NCT06507202

Brief Summary

The purpose of this study is to compare the effects of remimazolam and propofol on postoperative recovery time, complications, and safety in patients undergoing ambulatory upper airway surgery under general anesthesia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 18, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2025

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

January 18, 2024

Last Update Submit

July 11, 2024

Conditions

Laryngeal DiseasePharyngeal DiseasesOral Cavity DiseaseNasal Disease

Keywords

remimazolamupper airway surgeryambulatory surgery

Outcome Measures

Primary Outcomes (1)

  • Fit-for-discharge time

    Evaluated on a scale of 0 to 10 through the Modified Post Anesthetic Discharge Scoring System (MPADSS); a score of 9 or higher meets the discharge criteria.

    15 minutes after surgery

Secondary Outcomes (6)

  • Time to eye opening, time to extubate, time to postanesthetic care unit (PACU) transfer

    1 minute

  • postanesthetic care unit (PCAU) stay time, Day surgery center stay time

    5 minutes

  • Incidence of adverse events

    6 hours

  • Postoperative pain score

    6 hours

  • modified Observer's Alertness/Sedation Scale (MOAA/S) at PACU arrival

    30 minutes

  • +1 more secondary outcomes

Study Arms (2)

Remimazolam group

EXPERIMENTAL

General anesthesia is induced by continuously injecting remimazolam (6 mg/kg/h) and remifentanil (2-6 ng/ml, target concentration controlled infusion) through an infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6 mg/kg is injected for endotracheal intubation, and anesthesia is maintained with remimazolam (1-2 mg/kg/hr) and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated with flumazenil and sugammadex.

Drug: Remimazolam

Propofol group

ACTIVE COMPARATOR

General anesthesia is induced by continuously injecting propofol (2-6 mg/ml, target concentration controlled injection) and remifentanil (2-6 ng/ml, target concentration controlled injection) using a TCI infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6mg/kg is injected for endotracheal intubation, and anesthesia is maintained with propofol and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated through sugammadex.

Drug: Propofol

Interventions

RemimazolamDRUG

General anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil, and recovered with flumazenil.

Also known as: Byfavo
Remimazolam group
PropofolDRUG

General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil.

Also known as: Fresofol
Propofol group

Eligibility Criteria

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

You may qualify if:

  • Adult patients (age 19 or older) undergoing ambulatory upper respiratory tract (nasal cavity, oral cavity, pharynx, larynx) surgery under general anesthesia
  • American Society of Anesthesiologists physical class classification I, II, and III

You may not qualify if:

  • Patients who refused to participate in the study
  • Pregnant patients
  • Patients with a history of hypersensitivity to drugs or additives used during surgery
  • Patients with acute narrow-angle glaucoma
  • Alcohol or drug dependent patients
  • Patients with Child-Pugh class C liver dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChungAng University Gwangmyeong Hospital

Gyeonggi-do, Gwangmyeon-si, 14353, South Korea

RECRUITING

MeSH Terms

Conditions

Laryngeal DiseasesPharyngeal DiseasesMouth DiseasesNose Diseases

Interventions

remimazolamPropofol

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Se-Hee Min

    Chung-Ang University Gwangmyeong Hospital

    STUDY CHAIR

Central Study Contacts

Se-Hee Min

CONTACT

+820222221534seiheemin@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
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

January 18, 2024

First Posted

July 18, 2024

Study Start

January 22, 2024

Primary Completion

January 22, 2025

Study Completion

March 22, 2025

Last Updated

July 18, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)