Effect of Circadian Rhythm on the Sedative Efficacy and Recovery Quality of Ciprofol General Anesthesia: A Multi-Center Observational Study
29 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
480
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jie Chen
- Numero di telefono: 00-86-023-13527517763
- Email: 305045@hospital.cqmu.edu.cn
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione di probabilità
Popolazione di studio
Patients scheduled for surgical procedures under general anesthesia.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of hypotension during the induction period
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of mean arterial pressure decreasing by >30% from baseline during the induction period and lasting for ≥1 minute.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
8 giugno 2026
Completamento primario (Stimato)
30 maggio 2027
Completamento dello studio (Stimato)
30 maggio 2027
Date di iscrizione allo studio
Primo inviato
1 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 giugno 2026
Primo Inserito (Effettivo)
7 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2026EC083
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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