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

NCT06756178 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: Elective cardiac surgery
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium - Postoperative

Keywords

cradiac surgery with cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Postoperative Delirium (POD)

  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

  During the first 5 days after surgery

Secondary Outcomes (1)

• Time of delirium onset and duration ,Sedation level

  During first 5 days after surgery

Other Outcomes (1)

• ICU length of stay ,Length of Stay in Hospital After Surgery

  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

Study Arms (3)

Group 1 : propofol group

PLACEBO COMPARATOR

Postoperative Use

Drug: Propofol Group 1

Group 2: Remimazolam Intervention

EXPERIMENTAL

Postoperative Use

Drug: Remimazolam Intervention

Group 3: Dexmedetomidine Intervention

EXPERIMENTAL

Postoperative Use

Drug: Dexmedetomidine Intervention

Interventions

Propofol Group 1 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 1 : propofol group

Remimazolam Intervention 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 2: Remimazolam Intervention

Dexmedetomidine Intervention 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.

Group 3: Dexmedetomidine Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Links

• The effect of perioperative dexmedetomidine on postoperative delirium in adult patients undergoing cardiac surgery with cardiopulmonary bypass
• Clinical Pharmacokinetics and Pharmacodynamics of Dexmedetomidine
• The neuroprotective effect of dexmedetomidine and its mechanism
• Remimazolam: First Approval
• Remimazolam besilate, a benzodiazepine, has been approved for general anesthesia

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Moataz Emad Omar, Assistant lecturer

CONTACT

+2001011990789; moataz.emad90@gmail.com

Ayman Abdel- khalek Mohammed, Lecturer

CONTACT

+2001025675901; aymanglala@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Effect of Remimazolam versus Dexmedetomidine on the incidence of delirium post elective cardiac suregery

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 1, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-11

Locations

EG (1)