Circadian RhythmNCT07686432
Effect of Circadian Rhythm on the Sedative Efficacy and Recovery Quality of Ciprofol General Anesthesia: A Multi-Center Observational Study
An observational study of Circadian Rhythm and Ciprofol, run by Jie Chen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Circadian Rhythm, Ciprofol, Hemodynamic Instability
- What is being tested?
- Surgery commences in the morning. and Surgery commences in the afternoon.
- Type of treatment
- Injection or infusion
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 8 Jun 2026to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for surgical procedures under general anesthesia.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
- Being tested
- Surgery commences in the morning., Surgery commences in the afternoon.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: 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. Receives: Other: Surgery commences in the afternoon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Incidence of mean arterial pressure decreasing by >30% from baseline during the induction period and lasting for ≥1 minute.
Measured: 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
Incidence of MAP staying below 65 mmHg for at least 1 minute throughout anesthetic maintenance
Measured: 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
Incidence of MAP reduction > 20% from baseline during the anesthetic maintenance period
Measured: 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
Incidence of MAP reduction > 30% from baseline during the anesthetic maintenance period
Measured: 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
Total administered dose of various vasoactive agents during the entire anesthetic period
Measured: 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
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.
Measured: 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.
Time to successful anesthetic induction
Time to loss of eyelash reflex following ciprofol administration
Measured: 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 emergence
Time from discontinuation of anesthesia to the patient's first eye opening
Measured: From the time of discontinuation of anesthetic infusion until the time of the patient's first eye opening, assessed up to 2 hours.
Time to extubation
Time from discontinuation of anesthesia to tracheal extubation
Measured: From the time of discontinuation of anesthetic infusion until the time of tracheal tube removal, assessed up to 2 hours.
Bispectral Index
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start8 Jun 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Chen
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Chongqing Liangjiang New Area., Chongqing Medical University
- Responsible party
- Sponsor-investigator, Jie Chen, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686432
- Sponsor's protocol ID
- 2026EC083
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Circadian Rhythm on the Sedative Efficacy and Recovery Quality of Ciprofol General Anesthesia: A Multi-Center Observational Study
- ClinicalTrials.gov ID
- NCT07686432
- Acronym / sponsor ID
- 2026EC083
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Jie ChenUniversity, hospital or other
- Collaborators
- People's Hospital of Chongqing Liangjiang New Area., Chongqing Medical University
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Morning TCI group (MT) | – | Other: Surgery commences in the morning.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). |
| Afternoon TCI group (AT) | – | Other: Surgery commences in the afternoon.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). |
| Morning non-TCI/Manual group (MC) | – | Other: Surgery commences in the morning.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. |
| Afternoon non-TCI/Manual group (AC) | – | Other: Surgery commences in the afternoon.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgical procedures under general anesthesia.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery commences in the morning.The morning group was defined as patients whose surgery commenced between 08:00 and 11:00 and concluded by 13:00. | Other | Morning TCI group (MT), Morning non-TCI/Manual group (MC) |
| Surgery commences in the afternoon.The afternoon group was defined as patients whose surgery commenced between 14:00 and 17:00 and concluded by 19:00. | Other | Afternoon TCI group (AT), Afternoon non-TCI/Manual group (AC) |
Primary outcome
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.
10 secondary outcomes
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 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 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 > 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.
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.
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.
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 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 to extubation
Time frame: From the time of discontinuation of anesthetic infusion until the time of tracheal tube removal, assessed up to 2 hours.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm and Ciprofol, run by Jie Chen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Chen (00-86-023-13527517763, 305045@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.