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

Last updated: December 25, 2024
Sponsor: Assiut University
Overall Status: Active - Not Recruiting

Phase

1

Condition

Dementia

Treatment

Propofol Group 1

Remimazolam Intervention

Dexmedetomidine Intervention

Clinical Study ID

NCT06756178
Elective cardiac surgery
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years.

  • Scheduled for cardiac surgery (CABG and/or valve replacement).

  • Elective surgery

Exclusion

Exclusion Criteria:

  • Patients with known allergies to Remimazolam or Dexmedetomidine

  • Refusal to participate.

  • History of psychiatric or neurological conditions (schizophrenia, epilepsy, severedementia, etc.).

  • Preoperative inability to communicate (severe visual/auditory dysfunction, languagebarriers).

  • 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

Total Participants: 111
Treatment Group(s): 3
Primary Treatment: Propofol Group 1
Phase: 1
Study Start date:
January 10, 2025
Estimated Completion Date:
November 01, 2027

Study 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.

Connect with a study center

  • Assiut University

    Assiut,
    Egypt

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.