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

Chung-Ang University Gwangmyeong Hospital

Status and phase: Enrolling; Phase 4

Conditions: Nasal Disease; Laryngeal Disease; Oral Cavity Disease; Pharyngeal Diseases

Treatments: Drug: Propofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06507202

2311123132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

116 participants in 2 patient groups

Remimazolam group

Experimental group

Description:

General anesthesia is induced by continuously injecting remimazolam (6 mg/kg/h) and remifentanil (2-6 ng/ml, target concentration controlled infusion) through an infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6 mg/kg is injected for endotracheal intubation, and anesthesia is maintained with remimazolam (1-2 mg/kg/hr) and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated with flumazenil and sugammadex.

Treatment:

Drug: Remimazolam

Propofol group

Active Comparator group

Description:

General anesthesia is induced by continuously injecting propofol (2-6 mg/ml, target concentration controlled injection) and remifentanil (2-6 ng/ml, target concentration controlled injection) using a TCI infusion pump. Afterwards, when the patient loses consciousness, rocuronium 0.6mg/kg is injected for endotracheal intubation, and anesthesia is maintained with propofol and remifentanil after endotracheal intubation. When the surgery is completed, all anesthetic drugs being administered are stopped, and general anesthesia is terminated through sugammadex.

Treatment:

Drug: Propofol