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| Name | Class |
|---|---|
| People's Hospital of Chongqing Liangjiang New Area. | UNKNOWN |
| Chongqing Medical University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the time of initial anesthetic drug administration until 5 minutes after completion of tracheal intubation (maximum duration limited to 20 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for surgical procedures under general anesthesia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Chen | Contact | 00-86-023-13527517763 | 305045@hospital.cqmu.edu.cn |
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| 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. |
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| 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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. | 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. |