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

NCT07686432 | Not Yet Recruiting

• 1 other identifier: 2026EC083
• Study Type: observational
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Circadian Rhythm; Ciprofol; Hemodynamic Instability; Anesthetics Adverse Reaction

Outcome Measures

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.

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

Secondary Outcomes (10)

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

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

• Incidence of MAP staying below 65 mmHg for at least 1 minute during the anesthetic maintenance

  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

  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

  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.

• Total administered dose of vasoactive agents

  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.

Study Arms (4)

Morning TCI group (MT)

The surgery start time was between 08:00 and 11:00, and the end time did not exceed 13:00. Patients in the TCI group underwent anesthetic induction and maintenance with ciprofol via target-controlled infusion (TCI) operated in Keo mode based on the effect-site target concentration (Ce).

Other: Surgery commences in the morning.

Afternoon TCI group (AT)

The surgery start time was between 14：00 and 17:00, and the end time did not exceed 19:00. Patients in the TCI group underwent anesthetic induction and maintenance with ciprofol via target-controlled infusion (TCI) operated in Keo mode based on the effect-site target concentration (Ce).

Other: Surgery commences in the afternoon.

Morning non-TCI/Manual group (MC)

The surgery start time was between 08:00 and 11:00, and the end time did not exceed 13:00.Patients in the non-TCI group undergo anesthetic induction with ciprofol via manual bolus injection.

Other: Surgery commences in the morning.

Afternoon non-TCI/Manual group (AC)

The surgery start time was between 14：00 and 17:00, and the end time did not exceed 19:00.Patients in the non-TCI group undergo anesthetic induction with ciprofol via manual bolus injection.

Other: Surgery commences in the afternoon.

Interventions

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.

Morning TCI group (MT); Morning non-TCI/Manual group (MC)

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.

Afternoon TCI group (AT); Afternoon non-TCI/Manual group (AC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for surgical procedures under general anesthesia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jie Chen: lead
• Chongqing Medical University: collaborator
• People's Hospital of Chongqing Liangjiang New Area.: collaborator

Central Study Contacts

Jie Chen

CONTACT

00-86-023-13527517763; 305045@hospital.cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: July 7, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06