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

Assiut University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Delirium - Postoperative

Treatments: Drug: Dexmedetomidine Intervention; Drug: Propofol Group 1; Drug: Remimazolam Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06756178

Elective cardiac surgery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 3 patient groups, including a placebo group

Group 1 : propofol group

Placebo Comparator group

Description:

Postoperative Use

Treatment:

Drug: Propofol Group 1

Group 2: Remimazolam Intervention

Experimental group

Description:

Postoperative Use

Treatment:

Drug: Remimazolam Intervention

Group 3: Dexmedetomidine Intervention

Experimental group

Description:

Postoperative Use

Treatment:

Drug: Dexmedetomidine Intervention