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

NCT ID: NCT06756178

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2027-11-01

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.

Conditions

Delirium - Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1 : propofol group

Postoperative Use

Group Type: PLACEBO_COMPARATOR

Propofol Group 1

Intervention Type: DRUG

Postoperative Use:

Bolus: 10-20 mg intravenously as needed for sedation initiation. Continuous infusion: 0.3-0.5 mg/kg/hour to maintain light sedation adjusted based on clinical response.

Group 2: Remimazolam Intervention

Postoperative Use

Group Type: EXPERIMENTAL

Remimazolam Intervention

Intervention Type: DRUG

Postoperative Use:

Initial bolus: 5 mg intravenously upon ICU arrival. Continuous infusion: 0.2-0.3 mg/kg/hour to maintain light sedation with a maximum dose of 0.8 mg/kg/hour.

Rescue sedation with propofol or midazolam will be allowed if patients become agitated or if Remimazolam is ineffective in maintaining target sedation.

Group 3: Dexmedetomidine Intervention

Postoperative Use

Group Type: EXPERIMENTAL

Dexmedetomidine Intervention

Intervention Type: DRUG

Postoperative Use:

Loading dose: 0.5-1 μg/kg over 10-20 minutes after ICU arrival. Continuous infusion: 0.2-0.7 μg/kg/hour for sedation maintenance, adjusted as needed to maintain light sedation.

Rescue sedation with propofol or midazolam will be administered if Dexmedetomidine fails to maintain adequate sedation or if patients become agitated.

Interventions

Propofol Group 1

Postoperative Use:

Bolus: 10-20 mg intravenously as needed for sedation initiation. Continuous infusion: 0.3-0.5 mg/kg/hour to maintain light sedation adjusted based on clinical response.

Intervention Type: DRUG

Remimazolam Intervention

Postoperative Use:

Initial bolus: 5 mg intravenously upon ICU arrival. Continuous infusion: 0.2-0.3 mg/kg/hour to maintain light sedation with a maximum dose of 0.8 mg/kg/hour.

Rescue sedation with propofol or midazolam will be allowed if patients become agitated or if Remimazolam is ineffective in maintaining target sedation.

Intervention Type: DRUG

Dexmedetomidine Intervention

Postoperative Use:

Loading dose: 0.5-1 μg/kg over 10-20 minutes after ICU arrival. Continuous infusion: 0.2-0.7 μg/kg/hour for sedation maintenance, adjusted as needed to maintain light sedation.

Rescue sedation with propofol or midazolam will be administered if Dexmedetomidine fails to maintain adequate sedation or if patients become agitated.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Moataz Emad Eldin Omar Mohamed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Central Contacts

Moataz Emad Omar, Assistant lecturer

Role: CONTACT

moataz.emad90@gmail.com

+2001011990789

Ayman Abdel- khalek Mohammed, Lecturer

Role: CONTACT

aymanglala@aun.edu.eg

+2001025675901

Related Links

https://link.springer.com/article/10.1186/s12871-024-02715-2

The effect of perioperative dexmedetomidine on postoperative delirium in adult patients undergoing cardiac surgery with cardiopulmonary bypass

https://link.springer.com/article/10.1007/s40262-017-0507-7

Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine

https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.965661/full

The neuroprotective effect of dexmedetomidine and its mechanism

https://link.springer.com/article/10.1007/s40265-020-01299-8

Remimazolam: First Approval

https://link.springer.com/article/10.1007/s00540-020-02755-1

Remimazolam besilate, a benzodiazepine, has been approved for general anesthesia

Other Identifiers

Elective cardiac surgery

Identifier Type: -

Identifier Source: org_study_id