AzTrials
AzTrials

Postoperative DeliriumNCT06115031

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

A study testing Remimazolam and Propofol in people with Postoperative Delirium, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Postoperative Delirium
What is being tested?
Remimazolam and Propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
696 participants
Where
1 siteSouth Korea
Study dates
13 Nov 2023to 21 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, Seoul, 06351

Other trials in South Korea

About this study

Official title: Effect of Remimazolam Versus Propofol Anesthesia on Postoperative Delirium in Neurosurgical Patients: A Randomised, Controlled, Noninferiority Trial

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.

Read the detailed description

Remimazolam, a short-acting benzodiazepine, has recently gained approval for use in the induction and maintenance of general anesthesia. In American Society of Anesthesiologists (ASA) physical status class I and II patients undergoing general anesthesia, the remimazolam-based TIVA has shown comparable efficacy to propofol-based TIVA while demonstrating a superior safety profile. Remimazolam has exhibited a lower incidence of hypotension, reduced vasopressor requirements, and fewer instances of bradycardia compared to the propofol-based TIVA.

The use of benzodiazepine has been associated with an increased risk of postoperative delirium, but there is currently no randomized controlled trial investigating the relationship between remimazolam, a new short-acting benzodiazepine, and postoperative delirium. Therefore, the investigators designed this prospective, randomized, double-blinded, active comparator-controlled, non-inferiority trial to investigate the incidence of postoperative delirium after remimazolam-based TIVA compared with propofol-based TIVA in neurosurgery patients.

Being tested
Remimazolam, Propofol
Keywords
Postoperative delirium, Remimazolam, Total intravenous anesthesia, Neurosurgery
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemimazolamDrug

    Also called byfavo inj

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

  • PropofolDrug

    Also called Fresofol

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

Study groups in NCT06115031
Study groupRoleWhat they receive
RemimazolamExperimentalGeneral 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.
Receives: Drug: Remimazolam
PropofolActive comparatorGeneral 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.
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (16)

  1. Duration of postoperative delirium

    Duration is quantified as the cumulative number of positive CAM-ICU or 3D-CAM assessments (protocol secondary outcome: number of positive delirium assessment) collected twice daily.

    Measured: from the end of surgery to the postoperative day 5

  2. Delirium subtypes

    Hypoactive/hyperactive/mixed

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

  3. Severity of postoperative delirium

    Severity of postoperative delirium will be assessed twice a day using DRS-R-98 (delirium rating scale-revised-98); total score range 0-46; higher scores = more severe delirium.

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

  4. Emergence agitation

    Incidence of emergence agitation, defined as Richmond Agitation-Sedation Scale (RASS) ≥+1 within 30 minutes after extubation. RASS ranges from -5 to +4; higher scores indicate greater agitation. The outcome is binary (emergence agitation present vs absent).

    Measured: within 30 min after extubation

  5. delayed extubation

    Percentage of the patients who were not extubated in the OR and transferred to the ICU, delayed extubation (> 1 h after surgery completion)

    Measured: Up to 1 hour after surgery

  6. Intraoperative awareness

    Intraoperative awareness will be assessed using Modified Brice questionnaire; binary outcome, not a scored scale.

    Measured: at postoperative day 0

  7. Undesirable patient movement

    Undesirable movement of patient during surgery

    Measured: During surgery

  8. Intraoperative adverse events

    bradycardia with the use of chronotropic agent, laryngeal spasm, bronchospasm, allergic reaction, arrhythmia, cardiac events (myocardial infarction, vasospasm, or cardiac arrest), or massive bleeding

    Measured: During surgery

  9. Intraoperative hypotension

    Intraoperative hypotension, quantified as the area under the mean arterial pressure threshold of 65 mm Hg. (Unit: mm Hg·min)

    Measured: During surgery

  10. Quality of early recovery

    Quality of Recovery-15 (QoR-15); score range 0-150; higher = better recovery.

    Measured: postoperative day 1

  11. Postoperative complication

    assessed by Clavien-Dindo classification Data are presented as the proportion of patients with 1 or more events (edema, vasospasm, rebleeding, seizures, and/or ischemia, etc.)

    Measured: Up to 30 days after surgery

  12. Length of stay in ICU after surgery

    days

    Measured: from the day of surgery to the time of patient discharge from ICU, assessed up to 3 months after surgery

  13. Length of stay in hospital after surgery

    days

    Measured: from the day of surgery to the time of patient discharge, assessed up to 3 months after surgery

  14. Fall

    the incidence of postoperative falls and associated injury (presence of fracture)

    Measured: 3-months after surgery

  15. Postoperative cognitive dysfunction

    Changes in cognition assessed by Montreal Cognitive Assessment (MoCA) at baseline and postoperative day 7 (or discharge, whichever comes first); range 0-30; higher = better cognition. And by telephone-MoCA (T-MoCA) at 3 months;range 0-22; higher = better cognition.

    Measured: postoperative day 7, 3-months after surgery

  16. Functional status

    assessed using Barthel activity of daily living (ADL) index

    ; score range 0-20; higher = greater independence.

    Measured: 3-months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start13 Nov 2023
  3. Primary completion24 Nov 2025
  4. Study completion21 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
696 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115031
Sponsor's protocol ID
SMC 2023-08-135
Status last verified
Jun 2026
First submitted
24 Oct 2023
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The dataset generated during the current study is available from the corresponding author upon reasonable request.

Publications

  • Kim J, Lee S, Bang YJ, Lee S, Ahn HJ, Park MH, Gwak MS, Oh EJ, Lee JJ, Kwon JH, Jeong JS. Effect of remimazolam versus propofol anaesthesia on postoperative delirium in neurovascular surgery: a randomised noninferiority trial. Br J Anaesth. 2026 Oct 29:S0007-0912(26)00742-7. doi: 10.1016/j.bja.2026.09.021. Online ahead of print.

    PubMed 42957499

  • 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.

    PubMed 38877533

Questions about this trial

What is this clinical trial studying?

A study testing Remimazolam and Propofol in people with Postoperative Delirium, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative delirium (time frame: assessed up to postoperative day 5 or patient discharge, whichever came first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06115031, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in