None
Conditions
Interventions
High-Dose Group :The initial target-controlled plasma concentration of ciprofol for induction was set at 2.0 µg/mL.
Low-Dose Group :The initial target-controlled plasma concentration of ciprofol for induction was set at 1.2 µg/mL.
Sponsors
The First Affiliated Hospital of Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.A total of 80 hospitalized patients scheduled for non-emergency, non-cardiothoracic, and non-neurosurgical elective surgeries with an anticipated duration of >=1 hour, requiring general anesthesia with endotracheal intubation, will be included. 2.Patients planned for surgery types that may affect bispectral index monitoring are excluded. Eligible patients must meet the following criteria: male or female, age >65 years; 3.American Society of Anesthesiologists (ASA) physical status classification I–III; body mass index (BMI) >=18 and <=30 kg/m^2; 4.ability to comprehend the procedures and methods of this study, willingness to provide signed informed consent, and strict adherence to the trial protocol for study completion.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded: 1.Individuals with contraindications to general anesthesia or a previous history of adverse anesthesia events. 2.Known allergy to the excipients of Ciprofol Injection (soybean oil, glycerol, triglycerides, egg yolk lecithin, sodium oleate, and sodium hydroxide) or any component of the investigational drug(s). 3.Cross-allergy to halogenated anesthetics; or a history of jaundice or unexplained fever following previous use of halogenated agents. 4.Individuals with contraindications to propofol. 5.Unwillingness at screening/baseline to participate, or inability to cooperate and complete the study due to communication difficulties or severe hearing impairment. 6.Presence of severe uncontrolled cardiovascular disease at screening/baseline (including but not limited to: Adams-Stokes syndrome, severe coronary artery disease, unstable angina, myocardial infarction within the 3 months prior to screening, LVEF <30%, sick sinus syndrome, history of tachycardia/bradycardia requiring medication, third-degree atrioventricular block, etc.), acute severe respiratory disease, neurological and/or psychiatric disorders, a history of long-term use of analgesic or sedative medications, severe infection, or any other medical history deemed by the investigator as unsuitable for study participation. 7.Presence of airway management risks at screening/baseline, judged by the investigator as having a difficult airway or assessed as difficult intubation (modified Mallampati score of Class III or IV). 8.Participation in any drug clinical trial within 1 month prior to screening. 9.Any other condition considered by the investigator to render the subject unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Loss of consciousness effect-site concentration;Effect-site concentration at 1 minute prior to tracheal intubation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anesthesia induction time;Time to regain consciousness;Time to return of spontaneous respiration; | — |
Countries
China
Contacts
Public ContactJian-rong Ye
The First Affiliated Hospital of Xinjiang Medical University
Outcome results
None listed