Remimazolam vs. Propofol: Impact on Postoperative Delirium in Neurosurgical Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Remimazolam
General anesthesia will be induced and maintained using continuous infusion of intravenous remimazolam.
Other Names:
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| Active Comparator: 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. |
Drug: Propofol
General anesthesia will be induced and maintained using target-controlled infusion of intravenous propofol.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Postoperative delirium [assessed up to postoperative day 7 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
- 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 7]
The time of initial diagnosis of postoperative delirium
- Delirium subtypes [assessed twice a day up to postoperative day 7 or patient discharge, whichever came first]
Hypoactive/hyperactive/mixed
- Severity of postoperative delirium [assessed twice a day up to postoperative day 7 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)
- Duration of postoperative delirium [assessed twice a day up to postoperative day 7 or patient discharge, whichever came first]
Duration of postoperative delirium will be assessed twice a day
- Subsyndromal delirium [assessed twice a day up to postoperative day 7 or patient discharge, whichever came first]
Presence of any CAM features with absence of full syndromal delirium
- Delirium symptoms [assessed twice a day up to postoperative day 7 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 7 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.
- Intensive care unit (ICU) admission with endotracheal intubation after surgery [assessed up to postoperative day 7 or patient discharge, whichever came first]
Percentage of the patients who were not extubated in the OR and transferred to the ICU
- Emergence agitation [within 30 min after extubation]
defined as Richmond Agitation-Sedation Scale ≥+1
- Postoperative pain score [assessed once a day up to postoperative day 7 or patient discharge, whichever came first]
Pain level will be assessed using numeric rating score (NRS)
- Opioid consumption [assessed once a day up to postoperative day 7 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.
- Undesirable patient movement [Intraoperative period]
Undesirable movement of patient during surgery
- 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
- 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.
- 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
- Fall [3-month after surgery]
postoperative fall-down and associated injury
- Postoperative cognitive dysfunction [3-month after surgery]
assessed by T-MOCA (Montreal Cognitive Assessment) using telephone interview
- Functional status [3-month after surgery]
assessed using bartel activity of daily living (ADL) index
- Death [In hospital, 3, 6, and 12-month after surgery]
All-cause mortality
Other Outcome Measures
- Postoperative nausea and vomiting (PONV) [within 3 days after surgery]
PONV substudy are 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: Jiseon jeong, Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMC 2023-08-135