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

Not Applicable

Recruiting

• Conditions: heart disease; Valvular disease, Ischemic heart disease, Hypocardiac function; D006331

• Registration Number: JPRN-jRCT1051210195
• Lead Sponsor: Iguchi Naoya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium up to 5 days after surgery using ICDSC score

Secondary Outcome Measures

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