-short-acting benzodiazepine, also has a faster onset of action and a higher safety profile. It was recently approved for procedural sedation and general anesthesia. Its metabolism is mainly induced by tissue esterase, independent of liver and kidney function, and its metabolites are inactive. In addition, flumazenil reverses the effects of Remimazolam in the event of adverse events, an advantage not available in non-benzodiazepines. The objective of this clinical trial is to evaluate the efficacy of Remimazolam compared with Dexmedetomidine for preventing postoperative delirium after cardiac surgery.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-25
• Last Update Submitted: 2024-12-25
• Study First Posted: 2025-01-01
• Last Update Posted: 2025-01-01
• Study Start: 2025-01-10
• Primary Completion: 2026-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• Age ≥18 years.
• Scheduled for cardiac surgery (CABG and/or valve replacement).
• Elective surgery

Exclusion Criteria

• Patients with known allergies to Remimazolam or Dexmedetomidine
• Refusal to participate.
• History of psychiatric or neurological conditions (schizophrenia, epilepsy, severe dementia, etc.).
• Preoperative inability to communicate (severe visual/auditory dysfunction, language barriers).
• Severe hepatic or renal dysfunction
• Cardiopulmonary bypass time not ≥ 120 minutes
• aortic clamping time not ≥ 90 minutes
• Emergency surgeries
• On preoperative mechanical ventilation and long sedation time
• reoperated patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 : propofol group	Propofol Group 1	Postoperative Use
Group 3: Dexmedetomidine Intervention	Dexmedetomidine Intervention	Postoperative Use
Group 2: Remimazolam Intervention	Remimazolam Intervention	Postoperative Use

Primary Outcome Measures

Name	Time	Method
Postoperative Delirium (POD)	During the first 5 days after surgery	Delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first 5 days after surgery

Secondary Outcome Measures

Name	Time	Method
Time of delirium onset and duration ,Sedation level	During first 5 days after surgery	1. Time of delirium onset and duration until the end of it.; 2. Sedation level: Assessed using the Richmond Agitation-Sedation Scale (RASS).

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt