Health TrialsbyHealthPanel

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

ConditionsLaryngeal DiseasePharyngeal DiseasesOral Cavity DiseaseNasal Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorChung-Ang University Gwangmyeong Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam

    Drug

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

  • Propofol

    Drug

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

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Remimazolam groupExperimental treatment 1 intervention
Group B: Propofol groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
15 minutes after surgery

Secondary outcomes

1

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

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

Time frame
1 minute
2

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

Measured from entering to exiting each units

Time frame
5 minutes
3

Incidence of adverse events

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

Time frame
6 hours
4

Postoperative pain score

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

Time frame
6 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chung-Ang University Gwangmyeong Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now