ambulatory surgeries
Conditions
Interventions
experimental group:Anesthesia induction: Remazolam besylate 6mg/kg/h
Supplemental dose 2mg/kg/h
Anesthesia maintenance: The infusion rate of remazolam besylate is adjusted between 0.5-1.5 mg/kg/h. Stop dosing until the end of the procedure.
control group:Induction of anesthesia: propofol 2mg/kg
Supplemental dose 0.5mg/kg
Anesthetic maintenance: The recommended dosage range of propofol is 6-12 mg/kg/h. Stop dosing at the end of the procedure. The recommended dose of remifentanil during maint
About 30 minutes before the end of the operation, postoperative analgesia pretreatment was performed.
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients undergoing elective day surgery requiring general anesthesia; (2) Age 18-65 years old, gender is not limited; (3) American Society of Anesthesiologists ASA Class I-II; (4) Body mass index 18-29 kg/m2; (5) Non-emergency surgery whose operation time is expected to be less than 2 hours; (6) The patient voluntarily participated in the trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) The subject explicitly refuses to participate in the study; (2) Those who have contraindications to deep sedation/general anesthesia or have a history of sedation/anesthesia accidents in the past; (3) People who are known to be allergic to eggs, soy products, opioids and their relief drugs, propofol, remazolam benzoate, etc.; Propofol, benzodiazepines, opioids and their relief drugs contraindicated; (4) A history of severe liver, kidney, digestive, hematological, neuromuscular, or metabolic disease that the investigator judges may increase the risk of sedation/anesthesia and is not suitable for study participation; (5) Chronic pain, chronic use of analgesics, psychotropic drugs (including opioids, NSAIDs, sedatives, antidepressants), alcohol abuse, suspected abuse of narcotic analgesics or sedatives; (6) The following respiratory management risks were found during the screening period: a) History of asthma, wheezing; b) Patients with sleep apnea syndrome; c) A history or family history of malignant hyperthermia; d) Patients with tracheal intubation failure; e) A history of acute respiratory inflammation within 2 weeks with no cure; f) suffering from esophageal reflux disease; g) Difficult airway identified by the investigator or difficult intubation of the trachea during screening (modified Markov score level ?); (7) Participants in any drug clinical trial within 1 month before screening; Patients with opioid and sedative/narcotic use in the 3 days prior to treatment; (8) Pregnant women or women giving birth; (9) Electrocardiogram: heart rate <50 beats /min; (10) Taking monoamine oxidase inhibitors or antidepressants within 15 days; (11) Subjects who have any other factors deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of successful induction and maintenance of anesthesia; | — |
Secondary
| Measure | Time frame |
|---|---|
| vital signs; | — |
Countries
China
Contacts
Public ContactXi-Chen Dong
Guang'anmen Hospital, Chinese Academy of Chinese Medicine Sciences
Outcome results
None listed