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

29. června 2026 aktualizováno: Jie Chen

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

480

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

Patients scheduled for surgical procedures under general anesthesia.

Popis

Inclusion Criteria:

  1. Aged 18-65 years, with ASA physical status I-II.
  2. Body Mass Index (BMI) between 18-30 kg/m².
  3. Scheduled for elective non-cardiac and non-intracranial surgery under general anesthesia, with an expected operative duration of 1-2 hours.
  4. 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.
  5. Willing to participate and having provided signed informed consent.

Exclusion Criteria:

  1. Severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR < 30 ml/min/1.73m²).
  2. Severe cardiovascular, respiratory, or neurological diseases.
  3. Long-term use of sedative-hypnotics, anxiolytics, antidepressants, or glucocorticoids.
  4. Known allergy to ciprofol, propofol, or their excipients.
  5. Recent (within 3 months) history of shift work, transmeridian travel, or other conditions that may cause circadian rhythm disruption.
  6. Pregnant or lactating women.
  7. Any other condition deemed by the investigator as unsuitable for participation in this study.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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).
Jiný: 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.
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).
Jiný: 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.
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.
Jiný: 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.
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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of hypotension during the induction period
Časové okno: 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.
From the time of initial anesthetic drug administration until 5 minutes after completion of tracheal intubation (maximum duration limited to 20 minutes)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of mean arterial pressure decreasing by >30% from baseline during the induction period and lasting for ≥1 minute.
Časové okno: 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.
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
Časové okno: 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
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
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
Časové okno: 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.
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
Časové okno: 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
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
Časové okno: 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
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
Časové okno: 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
From the time of discontinuation of anesthetic infusion until the time of tracheal tube removal, assessed up to 2 hours.
Bispectral Index
Časové okno: 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.
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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Jie Chen

Spolupracovníci

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

8. června 2026

Primární dokončení (Odhadovaný)

30. května 2027

Dokončení studie (Odhadovaný)

30. května 2027

Termíny zápisu do studia

První předloženo

1. června 2026

První předloženo, které splnilo kritéria kontroly kvality

29. června 2026

První zveřejněno (Aktuální)

7. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2026EC083

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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