Effect of Remimazolam vs Conventinal Anesthesia on Postoperative Delirium in Patients with Cardiac Surgery

JRCT ID: jRCT1051210195

Registered date:17/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: heart disease
• Date of first enrollment: 17/03/2022
• Target sample size: 250
• Study type: Interventional

Intervention(s)

Arm Remimazolam : use Remimazolam as a general anesthesia maintenance drug
Arm Placebo : use Propofol or Desflurane as a general anesthesia maintenance drug

Outcome(s)

• Primary Outcome: Incidence of postoperative delirium up to 5 days after surgery using ICDSC score

Secondary Outcome

(1) Total amount of circulatory agonist, blood and water balance, usage of IABP/PCPS during the operation
(2) Total amount of fentanyl and remifentanil
(3) Total amount of target mean arterial blood pressure (50~100mmHg) deviation time
(4) rSO2
(5) Perioperative complications (acute kidey injury, stroke/cerebral hemorrhage), myocardial infarction, tracheostomy
(6) Perioperative death
(7) Perioperative ventilation time, intensive care unit admission period, hospitalization period
(8) Anesthesia time, surgery time, cardiopulmonary bypass time, aortic clump time

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with heart disease who need cardiac surgery and have been requested for general anesthesia by cardiovascular surgeons
(2) Scheduled procedure is valve replacement/plasty, coronary artery bypass grafting, ventricular assist device insertion/replacement, cardiac tumor resection, or combination surgery.
(3) The patients age at the time of obtaining consent is 20 years or older.
(4) A written consent of this study has been obtained from the individual.

Exclude criteria

(1) Patients with cerebrovascular disease within 3 months
(2) Patients with drug abuse.
(3) Patients undergoing surgery including aortic surgery as combined surgery
(4) Patients who require hypothermic circulatory arrest for scheduled procedure
(5) Patients with surgery due to congenital heart disease
(6) Patients who have contraindication for any anesthetics
(7) Patients who are deemed inappropriate as research subjects by the investigators for other reasons

Related Information

• Primary Sponsor: Iguchi Naoya