Effect of Circadian Rhythm on the Sedative Efficacy and Recovery Quality of Ciprofol General Anesthesia: A Multi-Center Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 主要终点
- Incidence of hypotension during the induction period
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Willing to participate and having provided signed informed consent.
排除标准
- •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.
结局指标
主要结局
Incidence of hypotension during the induction period
时间窗: 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.
次要结局
- 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.)
- Incidence of hypertension throughout anesthesia(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(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(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(From the time of discontinuation of anesthetic infusion until the time of tracheal tube removal, assessed up to 2 hours.)
- Bispectral Index(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.)
研究者
Jie Chen
Chief Physician
The Second Affiliated Hospital of Chongqing Medical University