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

NCT ID: NCT05468671

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2022-09-08

Brief Summary

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.

Conditions

Endobronchial Metastases; Bronchoesophageal Fistula; General Anesthetic Drug Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.Group R was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

Remimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil. It acts on GABA receptors like midazolam and has organ-independent metabolism like remifentanil.

Rocuronium

Intervention Type: DRUG

Rocuronium is a non-depolarizing neuromuscular blocker

Remifentanil

Intervention Type: DRUG

Remifentanil is an esterase-metabolized opioid

oxycodone

Intervention Type: DRUG

Oxycodone is an opiate painkiller.

Sugammadex Sodium

Intervention Type: DRUG

Sugammadex sodium is an organic sodium salt that is the octasodium salt of sugammadex. Used for reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery

Flumazenil

Intervention Type: DRUG

Flumazenil is used to reverse the effects of a benzodiazepine

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.Group P was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.

Rocuronium

Intervention Type: DRUG

Rocuronium is a non-depolarizing neuromuscular blocker

Remifentanil

Intervention Type: DRUG

Remifentanil is an esterase-metabolized opioid

oxycodone

Intervention Type: DRUG

Oxycodone is an opiate painkiller.

Sugammadex Sodium

Intervention Type: DRUG

Sugammadex sodium is an organic sodium salt that is the octasodium salt of sugammadex. Used for reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery

Interventions

Remimazolam

Remimazolam is a new drug innovation in anesthesia. It combines the properties of two unique drugs already established in anesthesia - Midazolam and remifentanil. It acts on GABA receptors like midazolam and has organ-independent metabolism like remifentanil.

Intervention Type: DRUG

Propofol

Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.

Intervention Type: DRUG

Rocuronium

Rocuronium is a non-depolarizing neuromuscular blocker

Intervention Type: DRUG

Remifentanil

Remifentanil is an esterase-metabolized opioid

Intervention Type: DRUG

oxycodone

Oxycodone is an opiate painkiller.

Intervention Type: DRUG

Sugammadex Sodium

Sugammadex sodium is an organic sodium salt that is the octasodium salt of sugammadex. Used for reversal of neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery

Intervention Type: DRUG

Flumazenil

Flumazenil is used to reverse the effects of a benzodiazepine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xie Kangjie

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hanzhou, , China

Countries

China

Other Identifiers

IRB-2020-406

Identifier Type: -

Identifier Source: org_study_id