Ciprofol
Conditions
Interventions
cyprofol group:induction: intravenous push of cyprofol 0.3 mg/kg, maintenance: continuous pumping of cyprofol 0.4 mg/kg/h~2.4 mg/kg/h
propofol group:induction: intravenous push propofol 1.5mg/kg, maintenance: continuous pumping propofol 3.0mg/kg/h~12mg/kg/h
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: a) Patients undergoing elective laparoscopic surgery with an operative duration of =1 and =4h hours who are extubated under general anesthesia; b) Male or female, aged =18 and =80 years; c) ASA classification of I-III; d) BMI =18 and =30 kg/m2; e) Baseline vital signs meet the following criteria: - Pulse oximetry (SpO2) =95% while breathing air; - Systolic blood pressure (SBP) = 90 mmHg and = 160 mmHg; - Diastolic blood pressure (DBP) = 60 mmHg and = 100 mmHg; - Heart rate =55 and =100 beats/min; f) Be able to understand the procedures and methods of this study, be willing to sign the informed consent form and strictly comply with the trial protocol to complete the study.:
Exclusion criteria
Exclusion criteria: a. Those with contraindications to general anesthesia or a previous history of anesthetic accidents; b. Known hypersensitivity to excipients in propofol injection, excipients in cyprofol injection (soybean oil, glycerol, triglycerides, egg yolk lecithin, sodium oleate, and sodium hydroxide), benzodiazepines, opioids, cisatracurium, and their pharmaceutical ingredients; contraindications to propofol; c. History or evidence of the following increased risk for sedation/anesthesia prior to screening/at baseline: (1) History of cardiovascular disease: uncontrolled hypertension [systolic blood pressure (SBP) =170 mmHg and/or diastolic blood pressure (DBP) =105 mmHg without antihypertensive medication, or SBP >160 mmHg and/or DBP >100 mmHg after antihypertensive medication], severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the last 6 months before screening, history of tachycardia/bradycardia requiring medication, third degree AV block or QTcF interval =450 ms. Severe arrhythmia, heart failure, Adams-stokes syndrome, unstable angina pectoris, myocardial infarction within the last 6 months prior to screening, history of tachycardia/bradycardia requiring pharmacologic therapy, third degree AV block, or QTcF interval =450 ms (corrected for Fratricide's formula); (2) Respiratory history: respiratory insufficiency, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months prior to screening, acute respiratory infection with significant fever, wheezing, nasal congestion, and cough within 1 week prior to baseline; (3) History of cerebrovascular disease: craniocerebral injury, possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysm, history of cerebrovascular accidents; schizophrenia, mania, psychosis, long-term use of psychotropic medications, history of cognitive dysfunction; (4) Gastrointestinal history: gastrointestinal retention, active bleeding, conditions that may lead to reflux aspiration; (5) History of uncontrolled clinically significant hepatic, renal, hematologic, neurologic, or metabolic conditions that, in the judgment of the investigator, may make participation in the study inappropriate; (6) A history of alcohol abuse within the 3 months prior to the screening period, i.e., an average of >2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of liquor at 40% alcohol or 150 mL of wine); (7) History of substance abuse within 3 months prior to the screening period; d. The following respiratory management risks were identified during the screening period: (1) History of asthma, wheezing; (2) Those with sleep apnea syndrome; (3) History or family history of malignant hyperthermia; (4) Those who have experienced failed tracheal intubation; (5) Presence of a difficult airway as judged by the investigator at the time of screening or judged to be difficult to intubate (Modified Mars Score of IV); e. The use of any of the following medications or treatments was identified during the screening/baseline period: (1) Those who have participated in any drug clinical study within 1 month prior to screening; (2) Those who had used propofol, other sedative/anesthetic drugs and/or opioid analgesics or combination preparations containing analgesic components within 72 h before baseline; f. Subjects who, in the opinion of the investigator, have any other factors that make participation in this clinical study inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The awakening Restlessness score(RS);bispectral index; | — |
Secondary
| Measure | Time frame |
|---|---|
| QoR-15 score on the first day after surgery;Range of blood pressure change;Incidence of postoperative nausea and vomiting;injection pain;intraoperative awareness;Other adverse events and serious adverse events;Absence time; | — |
Countries
China
Contacts
Public ContactAn Haiyan
Peking University People's Hospital
Outcome results
None listed