About this trial
At the initiation of induction for non-intubated general anesthesia, ciprofol or propofol will be administered intravenously at a rate of 10 mL/min. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale will be used to evaluate sedation depth. This study aims to assess the effects of ciprofol and propofol on hemodynamics and respiratory function in elderly patients undergoing non-intubated general anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective non-intubated general anesthesia
Age ranging from 65 to 80 years old
American Society of Anesthesiologists (ASA) physical status class I-III
Written informed consent signed by the patient or legal guardian
Disqualifiers
Confirmed allergy to propofol, ciprofol or their excipients
Severe cardiovascular diseases (uncontrolled hypertension, heart failure, severe arrhythmia, etc.)
Severe respiratory diseases (chronic obstructive pulmonary disease, obstructive sleep apnea syndrome, etc.)
Severe hepatic or renal insufficiency
Trial design
Parallel
Treatments tested in this trial
Propofol Injection
DrugIntravenous administration, injection rate of 10 ml/min, continuous and uniform infusion until the patient's MOAA/S sedation score is ≤1 point. This is used for the induction of general anesthesia in short-duration medical procedures for elderly individuals aged 65-80 without intubation and with spontaneous respiration
Ciprofol Injection
DrugIntravenous administration, injection rate of 10 ml/min, continuous and uniform infusion until the patient's MOAA/S sedation score is ≤1 point. This is used for the induction of general anesthesia in short-duration medical procedures for elderly individuals aged 65-80 without intubation and with spontaneous respiration
Treatment groups
Trial outcomes
Primary outcomes
Comparison of hemodynamic and respiratory function changes within 5 minutes of anesthesia induction
The primary objective of this study was to evaluate the degree of circulatory and respiratory suppression induced by two types of anesthesia drugs in elderly patients. Continuous, non-invasive monitoring was conducted on the baseline conditions before administration for patients aged 65 to 80 undergoing short procedures without intubation and with spontaneous respiration under general anesthesia. Additionally, measurements were taken at 1 minute, 2 minutes, 3 minutes, 4 minutes, and 5 minutes after induction to assess circulatory and respiratory functions. Statistical analysis was performed to compare the changes in Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, cardiac output , stroke volume, systemic vascular resistance , peripheral oxygen saturation, respiratory rate , end-tidal carbon dioxid within the 5-minute induction period. A comprehensive assessment of the dual safety of circulatory and respiratory systems was conducted
Secondary outcomes
Brain electrical activity sedation depth (BIS)
lowest BIS value throughout the induction process, BIS value immediately upon loss of consciousness.
incidence of induction period circulatory/respiratory adverse events
Proportion of adverse events, including low blood pressure, bradycardia, inadequate ventilation, apnea, and hypoxemia, occurring within 5 minutes of induction
Sponsors and contacts
Click on the lead sponsor to view all of their trials.