Clinical trial NCT06756178: Effect of Remimazolam Versus Dexmedetomidine on the Incidence of Delirium After Elective Cardiac Surgery with Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial
Official title: Effect of Remimazolam Versus Dexmedetomidine on the Incidence of Delirium After Elective Cardiac Surgery with Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Delirium - Postoperative
Keywords: cradiac surgery with cardiopulmonary bypass
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effect of Remimazolam versus Dexmedetomidine on the incidence of delirium post elective cardiac suregery
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Delirium (POD)
timeFrame: During the first 5 days after surgery
Secondary outcomes:
measure: Time of delirium onset and duration ,Sedation level
timeFrame: During first 5 days after surgery
Other outcomes:
measure: ICU length of stay ,Length of Stay in Hospital After Surgery
timeFrame: From end of surgery until discharge from Intensive Care Unit or 30 days after surgery. From end of surgery until discharge from hospital or 30 days after surgery
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References: