Postoperative Delirium Clinical Trial
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 anestheisa (TIVA) compared to the propofol-based TIVA in patients undergoing neurosurgery.
Status | Recruiting |
Enrollment | 696 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Postoperative nausea and vomiting (PONV) | PONV substudy are pre-planned non-inferioirty substudy for this main trial. In addition to the data collected as part of the main trial, patients enrolled into the PONV substudy were assessed the frequency and severity of nausea and vomiting, and frequency of antiemetic administration using validated questinnaire. | within 3 days after surgery | |
Other | Subgroup analysis of delirium incidence assessed by CAM-ICU or 3D-CAM | Subgroup analysis according to the surgery type, patients' age, and preoperative cognitive function and frailty | assessed up to postoperative day 5 or patient discharge, whichever came first | |
Other | Electroencephalography (EEG) | EEG substudy are pre-planned. The association between the development of postoperative delirium, pre&postoperative cognitive function, severe postoperaitve pain and spectral power of alpha, beta, delta, and theta band. Phase-amplitude coupling of each bands | Intraoperative period | |
Primary | Postoperative delirium | The occurence of postoperative 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). | assessed up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Onset of postoperative delirium | The time of initial diagnosis of postoperative delirium | From the end of surgery until the date of first diagnosis of delirium or discharge, whichever came first, assessed up to postoperative day 5 | |
Secondary | Delirium subtypes | Hypoactive/hyperactive/mixed | assessed twice a day up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Severity of postoperative delirium | Severity of postoperative delirium will be assessed twice a day using DRS-R-98 (delirium rating scale-revised-98) | assessed twice a day up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Duration of postoperative delirium | Duration of postoperative delirium will be assessed twice a day | assessed twice a day up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Subsyndromal delirium | Presence of any CAM features with absence of full syndromal delirium | assessed twice a day up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Delirium symptoms | Subsyndromal delirium plus syndromal delirium | assessed twice a day up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | The proportion of valid delirium assessment | The percentage of valid delirium assessments (per patient) that did not involve coma or stupor out of a total of 14 delirium assessments. | assessed twice a day up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Intensive care unit (ICU) admission with endotracheal intubation after surgery | Percentage of the patients who were not extubated in the OR and transferred to the ICU | assessed up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Emergence agitation | defined as Richmond Agitation-Sedation Scale =+1 | within 30 min after extubation | |
Secondary | Postoperative pain score | Pain level will be assessed using numeric rating score (NRS) | assessed once a day up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Opioid consumption | The amount of opioid consumption will be coverted to parenteral morphine equivalent dose (MED). | assessed once a day up to postoperative day 5 or patient discharge, whichever came first | |
Secondary | Intraoperative awareness | Intraoperative awareness will be assess using Modified brice questionnaire. | at postoperative day 0 | |
Secondary | Undesirable patient movement | Undesirable movement of patient during surgery | Intraoperative period | |
Secondary | Potential adverse event | hypotension, hypertension, bradycardia, tachycardia, desaturation, teeth injury, laryngeal spasm, allergic reaction, other arrhtymia, cardiac events, pruritis, nausea, vomiting etc | From the beginning of anesthesia until 24 hours after surgery | |
Secondary | Perioperative serious adverse events | Serious adverse events are adverse events that result in hospitalization or prolong hospitalization, cause persistent or significant disability, are life-threatening, or result in death. | rom date of randomization until 24 hour after surgery | |
Secondary | 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..) | Until 30 day after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Acute kidney injury (AKI) after surgery | AKI assessed by KDIGO criteria | within 1 week after surgery | |
Secondary | Myocardial injury after non-cardiac surgery (MINS) | MINS assessed by high-sensitive TnT | within 1-month after surgery | |
Secondary | Fall | the incidence of postoperative fall-down and associated injury (presence of fracture) | 3-month after surgery | |
Secondary | Postoperative cognitive dysfunction | assessed by T-MOCA (Montreal Cognitive Assessment) using telephone interview | 3-month after surgery | |
Secondary | Functional status | assessed using bartel activity of daily living (ADL) index | 3-month after surgery | |
Secondary | Death | All-cause mortality | during hospitalization (up to day 30), within 1 year after surgery (3, 6, and 12-month after surgery) |
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