Clinical trial NCT06115031: Remimazolam vs. Propofol: Impact on Postoperative Delirium in Neurosurgical Patients
Official title: Effect of Remimazolam Versus Propofol Anesthesia on Postoperative Delirium in Neurosurgical Patients: A Randomised, Controlled, Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Delirium
Keywords: Postoperative delirium
Remimazolam
Total intravenous anesthesia
Neurosurgery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 696
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: Remimazolam, a short-acting benzodiazepine, has recently gained approval for use in the induction and maintanance 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.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesia (ASA) class I - III

Exclusion Criteria:

* Severe respiratory, cardiovascular, or hepatic disease (child-pugh C)
* Dependency on psychiatric drugs or alcohol
* Severe sensory impairments that impede communication
* Preoprative delirium
* Hypersensitivity, allergies, or contraindication to the study drugs.

Primary outcomes:
measure: Postoperative delirium
timeFrame: assessed up to postoperative day 5 or patient discharge, whichever came first
Secondary outcomes:
measure: Onset of postoperative delirium
timeFrame: From the end of surgery until the date of first diagnosis of delirium or discharge, whichever came first, assessed up to postoperative day 5
measure: Delirium subtypes
timeFrame: assessed twice a day up to postoperative day 5 or patient discharge, whichever came first
measure: Severity of postoperative delirium
timeFrame: assessed twice a day up to postoperative day 5 or patient discharge, whichever came first
measure: Duration of postoperative delirium
timeFrame: assessed twice a day up to postoperative day 5 or patient discharge, whichever came first
measure: Subsyndromal delirium
timeFrame: assessed twice a day up to postoperative day 5 or patient discharge, whichever came first
measure: Delirium symptoms
timeFrame: assessed twice a day up to postoperative day 5 or patient discharge, whichever came first
measure: The proportion of valid delirium assessment
timeFrame: assessed twice a day up to postoperative day 5 or patient discharge, whichever came first
measure: Intensive care unit (ICU) admission with endotracheal intubation after surgery
timeFrame: assessed up to postoperative day 5 or patient discharge, whichever came first
measure: Emergence agitation
timeFrame: within 30 min after extubation
measure: Postoperative pain score
timeFrame: assessed once a day up to postoperative day 5 or patient discharge, whichever came first
measure: Opioid consumption
timeFrame: assessed once a day up to postoperative day 5 or patient discharge, whichever came first
measure: Intraoperative awareness
timeFrame: at postoperative day 0
measure: Undesirable patient movement
timeFrame: Intraoperative period
measure: Potential adverse event
timeFrame: From the beginning of anesthesia until 24 hours after surgery
measure: Perioperative serious adverse events
timeFrame: rom date of randomization until 24 hour after surgery
measure: Postoperative complication
timeFrame: Until 30 day after surgery
measure: Length of stay in ICU after surgery
timeFrame: from the day of surgery to the time of patient discharge from ICU, assessed up to 3 months after surgery
measure: Length of stay in hospital after surgery
timeFrame: from the day of surgery to the time of patient discharge, assessed up to 3 months after surgery
measure: Acute kidney injury (AKI) after surgery
timeFrame: within 1 week after surgery
measure: Myocardial injury after non-cardiac surgery (MINS)
timeFrame: within 1-month after surgery
measure: Fall
timeFrame: 3-month after surgery
measure: Postoperative cognitive dysfunction
timeFrame: 3-month after surgery
measure: Functional status
timeFrame: 3-month after surgery
measure: Death
timeFrame: during hospitalization (up to day 30), within 1 year after surgery (3, 6, and 12-month after surgery)
Other outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: within 3 days after surgery
measure: Subgroup analysis of delirium incidence assessed by CAM-ICU or 3D-CAM
timeFrame: assessed up to postoperative day 5 or patient discharge, whichever came first
measure: Electroencephalography (EEG)
timeFrame: Intraoperative period
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jiseon jeong
role: PRINCIPAL_INVESTIGATOR
References: