Remimazolam vs. Propofol: Impact on Postoperative Delirium in Neurosurgical Patients

NCT06115031 | Completed DMC

• 1 other identifier: SMC 2023-08-135
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator aimed to evaluate the incidence of postoperative delirium after remimazolam-based total intravenous anesthesia (TIVA) compared to the propofol-based TIVA in patients undergoing neurosurgery.

Conditions

Postoperative Delirium

Keywords

Postoperative delirium; Remimazolam; Total intravenous anesthesia; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium

  The occurrence of postoperative delirium, defined as at least one positive assessment during the postoperative period. Delirium will be assessed twice a day using confusion assessment method for the intensive care unit (CAM-ICU) and 3-minute diagnostic assessment for CAM-defined delirium (3D-CAM). These are binary diagnostic instruments (delirium present vs absent), not scored scales.

  assessed up to postoperative day 5 or patient discharge, whichever came first

Secondary Outcomes (16)

• Duration of postoperative delirium

  from the end of surgery to the postoperative day 5

• Delirium subtypes

  assessed twice a day up to postoperative day 5 or patient discharge, whichever came first

• Severity of postoperative delirium

  assessed twice a day up to postoperative day 5 or patient discharge, whichever came first

• Emergence agitation

  within 30 min after extubation

• delayed extubation

  Up to 1 hour after surgery

Other Outcomes (6)

• Incidence of postoperative nausea and vomiting (PONV)

  Up to 3 days (72 hours) after surgery

• Severity of postoperative nausea and vomiting (PONV)

  Up to 3 days (72 hours) after surgery

• Rescue anti-emetic administration

  Up to 3 days (72 hours) after surgery

Study Arms (2)

Remimazolam

EXPERIMENTAL

General anesthesia using continuous infusion of intravenous remimazolam and remifentanil. Remimazolam will be used for maintenance of general anesthesia and adjusted between 0.6-2mg/kg/hr until the end of surgery.

Drug: Remimazolam

Propofol

ACTIVE COMPARATOR

General anesthesia using target-controlled infusion of intravenous propofol and remifentanil. Propofol will be adjusted maintaining the BIS between 40-60 until the end of surgery.

Drug: Propofol

Interventions

Remimazolam DRUG

General anesthesia will be induced and maintained using continuous infusion of intravenous remimazolam.

Also known as: byfavo inj

Remimazolam

Propofol DRUG

General anesthesia will be induced and maintained using target-controlled infusion of intravenous propofol.

Also known as: Fresofol

Propofol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status class I - III

You may not qualify if:

• Severe respiratory, cardiovascular, or hepatic disease (Child-Pugh C)
• Dependency on psychiatric drugs or alcohol
• Severe sensory impairments that impede communication
• Preoperative delirium
• Hypersensitivity, allergies, or contraindication to the study drugs.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

Related Publications (1)

• Kim J, Lee S, Park B, Sim WS, Ahn HJ, Park MH, Jeong JS. Effect of remimazolam versus propofol anesthesia on postoperative delirium in neurovascular surgery: study protocol for a randomized controlled, non-inferiority trial. Perioper Med (Lond). 2024 Jun 14;13(1):56. doi: 10.1186/s13741-024-00415-6.

  PMID: 38877533 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

remimazolam; Propofol

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jiseon Jeong

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 2, 2023
• Study Start: November 13, 2023
• Primary Completion: November 24, 2025
• Study Completion: February 21, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)