Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy

University of Chinese Academy Sciences

Status and phase: Completed; Phase 4

Conditions: Bronchoesophageal Fistula; General Anesthetic Drug Adverse Reaction; Endobronchial Metastases

Treatments: Drug: Sugammadex Sodium; Drug: Flumazenil; Drug: Rocuronium; Drug: Propofol; Drug: Remifentanil; Drug: oxycodone; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05468671

IRB-2020-406

Details and patient eligibility

About

This study is a prospective, randomized, controlled trial. In this study, 30 patients who underwent endotracheal tumor resection under rigid bronchoscope or stent placement for acquired tracheoesophageal fistula were selected as the subjects. The patients were randomly divided into remazolam general anesthesia group (R group) and propofol general anesthesia control group (P group). Remazolam general anesthesia group (R group): Remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction. Propofol general anesthesia control group (P group): Propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia. After induction, high-frequency jet ventilation was used in both groups, the respiratory rate was 30-60 times/min, the inspiratory-to-breath ratio was 1:2, and the driving pressure was 0.8-1.0 KPa. Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance. Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance. The dosage of propofol or remazolam was adjusted according to BIS and intraoperative hemodynamic changes. Rocuronium bromide 10 mg was added every half hour. Intraoperative application of vasoactive drugs to maintain mean arterial pressure above 60mmHg to avoid perioperative hypotension. Blood oxygen saturation and end-tidal carbon dioxide were monitored to avoid perioperative hypoxemia and hypercapnia, and warm measures were used to maintain the patient's intraoperative body temperature above 36.0°C. After surgery, group R was treated with sugammadex sodium 2-4 mg/kg to antagonize rocuronium bromide, and 0.5 mg of flumazenil was used to antagonize remazolam by intravenous injection; group P was treated with sugammadex 2-4 mg/kg to antagonize rocuronium.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing bronchoscopy endotracheal tumor resection or stenting of acquired tracheoesophageal fistula within a limited time
• >18 Years
• ASA Ⅱ-Ⅳ

Exclusion criteria

• <18Years
• Refuse to participate
• A history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis;
• Severe hepatic dysfunction (Child-Pugh class C)
• Severe renal dysfunction (requiring dialysis)
• Patients with ASA grade Ⅴ and above
• Emergency Surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Remazolam general anesthesia group (R group)

Experimental group

Description:

Remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction.Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance.

Treatment:

Drug: Flumazenil

Drug: Rocuronium

Drug: Remifentanil

Drug: Remimazolam

Drug: Sugammadex Sodium

Drug: oxycodone

Propofol general anesthesia control group (P group)

Active Comparator group

Description:

Propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia.Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance.

Treatment:

Drug: Rocuronium

Drug: Propofol

Drug: Remifentanil

Drug: Sugammadex Sodium

Drug: oxycodone