Clinical trial NCT06507202: Comparison of Remimazolam and Propofol for Recovery of Ambulatory Upper Airway Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Laryngeal Disease
Pharyngeal Diseases
Oral Cavity Disease
Nasal Disease
Keywords: remimazolam
upper airway surgery
ambulatory surgery
Lead sponsor: Chung-Ang University Gwangmyeong Hospital
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fit-for-discharge time
timeFrame: 15 minutes after surgery
Secondary outcomes:
measure: Time to eye opening, time to extubate, time to postanesthetic care unit (PACU) transfer
timeFrame: 1 minute
measure: postanesthetic care unit (PCAU) stay time, Day surgery center stay time
timeFrame: 5 minutes
measure: Incidence of adverse events
timeFrame: 6 hours
measure: Postoperative pain score
timeFrame: 6 hours
measure: modified Observer's Alertness/Sedation Scale (MOAA/S) at PACU arrival
timeFrame: 30 minutes
measure: modified Aldrete score at PACU arrival
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: ChungAng University Gwangmyeong Hospital
state: Gwangmyeon-si
Study officials:
affiliation: Chung-Ang University Gwangmyeong Hospital
name: Se-Hee Min
role: STUDY_CHAIR
References: