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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Recovery time in seconds
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing bronchoscopy endotracheal tumor resection or stenting of acquired tracheoesophageal fistula within a limited time
- •>18 Years
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
Arms & Interventions
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.
Intervention: Remimazolam (Drug)
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.
Intervention: Rocuronium (Drug)
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.
Intervention: Remifentanil (Drug)
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.
Intervention: oxycodone (Drug)
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.
Intervention: Sugammadex Sodium (Drug)
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.
Intervention: Flumazenil (Drug)
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.
Intervention: Propofol (Drug)
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.
Intervention: Rocuronium (Drug)
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.
Intervention: Remifentanil (Drug)
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.
Intervention: oxycodone (Drug)
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.
Intervention: Sugammadex Sodium (Drug)
Outcomes
Primary Outcomes
Recovery time in seconds
Time Frame: postoperative, 2 hours
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
Secondary Outcomes
- 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)
- Intraoperative heart rate in beats per minute(Intraoperative，4hours)
- The incidence of postoperative vomiting in rate(postoperative，24 hours)
Investigators
Xie Kangjie
Clinical Professor
Zhejiang Cancer Hospital