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

Department of Anesthesiology, Cancer Hospital of the University of Chinese Academy of Sciences（Zhejiang Cancer Hospital), Research Center for Neuro-Oncology Interaction , Institute of Basic Medicine and Cancer, Chinese Academy of Sciences

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.

Study Overview

• Status: Completed
• Conditions: Endobronchial Metastases; Bronchoesophageal Fistula; General Anesthetic Drug Adverse Reaction
• Intervention / Treatment: Drug: Remimazolam; Drug: Rocuronium; Drug: Remifentanil; Drug: oxycodone; Drug: Sugammadex Sodium; Drug: Flumazenil; Drug: Propofol

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hanzhou, China
    • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Drug: Rocuronium; Rocuronium is a non-depolarizing neuromuscular blocker; Drug: Remifentanil; Remifentanil is an esterase-metabolized opioid; Drug: oxycodone; Oxycodone is an opiate painkiller.; 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; Drug: Flumazenil; Flumazenil is used to reverse the effects of a benzodiazepine
Active Comparator: 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.	Drug: Rocuronium; Rocuronium is a non-depolarizing neuromuscular blocker; Drug: Remifentanil; Remifentanil is an esterase-metabolized opioid; Drug: oxycodone; Oxycodone is an opiate painkiller.; 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; Drug: Propofol; Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Brice Questionnaire in YES or NO	Modified Brice interview over quality assurance techniques in detecting intraoperative awareness.	postoperative，24 hours
Intraoperative mean arterial blood pressure in mmHg	Fluctuations in intraoperative systolic, diastolic pressures and mean arterial pressure will be recorded	Intraoperative，4hours
Perioperative Nutrition Status Assessment Scale (PONS) in YES or NO	PONS is a modified version of the malnutrition universal screening tool and determines the presence of nutrition risk based on BMI, recent body weight loss, decrement of dietary intake, and preoperative albumin concentration.	Baseline, 1 year
Onset time in seconds	The time from the start of peripheral intravenous injection of general anesthetic to the patient's loss of consciousness. Time is measured in seconds.	Induction of anesthesia，10 minutes
The incidence of Postoperative delirium in rate	The proportion of cases of postoperative delirium in the enrolled patients	postoperative，24 hours
Intraoperative heart rate in beats per minute	Fluctuations in intraoperative heart rate will be recorded	Intraoperative，4hours
The incidence of postoperative vomiting in rate	The proportion of cases of postoperative vomiting in the enrolled patients	postoperative，24 hours

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathological Conditions, Anatomical; Fistula; Drug-Related Side Effects and Adverse Reactions; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Protective Agents; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Neuromuscular Agents; Antidotes; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Remifentanil; Propofol; Oxycodone; Rocuronium; Flumazenil
• Other Study ID Numbers: IRB-2020-406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No