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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
116
General anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil, and recovered with flumazenil.
General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil.
ChungAng University Gwangmyeong Hospital
Gyeonggi-do, Gwangmyeon-si, South Korea
RECRUITINGFit-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
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
postanesthetic care unit (PCAU) stay time, Day surgery center stay time
Measured from entering to exiting each units
Time frame: 5 minutes
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
Postoperative pain score
11-point NRS (0-10); for the worst pain
Time frame: 6 hours
modified Observer's Alertness/Sedation Scale (MOAA/S) at PACU arrival
Evaluated on a scale of 0 to 5
Time frame: 30 minutes
modified Aldrete score at PACU arrival
Evaluated on a scale of 0 to 10
Time frame: 30 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.