Postoperative Delirium
Conditions
Keywords
Postoperative delirium, Remimazolam, Total intravenous anesthesia, Neurosurgery
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.
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.
Interventions
DRUGRemimazolam
General anesthesia will be induced and maintained using continuous infusion of intravenous remimazolam.
DRUGPropofol
General anesthesia will be induced and maintained using target-controlled infusion of intravenous propofol.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status 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 * Preoperative delirium * Hypersensitivity, allergies, or contraindication to the study drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | assessed up to postoperative day 5 or patient discharge, whichever came first | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of postoperative delirium | from the end of surgery to the postoperative day 5 | 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. |
| Delirium subtypes | assessed twice a day up to postoperative day 5 or patient discharge, whichever came first | Hypoactive/hyperactive/mixed |
| Severity of postoperative delirium | assessed twice a day up to postoperative day 5 or patient discharge, whichever came first | 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. |
| Emergence agitation | within 30 min after extubation | 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). |
| delayed extubation | Up to 1 hour after surgery | Percentage of the patients who were not extubated in the OR and transferred to the ICU, delayed extubation (\> 1 h after surgery completion) |
| Intraoperative awareness | at postoperative day 0 | Intraoperative awareness will be assessed using Modified Brice questionnaire; binary outcome, not a scored scale. |
| Undesirable patient movement | During surgery | Undesirable movement of patient during surgery |
| Intraoperative adverse events | During surgery | bradycardia with the use of chronotropic agent, laryngeal spasm, bronchospasm, allergic reaction, arrhythmia, cardiac events (myocardial infarction, vasospasm, or cardiac arrest), or massive bleeding |
| Intraoperative hypotension | During surgery | Intraoperative hypotension, quantified as the area under the mean arterial pressure threshold of 65 mm Hg. (Unit: mm Hg·min) |
| Quality of early recovery | postoperative day 1 | Quality of Recovery-15 (QoR-15); score range 0-150; higher = better recovery. |
| Postoperative complication | Up to 30 days after surgery | 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.) |
| Length of stay in ICU after surgery | from the day of surgery to the time of patient discharge from ICU, assessed up to 3 months after surgery | days |
| Length of stay in hospital after surgery | from the day of surgery to the time of patient discharge, assessed up to 3 months after surgery | days |
| Fall | 3-months after surgery | the incidence of postoperative falls and associated injury (presence of fracture) |
| Postoperative cognitive dysfunction | postoperative day 7, 3-months after surgery | 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. |
| Functional status | 3-months after surgery | assessed using Barthel activity of daily living (ADL) index ; score range 0-20; higher = greater independence. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJiseon Jeong
Samsung Medical Center
Outcome results
None listed