General anesthesia
Conditions
Interventions
Experimental group:fospropofol
Control group:propofol
Sponsors
Peking University Shougang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-65 years old, gender unlimited, weight kg=(height -100)±15%; (2) American Society of Anesthesiologists (ASA) Levels I and II; (3) Subjects undergoing elective general anesthesia cholecystectomy or cholecystolithotomy; (4) non-acute hospitalized subjects who have undergone proper preoperative preparation; (5) Vital signs: respiratory rate =10 and =24 times/min; Blood oxygen saturation (SpO2) =95% when breathing air; Systolic blood pressure (SBP) =90mmHg and =160mmHg; Diastolic blood pressure (DBP) =60mmHg and =100mmHg; Heart rate =55 and =100 beats/min; (6) Can understand the process and method of this study, voluntarily participate in and sign the informed consent
Exclusion criteria
Exclusion criteria: (1) Those who have contraindications to general anesthesia or have a history of anesthesia accidents; (2) Known or suspected allergic or contraindicated to propofol injection and excipients, benzodiazepines, opioids, muscle relaxants, etc.; (3) Patients with craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction; (4) Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult airway, or determination of tracheal intubation difficulty (modified Markov score level III or IV) (5) uncontrolled diabetes or hypertension; (6) severe liver dysfunction or severe renal insufficiency; (7) A history of alcoholism or drug dependence; (8) Abuse or long-term use of narcotic, sedative and analgesic drugs; (9) People with a history of mental illness; (10) Participants in any drug clinical trial within 1 month before screening; (11) Pregnant and lactating women; The reluctance of fertile women or men to use contraception throughout the trial; Subjects (including male subjects) who plan to become pregnant within 1 month after the trial; (12) Subjects who have any other factors deemed unsuitable for participation in this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of anesthesia induction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Systolic blood pressure;Diastolic blood pressure;Mean pressure;Heart rate;Bifrequency index (BIS);Duration of successful induction of anesthesia;Length of absence of eyelash reflex;Operation duration;Intubation duration;PACU stay time;Study drug and alternative drug use;Evaluation of satisfaction degree of anesthesiologists; | — |
Countries
China
Contacts
Public ContactQianqian Guo
Peking University Shougang Hospital
Outcome results
None listed