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

This trial does not accept healthy volunteers

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 population

Patients scheduled for surgical procedures under general anesthesia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surgery commences in the morning.

    Other intervention

    The 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 intervention

    The afternoon group was defined as patients whose surgery commenced between 14:00 and 17:00 and concluded by 19:00.

Treatment groups

480 Participants
are divided into 4 treatment groups
Group A: Morning TCI group (MT)1 intervention
Group B: Afternoon TCI group (AT)1 intervention
Group C: Morning non-TCI/Manual group (MC)1 intervention
Group D: Afternoon non-TCI/Manual group (AC)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From the time of initial anesthetic drug administration until 5 minutes after completion of tracheal intubation (maximum duration limited to 20 minutes)

Secondary outcomes

1

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.

Time frame
From the time of initial anesthetic drug administration until 5 minutes after completion of tracheal intubation (maximum duration limited to 20 minutes)
2

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

Time frame
From 5 minutes after completion of tracheal intubation until the time of discontinuation of all anesthetic agents at the end of surgery, assessed up to 24 hours.
3

Incidence of MAP reduction > 20% from baseline during the anesthetic maintenance period

Incidence of MAP reduction \> 20% from baseline during the anesthetic maintenance period

Time frame
From 5 minutes after completion of tracheal intubation until the time of discontinuation of all anesthetic agents at the end of surgery, assessed up to 24 hours.
4

Incidence of MAP reduction > 30% from baseline during the anesthetic maintenance period

Incidence of MAP reduction \> 30% from baseline during the anesthetic maintenance period

Time frame
From 5 minutes after completion of tracheal intubation until the time of discontinuation of all anesthetic agents at the end of surgery, assessed up to 24 hours.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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