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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | General anesthesia will be induced and maintained using continuous infusion of intravenous remimazolam. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from the end of surgery to the postoperative day 5 |
| Delirium subtypes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 days (72 hours) after surgery |
| Severity of postoperative nausea and vomiting (PONV) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiseon Jeong | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38877533 | Derived | 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. |
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The dataset generated during the current study is available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | General anesthesia will be induced and maintained using target-controlled infusion of intravenous propofol. |
|
|
Hypoactive/hyperactive/mixed |
| 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. | 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). | 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) | Up to 1 hour after surgery |
| Intraoperative awareness | Intraoperative awareness will be assessed using Modified Brice questionnaire; binary outcome, not a scored scale. | at postoperative day 0 |
| Undesirable patient movement | Undesirable movement of patient during surgery | 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 | During surgery |
| Intraoperative hypotension | Intraoperative hypotension, quantified as the area under the mean arterial pressure threshold of 65 mm Hg. (Unit: mm Hg·min) | During surgery |
| Quality of early recovery | Quality of Recovery-15 (QoR-15); score range 0-150; higher = better recovery. | 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.) | Up to 30 days after surgery |
| Length of stay in ICU after surgery | days | 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 | 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) | 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. | 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. | 3-months after surgery |
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. |
| 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. | 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) | 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). | During surgery |
| Intraoperative EEG phase-amplitude coupling | Phase-amplitude coupling between EEG frequency bands, derived from intraoperative EEG. | During surgery |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |