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NCT Number: NCT07686432

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

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.

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Key information

Conditions

Circadian Rhythm Anesthetics Adverse Reaction Ciprofol Hemodynamic Instability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Willing to participate and having provided signed informed consent.

Exclusion criteria

  • 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.
  • Recent (within 3 months) history of shift work, transmeridian travel, or other conditions that may cause circadian rhythm disruption.
  • Pregnant or lactating women.
  • Any other condition deemed by the investigator as unsuitable for participation in this study.

Treatment and study plan

Surgery commences in the morning.

Other

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

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

Primary outcomes

  1. Incidence of hypotension during the induction period

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

    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

  1. 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)

    Incidence of mean arterial pressure decreasing by >30% from baseline during the induction period and lasting for ≥1 minute.

  2. Incidence of MAP staying below 65 mmHg for at least 1 minute during the 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.

    Incidence of MAP staying below 65 mmHg for at least 1 minute throughout anesthetic maintenance

  3. 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.

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

  4. 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.

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

  5. Total administered dose of vasoactive agents

    Time frame: From the time of initial anesthetic drug administration until the time of discontinuation of anesthetic infusion at the end of surgery,assessed up to 24 hours.

    Total administered dose of various vasoactive agents during the entire anesthetic period

  6. Incidence of hypertension throughout anesthesia

    Time frame: From the time of initial anesthetic drug administration until the time of discontinuation of anesthetic infusion at the end of surgery,assessed up to 24 hours.

    Incidence of hypertension throughout anesthesia.Hypertension is defined when blood pressure rises by > 30% from baseline MAP, or SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg, and persists for ≥ 1 minute.

  7. Time to successful anesthetic induction

    Time frame: From the time of initial anesthetic drug administration until the time of disappearance of the patient's eyelash reflex, assessed up to 20 minutes.

    Time to loss of eyelash reflex following ciprofol administration

  8. Time to emergence

    Time frame: From the time of discontinuation of anesthetic infusion until the time of the patient's first eye opening, assessed up to 2 hours.

    Time from discontinuation of anesthesia to the patient's first eye opening

  9. Time to extubation

    Time frame: From the time of discontinuation of anesthetic infusion until the time of tracheal tube removal, assessed up to 2 hours.

    Time from discontinuation of anesthesia to tracheal extubation

  10. Bispectral Index

    Time frame: From the patient's awake state before anesthetic induction until the time when the patient emerges from anesthesia and leaves the operating room for the ward after surgery, assessed up to 24 hours.

    recorded BIS values at pre-induction, at loss of consciousness, at tracheal intubation, every 15 minutes intraoperatively, at the end of surgery, and at recovery of consciousness.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Chen

CONTACT

[email protected]

00-86-023-13527517763

Sponsors and collaborators

Lead sponsor

Jie Chen

Other

Collaborators

  • Chongqing Medical University
  • People's Hospital of Chongqing Liangjiang New Area.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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