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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endobronchial Metastases, Bronchoesophageal Fistula, General Anesthetic Drug Adverse Reaction

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Propofol
* Drug: Rocuronium
* Drug: Remifentanil
* Drug: oxycodone
* Drug: Sugammadex Sodium
* Drug: Flumazenil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remazolam general anesthesia group (R group)<br>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<br>* 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.<br>Drug: Rocuronium<br>* Rocuronium is a non-depolarizing neuromuscular blocker<br>Drug: Remifentanil<br>* Remifentanil is an esterase-metabolized opioid<br>Drug: oxycodone<br>* Oxycodone is an opiate painkiller.<br>Drug: Sugammadex Sodium<br>* 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<br>Drug: Flumazenil<br>* Flumazenil is used to reverse the effects of a benzodiazepine<br>|
| Active Comparator: Propofol general anesthesia control group (P group)<br>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<br>* Propofol is used to put you to sleep and keep you asleep during general anesthesia for surgery or other medical procedures.<br>Drug: Rocuronium<br>* Rocuronium is a non-depolarizing neuromuscular blocker<br>Drug: Remifentanil<br>* Remifentanil is an esterase-metabolized opioid<br>Drug: oxycodone<br>* Oxycodone is an opiate painkiller.<br>Drug: Sugammadex Sodium<br>* 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<br>|

What is the study measuring?
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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 |