Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery

NCT ID: NCT06507202

Last Updated: 2024-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-22

Study Completion Date

2025-03-22

Brief Summary

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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.

Detailed Description

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Patients scheduled for ambulatory upper airway (including nasal cavity, oral cavity, pharynx, larynx) surgery and who agree to participate in the study will be randomly assigned to the Remimazolam group and the Propofol group. In the Remimazolam group, general anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil. Once the surgery is completed, general anesthesia is recovered with flumazenil. In the Propofol group, general anesthesia is induced and maintained by continuous infusion of propofol and remifentanil using a target concentration controlled infusion method. In both groups, rocuronium is used for neuromuscular blokade, and sugammadex is used for reversal of neuromuscular blockade.

When the surgery is completed, recovery time, occurrence of adverse events, and anesthesia recovery indicators are examined in 3 stages: in the operating room, while staying in the post-anesthesia care unit(PACU), and while staying in the day surgery center.

Conditions

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Laryngeal Disease Pharyngeal Diseases Oral Cavity Disease Nasal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Remimazolam group

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.

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

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

Propofol group

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Remimazolam

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Other Intervention Names

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Byfavo Fresofol

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung-Ang University Gwangmyeong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Se-Hee Min

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Se-Hee Min

Role: STUDY_CHAIR

Chung-Ang University Gwangmyeong Hospital

Locations

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ChungAng University Gwangmyeong Hospital

Gyeonggi-do, Gwangmyeon-si, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Se-Hee Min

Role: CONTACT

+820222221534

Facility Contacts

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Seihee Min

Role: primary

821054004892

Other Identifiers

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2311123132

Identifier Type: -

Identifier Source: org_study_id

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