An interventional study of Remimazolam and Propofol in Postoperative Delirium, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Prevention
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.
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.
763 studies on the registry are indexed under Emergence Delirium; 241 are open to participants now.
This study's enrollment of 696 is above the median of 120 across 475 interventional studies indexed under Emergence Delirium.
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Exclusion Criteria:
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
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
General anesthesia will be induced and maintained using continuous infusion of intravenous remimazolam.
Also known as: byfavo inj
General anesthesia will be induced and maintained using target-controlled infusion of intravenous propofol.
Also known as: Fresofol
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.
Time frame: assessed up to postoperative day 5 or patient discharge, whichever came first
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.
Time frame: from the end of surgery to the postoperative day 5
Delirium subtypes
Hypoactive/hyperactive/mixed
Time frame: assessed twice a day up to postoperative day 5 or patient discharge, whichever came first
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.
Time frame: assessed twice a day up to postoperative day 5 or patient discharge, whichever came first
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).
Time frame: within 30 min after extubation
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)
Time frame: Up to 1 hour after surgery
Intraoperative awareness
Intraoperative awareness will be assessed using Modified Brice questionnaire; binary outcome, not a scored scale.
Time frame: at postoperative day 0
Undesirable patient movement
Undesirable movement of patient during surgery
Time frame: During surgery
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
Time frame: During surgery
Intraoperative hypotension
Intraoperative hypotension, quantified as the area under the mean arterial pressure threshold of 65 mm Hg. (Unit: mm Hg·min)
Time frame: During surgery
Quality of early recovery
Quality of Recovery-15 (QoR-15); score range 0-150; higher = better recovery.
Time frame: postoperative day 1
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.)
Time frame: Up to 30 days after surgery
Length of stay in ICU after surgery
days
Time frame: from the day of surgery to the time of patient discharge from ICU, assessed up to 3 months after surgery
Length of stay in hospital after surgery
days
Time frame: from the day of surgery to the time of patient discharge, assessed up to 3 months after surgery
Fall
the incidence of postoperative falls and associated injury (presence of fracture)
Time frame: 3-months after surgery
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.
Time frame: postoperative day 7, 3-months after surgery
Functional status
assessed using Barthel activity of daily living (ADL) index ; score range 0-20; higher = greater independence.
Time frame: 3-months after surgery
Incidence of postoperative nausea and vomiting (PONV)
PONV sub-study is a pre-planned non-inferiority sub-study for this main trial. Number (percentage) of participants with nausea and/or vomiting, assessed in participants enrolled in the PONV sub-study.
Time frame: Up to 3 days (72 hours) after surgery
Severity of postoperative nausea and vomiting (PONV)
Severity of postoperative nausea and vomiting, assessed using the PONV Intensity Scale in participants enrolled in the PONV sub-study. Higher scores indicate more severe PONV.
Time frame: Up to 3 days (72 hours) after surgery
Rescue anti-emetic administration
Number (percentage) of participants who received rescue anti-emetic medication in the PONV sub-study.
Time frame: Up to 3 days (72 hours) after surgery
Subgroup analysis of delirium incidence assessed by CAM-ICU or 3D-CAM
Subgroup analysis (age, sex, surgery type, preoperative cognitive impairment, ASA physical status, duration of anesthesia, alcohol abuse, or chronic benzodiazepine use)
Time frame: assessed up to postoperative day 5 or patient discharge, whichever came first
Intraoperative EEG spectral power
Relative spectral power in the alpha, beta, delta, and theta frequency bands, derived from intraoperative electroencephalography (EEG).
Time frame: During surgery
Intraoperative EEG phase-amplitude coupling
Phase-amplitude coupling between EEG frequency bands, derived from intraoperative EEG.
Time frame: During surgery
Plan to share: No — The dataset generated during the current study is available from the corresponding author upon reasonable request.
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