NCT05774366

Brief Summary

The goal of this prospective, randomized study is to compare recovery characteristics between remimazolam anesthesia with flumazenil and desflurane anesthesia in patients undergoing closed reduction of nasal bone fracture. The main question this study aims to answer is:

  • Is there statistically significant difference in time from discontinuation of the anesthetic agent up to patient's response to verbal command between these two groups? Participants will receive either remimazolam or desflurane for the maintenance of general anesthesia. When the surgery ends, the anesthetic agent will be stopped. For Remimazolam group, flumazenil will be administered as an antagonist of remimazolam.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

March 7, 2023

Last Update Submit

September 6, 2023

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Time to follow verbal command

    Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot

    from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes

Secondary Outcomes (4)

  • time to eye opening

    from discontinuation of anesthetic agent to eye opening, up to 30 minutes

  • time to extubation

    form discontinuation of anesthetic agent to extubation, up to 30 minutes

  • Incidence of agitation during emergence period

    from discontinuation of anesthetic agent to 2 minutes after extubation

  • Mean arterial blood pressure

    from 5 minutes before anesthesia induction to end of anesthesia

Study Arms (2)

Remimazolam group

EXPERIMENTAL

receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam.

Drug: Remimazolam

Desflurane group

ACTIVE COMPARATOR

receives desflurane for the maintenance of general anesthesia.

Drug: Desflurane

Interventions

RemimazolamDRUG

General anesthesia was induced with 12 mg/kg/hr of intravenous remimazolam. When loss of consciousness was achieved, the infusion rate of remimazolam was reduced to 1mg/kg/hr for maintenance. At the end of surgery, 0.2 mg of flumazenil is administered.

Remimazolam group
DesfluraneDRUG

Desflurane (1 minimum alveolar concentration (MAC) of end-tidal desflurane concentration) is used for the maintenance of general anesthesia. Induction of general anesthesia is achieved with 1-2 mg/kg of intravenous propofol bolus.

Desflurane group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 19 and 75 years
  • American Society of Anesthesiologists physical status (ASA PS) of I-II
  • Patients undergoing elective closed reduction of nasal bone fracture

You may not qualify if:

  • Patient who cannot understand the process of this study
  • Cognitive, visual or hearing impairment
  • Chronic use of antipsychotic medications or medications for sleeping problem
  • Use of benzodiazepine
  • Patient with kidney or liver disease
  • Body mass index (BMI) \>30 kg/m\^2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

RECRUITING

MeSH Terms

Interventions

remimazolamDesflurane

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • So Young Lee, M.D.

    Daegu Catholic University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

So Young Lee, M.D.

CONTACT

+82-53-650-4885slamfor01@gmail.com

Jonghae Kim, M.D.

CONTACT

+82-53-650-4979usmed12@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 17, 2023

Study Start

March 22, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

KR(1)