NCT06180876

Brief Summary

Remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. It can be used for general anesthesia. However, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. Thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

June 28, 2022

Last Update Submit

February 20, 2026

Conditions

General Anesthetic Drug Adverse Reaction

Keywords

general anesthesiaelderly patientsremimazolampropofol

Outcome Measures

Primary Outcomes (1)

  • incidence of delirium by 3 days after surgery

    from end of surgery to 3 days after surgery, in a total of 3 days

Secondary Outcomes (6)

  • incidence of delirium by 30 minutes after extubation

    from extubation of tracheal tube to 30 minutes after extubation, in a total of 30 minutes

  • incidence of delirium by 1 day after surgery

    from end of surgery to 1 day after surgery, in a total of 1 day

  • time to awake

    from end of surgery to response to verbal command, in an average of 10 minutes

  • incidence of hypotension during surgery

    from start of anesthesia induction to extubation, in an average of 2 hours

  • incidence of hypertension during surgery

    from start of anesthesia induction to extubation, in an average of 2 hours

  • +1 more secondary outcomes

Study Arms (2)

remimazolam

EXPERIMENTAL

remimazolam continuous infusion is used for general anesthesia; dosage:0.7-1.5mg/kg/h; duration: from start of anesthesia induction to end of surgery

Drug: remimazolam

propofol

ACTIVE COMPARATOR

propofol continuous infusion is used for general anesthesia; dosage:4-8mg/kg/h; duration: from start of anesthesia induction to end of surgery

Drug: propofol

Interventions

remimazolamDRUG

continuous infusion

remimazolam
propofolDRUG

continuous infusion

propofol

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥60 years
  • patients scheduled for elective surgery under general anesthesia

You may not qualify if:

  • American Society of Anesthesiologists status ≥Ⅳ
  • history of neurologic or psychiatric diseases
  • difficulty in communication
  • abuse of drug or alcohol
  • suspected allergy to propofol or benzodiazepines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital, Fourth military medical university

Xi'an, Shaanxi, 710032, China

Location

Related Publications (5)

  • Tang F, Yi JM, Gong HY, Lu ZY, Chen J, Fang B, Chen C, Liu ZY. Remimazolam benzenesulfonate anesthesia effectiveness in cardiac surgery patients under general anesthesia. World J Clin Cases. 2021 Dec 6;9(34):10595-10603. doi: 10.12998/wjcc.v9.i34.10595.

    PMID: 35004991BACKGROUND

  • Liu T, Lai T, Chen J, Lu Y, He F, Chen Y, Xie Y. Effect of remimazolam induction on hemodynamics in patients undergoing valve replacement surgery: A randomized, double-blind, controlled trial. Pharmacol Res Perspect. 2021 Oct;9(5):e00851. doi: 10.1002/prp2.851.

    PMID: 34390228BACKGROUND

  • Kilpatrick GJ. Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent. Front Pharmacol. 2021 Jul 20;12:690875. doi: 10.3389/fphar.2021.690875. eCollection 2021.

    PMID: 34354587BACKGROUND

  • Doi M, Morita K, Takeda J, Sakamoto A, Yamakage M, Suzuki T. Efficacy and safety of remimazolam versus propofol for general anesthesia: a multicenter, single-blind, randomized, parallel-group, phase IIb/III trial. J Anesth. 2020 Aug;34(4):543-553. doi: 10.1007/s00540-020-02788-6. Epub 2020 May 16.

    PMID: 32417976BACKGROUND

  • Oka S, Satomi H, Sekino R, Taguchi K, Kajiwara M, Oi Y, Kobayashi R. Sedation outcomes for remimazolam, a new benzodiazepine. J Oral Sci. 2021 Jun 29;63(3):209-211. doi: 10.2334/josnusd.21-0051. Epub 2021 Jun 7.

    PMID: 34092775BACKGROUND

MeSH Terms

Interventions

remimazolamPropofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 28, 2022

First Posted

December 26, 2023

Study Start

July 25, 2022

Primary Completion

January 25, 2024

Study Completion

January 30, 2024

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

CN(1)