Remimazolam vs. Propofol: Impact on Postoperative Delirium in Neurosurgical Patients
- Conditions
- Postoperative Delirium
- Interventions
- Registration Number
- NCT06115031
- Lead Sponsor
- Samsung Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 696
- American society of anesthesia (ASA) class I - III
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remimazolam Remimazolam 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 Propofol 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.
- Primary Outcome Measures
Name Time Method Postoperative delirium assessed up to postoperative day 5 or patient discharge, whichever came first 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).
- Secondary Outcome Measures
Name Time Method Onset 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 The time of initial diagnosis of postoperative delirium
Delirium symptoms assessed twice a day up to postoperative day 5 or patient discharge, whichever came first Subsyndromal delirium plus syndromal delirium
The proportion of valid delirium assessment assessed twice a day up to postoperative day 5 or patient discharge, whichever came first The percentage of valid delirium assessments (per patient) that did not involve coma or stupor out of a total of 14 delirium assessments.
Delirium subtypes assessed twice a day up to postoperative day 5 or patient discharge, whichever came first Hypoactive/hyperactive/mixed
Undesirable patient movement Intraoperative period Undesirable movement of patient during surgery
Perioperative serious adverse events rom date of randomization until 24 hour after surgery 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.
Intensive care unit (ICU) admission with endotracheal intubation after surgery assessed up to postoperative day 5 or patient discharge, whichever came first Percentage of the patients who were not extubated in the OR and transferred to the ICU
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)
Emergence agitation within 30 min after extubation defined as Richmond Agitation-Sedation Scale ≥+1
Subsyndromal delirium assessed twice a day up to postoperative day 5 or patient discharge, whichever came first Presence of any CAM features with absence of full syndromal delirium
Postoperative pain score assessed once a day up to postoperative day 5 or patient discharge, whichever came first Pain level will be assessed using numeric rating score (NRS)
Functional status 3-month after surgery assessed using bartel activity of daily living (ADL) index
Death during hospitalization (up to day 30), within 1 year after surgery (3, 6, and 12-month after surgery) All-cause mortality
Duration of postoperative delirium assessed twice a day up to postoperative day 5 or patient discharge, whichever came first Duration of postoperative delirium will be assessed twice a day
Opioid consumption assessed once a day up to postoperative day 5 or patient discharge, whichever came first The amount of opioid consumption will be coverted to parenteral morphine equivalent dose (MED).
Intraoperative awareness at postoperative day 0 Intraoperative awareness will be assess using Modified brice questionnaire.
Potential adverse event From the beginning of anesthesia until 24 hours after surgery hypotension, hypertension, bradycardia, tachycardia, desaturation, teeth injury, laryngeal spasm, allergic reaction, other arrhtymia, cardiac events, pruritis, nausea, vomiting etc
Postoperative complication Until 30 day 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
Acute kidney injury (AKI) after surgery within 1 week after surgery AKI assessed by KDIGO criteria
Postoperative cognitive dysfunction 3-month after surgery assessed by T-MOCA (Montreal Cognitive Assessment) using telephone interview
Myocardial injury after non-cardiac surgery (MINS) within 1-month after surgery MINS assessed by high-sensitive TnT
Fall 3-month after surgery the incidence of postoperative fall-down and associated injury (presence of fracture)
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of