Effect of Circadian Rhythm on the Sedative Efficacy and Recovery Quality of Ciprofol General Anesthesia: A Multi-Center Observational Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorJie Chen

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

Qualifiers

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 design

Treatments tested in this trial

  • Surgery commences in the morning.
  • Surgery commences in the afternoon.

Treatment groups

480 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

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