Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery
NCT ID: NCT06507202
Last Updated: 2024-07-18
Study Results
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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RECRUITING
PHASE4
116 participants
INTERVENTIONAL
2024-01-22
2025-03-22
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Remimazolam
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.
Propofol
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.
Propofol
General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists physical class classification I, II, and III
Exclusion Criteria
* 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
19 Years
ALL
No
Sponsors
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Chung-Ang University Gwangmyeong Hospital
OTHER
Responsible Party
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Se-Hee Min
Assistant professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2311123132
Identifier Type: -
Identifier Source: org_study_id
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