Effect of Remimazolam and Propofol on Postoperative Delirium

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-100
SponsorInje University

About this trial

Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

elderly patients undergoing hip or knee arthroplasty under general anesthesia.

body mass index >30 kg/m2

Disqualifiers

moderate to severe liver dysfunction

moderate to severe renal dysfunction

unable to extubate in the operation room after operation

benzodiazepine dependence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam (Byfavo)

    Drug

    Remimazolam is continuously infused based on bispectral index (within 40-60).

  • Propofol

    Drug

    Propofol is continuously infused based on bispectral index (within 40-60).

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Remimazolam groupExperimental treatment 1 intervention
Group B: Propofol groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of delirium 3 days after the end of operation

delirium is evaluated preoperatively and 3 days after surgery using Mini-Mental State Examination

Time frame
Upto 3 days after surgery

Secondary outcomes

1

quality of recovery (QoR-15) 3 days after the end of the operation

QoR-15 survey is performed preoperatively and 3 days after surgery.

Time frame
Upto 3 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.