Clinical trial NCT05468671: Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endobronchial Metastases
Bronchoesophageal Fistula
General Anesthetic Drug Adverse Reaction
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Recovery time in seconds
timeFrame: postoperative, 2 hours
Secondary outcomes:
measure: Modified Brice Questionnaire in YES or NO
timeFrame: postoperative，24 hours
measure: Intraoperative mean arterial blood pressure in mmHg
timeFrame: Intraoperative，4hours
measure: Perioperative Nutrition Status Assessment Scale (PONS) in YES or NO
timeFrame: Baseline, 1 year
measure: Onset time in seconds
timeFrame: Induction of anesthesia，10 minutes
measure: The incidence of Postoperative delirium in rate
timeFrame: postoperative，24 hours
measure: Intraoperative heart rate in beats per minute
timeFrame: Intraoperative，4hours
measure: The incidence of postoperative vomiting in rate
timeFrame: postoperative，24 hours
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: Zhejiang Cancer Hospital
Study officials:
References: