About this trial
The goal of this multi-center observational study is to learn about the effect of circadian rhythm (morning vs. afternoon surgery) on the sedative efficacy, hemodynamic stability (especially induction-associated hypotension), and recovery quality of ciprofol general anesthesia in adult patients undergoing elective non-cardiac and non-cranial surgery, comparing target-controlled infusion (TCI) and non-TCI administration modes.
The main question it aims to answer is:
Does circadian rhythm (time of surgery: morning vs. afternoon) affect the sedative efficacy, incidence of induction-associated hypotension, and recovery quality of ciprofol general anesthesia? Eligible patients aged 18-65 years with ASA physical status I-II and BMI 18-30 kg/m² undergoing elective general anesthesia for non-cardiac and non-cranial surgery (duration 1-2 hours) will be grouped by anesthesia start time (morning: 08:00-11:00; afternoon: 14:00-17:00) and receive ciprofol induction and maintenance via TCI or non-TCI infusion. Perioperative data including hemodynamic changes, ciprofol dosage, recovery time, and adverse events will be recorded and analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-65 years, with ASA physical status I-II.
Body Mass Index (BMI) between 18-30 kg/m².
Scheduled for elective non-cardiac and non-intracranial surgery under general anesthesia, with an expected operative duration of 1-2 hours.
Morning group: surgery start time between 08:00 and 11:00, with completion no later than 13:00; Afternoon group: surgery start time between 14:00 and 17:00, with completion no later than 19:00.
Disqualifiers
Severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR < 30 ml/min/1.73m²).
Severe cardiovascular, respiratory, or neurological diseases.
Long-term use of sedative-hypnotics, anxiolytics, antidepressants, or glucocorticoids.
Known allergy to ciprofol, propofol, or their excipients.
Trial population
Patients scheduled for surgical procedures under general anesthesia.
Trial design
Cohort
Prospective
Treatments tested in this trial
Surgery commences in the morning.
Other interventionThe morning group was defined as patients whose surgery commenced between 08:00 and 11:00 and concluded by 13:00.
Surgery commences in the afternoon.
Other interventionThe afternoon group was defined as patients whose surgery commenced between 14:00 and 17:00 and concluded by 19:00.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of hypotension during the induction period
The incidence of hypotension was assessed during anesthetic induction with ciprofol. Hypotension is defined as a mean arterial pressure (MAP) \< 65 mmHg at any time from the initiation of anesthetic induction to 5 minutes after tracheal intubation, and/or a MAP reduction of over 20% relative to baseline, with a duration of ≥ 1 minute.
Secondary outcomes
Incidence of mean arterial pressure decreasing by >30% from baseline during the induction period and lasting for ≥1 minute.
Incidence of mean arterial pressure decreasing by \>30% from baseline during the induction period and lasting for ≥1 minute.
Incidence of MAP staying below 65 mmHg for at least 1 minute during the anesthetic maintenance
Incidence of MAP staying below 65 mmHg for at least 1 minute throughout anesthetic maintenance
Incidence of MAP reduction > 20% from baseline during the anesthetic maintenance period
Incidence of MAP reduction \> 20% from baseline during the anesthetic maintenance period
Incidence of MAP reduction > 30% from baseline during the anesthetic maintenance period
Incidence of MAP reduction \> 30% from baseline during the anesthetic maintenance period
Locations
Sponsors and contacts
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Jie Chen
Lead sponsor
The Second Affiliated Hospital of Chongqing Medical University
Sponsor institution
People's Hospital of Chongqing Liangjiang New Area.
Collaborator
Chongqing Medical University
Collaborator
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