ChungAng University Gwangmyeong Hospital
Gyeonggi-do, Gwangmyeon-si, 14353, South Korea
Location status: Recruiting
NCT Number: NCT06507202
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Phase 4
Gyeonggi-do, Gwangmyeon-si, 14353, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
General anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil, and recovered with flumazenil.
Other names: Byfavo
General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil.
Other names: Fresofol
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.
Time frame: 1 minute
Measured at operating room, using a timer from the end of surgery
Time frame: 5 minutes
Measured from entering to exiting each units
Time frame: 6 hours
Including desaturation, laryngospasm, hypotension, bradycardia, hemodynamic agent administration, emergence agitation, headache, dizziness, somnolence, cough, shivering, postoperative nausea & vomiting
Time frame: 6 hours
11-point NRS (0-10); for the worst pain
Time frame: 30 minutes
Evaluated on a scale of 0 to 5
Time frame: 30 minutes
Evaluated on a scale of 0 to 10
Contact information is provided by the study sponsor or research team.
Chung-Ang University Gwangmyeong Hospital
Other
Comparison of Remimazolam Versus Propofol-based General Anesthesia on Postoperative Quality of Recovery in Patients Undergoing Ambulatory Upper Airway Surgery: a Randomized Controlled Trial
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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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