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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

696 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

General anesthesia will be induced and maintained using continuous infusion of intravenous remimazolam.

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

General anesthesia will be induced and maintained using target-controlled infusion of intravenous propofol.

Interventions

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Remimazolam

General anesthesia will be induced and maintained using continuous infusion of intravenous remimazolam.

Intervention Type DRUG

Propofol

General anesthesia will be induced and maintained using target-controlled infusion of intravenous propofol.

Intervention Type DRUG

Other Intervention Names

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byfavo inj Fresofol

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No