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Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture

Primary Purpose

Anesthesia

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Remimazolam

Desflurane

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

Daegu Catholic University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam group

Desflurane group

Arm Description

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

receives desflurane for the maintenance of general anesthesia.

Outcomes

Primary Outcome Measures

Time to follow verbal command

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

Secondary Outcome Measures

time to eye opening

Time between discontinuation of anesthetic agent and eye opening

time to extubation

Time between discontinuation of anesthetic agent and extubation

Incidence of agitation during emergence period

Ricker Sedation-Agitation Scale (RSAS) >4

Mean arterial blood pressure

Mean arterial blood pressure measured in the operating room

Full Information

NCT ID

NCT05774366

First Posted

March 7, 2023

Last Updated

September 6, 2023

Sponsor

Daegu Catholic University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05774366

Brief Title

Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture

Official Title

Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 22, 2023 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Daegu Catholic University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anesthesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Remimazolam group

Arm Type

Experimental

Arm Description

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

Arm Title

Desflurane group

Arm Type

Active Comparator

Arm Description

receives desflurane for the maintenance of general anesthesia.

Intervention Type

Drug

Intervention Name(s)

Remimazolam

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Desflurane

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to follow verbal command

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

time to eye opening

Description

Time between discontinuation of anesthetic agent and eye opening

Time Frame

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

Title

time to extubation

Description

Time between discontinuation of anesthetic agent and extubation

Time Frame

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

Title

Incidence of agitation during emergence period

Description

Ricker Sedation-Agitation Scale (RSAS) >4

Time Frame

from discontinuation of anesthetic agent to 2 minutes after extubation

Title

Mean arterial blood pressure

Description

Mean arterial blood pressure measured in the operating room

Time Frame

from 5 minutes before anesthesia induction to end of anesthesia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

So Young Lee, M.D.

Phone

+82-53-650-4885

slamfor01@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jonghae Kim, M.D.

Phone

+82-53-650-4979

usmed12@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

So Young Lee, M.D.

Organizational Affiliation

Daegu Catholic University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Daegu Catholic University Medical Center

City

Daegu

ZIP/Postal Code

42472

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

So Young Lee, M.D.

Phone

+82-53-650-4885

slamfor01@gmail.com

First Name & Middle Initial & Last Name & Degree

Jong Hae Kim, M.D.

Phone

+82-53-650-4979

usmed12@gmail.com

First Name & Middle Initial & Last Name & Degree

So Young Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Jong Hae Kim, M.D.

12. IPD Sharing Statement

Learn more about this trial

Comparative Study of Recovery Characteristics Between Remimazolam Anesthesia With Flumazenil and Desflurane Anesthesia for Closed Reduction of Nasal Bone Fracture

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