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Remimazolam vs. Propofol: Impact on Postoperative Delirium in Neurosurgical Patients

Recruiting
19 years of age
Both
Phase N/A

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Overview

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.

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.

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.

Study details

Postoperative Delirium

NCT06115031

Samsung Medical Center

2 May 2024

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