Laryngeal Disease, Nasal Disease, Oral Cavity Disease, Pharyngeal Diseases
Conditions
Keywords
remimazolam, upper airway surgery, ambulatory surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGRemimazolam
General anesthesia is induced and maintained by continuous infusion of remimazolam and remifentanil, and recovered with flumazenil.
DRUGPropofol
General anesthesia is induced and maintained by continuous infusion of propofol and remifentanil.
Sponsors
Chung-Ang University Gwangmyeong Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fit-for-discharge time | 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
| Measure | Time frame | Description |
|---|---|---|
| postanesthetic care unit (PCAU) stay time, Day surgery center stay time | 5 minutes | Measured from entering to exiting each units |
| Incidence of adverse events | 6 hours | Including desaturation, laryngospasm, hypotension, bradycardia, hemodynamic agent administration, emergence agitation, headache, dizziness, somnolence, cough, shivering, postoperative nausea & vomiting |
| Time to eye opening, time to extubate, time to postanesthetic care unit (PACU) transfer | 1 minute | Measured at operating room, using a timer from the end of surgery |
| modified Observer's Alertness/Sedation Scale (MOAA/S) at PACU arrival | 30 minutes | Evaluated on a scale of 0 to 5 |
| modified Aldrete score at PACU arrival | 30 minutes | Evaluated on a scale of 0 to 10 |
| Postoperative pain score | 6 hours | 11-point NRS (0-10); for the worst pain |
Countries
South Korea
Contacts
Primary ContactSe-Hee Min
Outcome results
None listed