Effect of Circadian Rhythm on the Sedative Efficacy and Recovery Quality of Ciprofol General Anesthesia: A Multi-Center Observational Study
29 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
480
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jie Chen
- Numéro de téléphone: 00-86-023-13527517763
- E-mail: 305045@hospital.cqmu.edu.cn
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Patients scheduled for surgical procedures under general anesthesia.
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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). |
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). |
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.
|
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.
|
The afternoon group was defined as patients whose surgery commenced between 14:00 and 17:00 and concluded by 19:00.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of hypotension during the induction period
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of mean arterial pressure decreasing by >30% from baseline during the induction period and lasting for ≥1 minute.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
8 juin 2026
Achèvement primaire (Estimé)
30 mai 2027
Achèvement de l'étude (Estimé)
30 mai 2027
Dates d'inscription aux études
Première soumission
1 juin 2026
Première soumission répondant aux critères de contrôle qualité
29 juin 2026
Première publication (Réel)
7 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2026EC083
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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