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

Sponsor

Daegu Catholic University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05774366

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Remimazolam Drug: Desflurane	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Remimazolam group receives remimazolam for the maintenance of general anesthesia. At the end of surgery, flumazenil is administered as an antagonist of remimazolam.	Drug: Remimazolam 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.
Active Comparator: Desflurane group receives desflurane for the maintenance of general anesthesia.	Drug: Desflurane 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.

Arm

Intervention/Treatment

Experimental: Remimazolam group

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

Drug: Remimazolam

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.

Active Comparator: Desflurane group

receives desflurane for the maintenance of general anesthesia.

Drug: Desflurane

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.

Outcome Measures

Primary Outcome Measures

Time to follow verbal command [from discontinuation of anesthetic agent to response to a verbal command of moving participant's foot, up to 30 minutes]
Time between discontinuation of anesthetic agent and response to a verbal command of moving participant's foot

Secondary Outcome Measures

time to eye opening [from discontinuation of anesthetic agent to eye opening, up to 30 minutes]
Time between discontinuation of anesthetic agent and eye opening
time to extubation [form discontinuation of anesthetic agent to extubation, up to 30 minutes]
Time between discontinuation of anesthetic agent and extubation
Incidence of agitation during emergence period [from discontinuation of anesthetic agent to 2 minutes after extubation]
Ricker Sedation-Agitation Scale (RSAS) >4
Mean arterial blood pressure [from 5 minutes before anesthesia induction to end of anesthesia]
Mean arterial blood pressure measured in the operating room

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daegu Catholic University Medical Center	Daegu		Korea, Republic of	42472

Sponsors and Collaborators

Daegu Catholic University Medical Center

Investigators

Principal Investigator: So Young Lee, M.D., Daegu Catholic University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SO YOUNG LEE, Assistant professor, Daegu Catholic University Medical Center

ClinicalTrials.gov Identifier:

NCT05774366

Other Study ID Numbers:

CR-23-007-L

First Posted:

Mar 17, 2023

Last Update Posted:

Mar 22, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fractures, Bone

Desflurane

Study Results

No Results Posted as of Mar 22, 2023