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

NCT05468671 | Completed Phase 4

• 1 other identifier: IRB-2020-406
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Recovery time in seconds

  Taking the stop of general anesthesia as the starting point for timing, the time for the patient to correctly complete the three commands of nodding, mouth opening and tongue extension is recorded, with seconds as the timing unit

  postoperative, 2 hours

Secondary Outcomes (7)

• Modified Brice Questionnaire in YES or NO

  postoperative，24 hours

• Intraoperative mean arterial blood pressure in mmHg

  Intraoperative，4hours

• Perioperative Nutrition Status Assessment Scale (PONS) in YES or NO

  Baseline, 1 year

• Onset time in seconds

  Induction of anesthesia，10 minutes

• The incidence of Postoperative delirium in rate

  postoperative，24 hours

Study Arms (2)

Remazolam general anesthesia group (R group)

EXPERIMENTAL

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.

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

Propofol general anesthesia control group (P group)

ACTIVE COMPARATOR

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.

Drug: Propofol; Drug: Rocuronium; Drug: Remifentanil; Drug: oxycodone; Drug: Sugammadex Sodium

Interventions

Remimazolam 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.

Remazolam general anesthesia group (R group)

Propofol DRUG

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

Propofol general anesthesia control group (P group)

Rocuronium DRUG

Rocuronium is a non-depolarizing neuromuscular blocker

Propofol general anesthesia control group (P group); Remazolam general anesthesia group (R group)

Remifentanil DRUG

Remifentanil is an esterase-metabolized opioid

Propofol general anesthesia control group (P group); Remazolam general anesthesia group (R group)

oxycodone DRUG

Oxycodone is an opiate painkiller.

Propofol general anesthesia control group (P group); Remazolam general anesthesia group (R group)

Sugammadex Sodium 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

Propofol general anesthesia control group (P group); Remazolam general anesthesia group (R group)

Flumazenil DRUG

Flumazenil is used to reverse the effects of a benzodiazepine

Remazolam general anesthesia group (R group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hanzhou, China

Location

MeSH Terms

Interventions

remimazolam; Propofol; Rocuronium; Remifentanil; Oxycodone; Sugammadex; Flumazenil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 21, 2022
• Study Start: January 4, 2021
• Primary Completion: August 4, 2021
• Study Completion: September 8, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)