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NCT Number: NCT06507202

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ChungAng University Gwangmyeong Hospital

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

Location status: Recruiting

Location contact

Seihee Min

CONTACT

[email protected]

821054004892

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam

Drug

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

Other names: Byfavo

Propofol

Drug

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

Other names: Fresofol

Primary outcomes

  1. Fit-for-discharge time

    Time frame: 15 minutes after surgery

    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.

Secondary outcomes

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

    Time frame: 1 minute

    Measured at operating room, using a timer from the end of surgery

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

    Time frame: 5 minutes

    Measured from entering to exiting each units

  3. Incidence of adverse events

    Time frame: 6 hours

    Including desaturation, laryngospasm, hypotension, bradycardia, hemodynamic agent administration, emergence agitation, headache, dizziness, somnolence, cough, shivering, postoperative nausea & vomiting

  4. Postoperative pain score

    Time frame: 6 hours

    11-point NRS (0-10); for the worst pain

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

    Time frame: 30 minutes

    Evaluated on a scale of 0 to 5

  6. modified Aldrete score at PACU arrival

    Time frame: 30 minutes

    Evaluated on a scale of 0 to 10

Study contacts

Contact information is provided by the study sponsor or research team.

Se-Hee Min

CONTACT

[email protected]

+820222221534

Sponsors and collaborators

Lead sponsor

Chung-Ang University Gwangmyeong Hospital

Other

Registry information

Official study title

Comparison of Remimazolam Versus Propofol-based General Anesthesia on Postoperative Quality of Recovery in Patients Undergoing Ambulatory Upper Airway Surgery: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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