A 2×2 Factorial Randomized Controlled Trial for ERCP
7. mai 2026 oppdatert av: Gang Chen
Effects of Propofol Versus Ciprofol and Sufentanil Versus Es-ketamine on Intraoperative Desaturation and Hypotension in Elderly Patients Undergoing ERCP: A 2×2 Factorial Randomized Controlled Trial
To investigate the effects of propofol vs. cyclopropofol and sufentanil vs. esketamine on intraoperative hypoxemia and hypotension in elderly patients undergoing ERCP, as well as the interaction between these two factors.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Intervensjonell
Registrering (Antatt)
236
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Xiaocui Lv
- Telefonnummer: 13567109477
- E-post: 3412008@zju.edu.cn
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age ≥ 60 years old.
- ASA II-III level.
- BMI<30kg/m2.
- Patients who require elective therapeutic ERCP.
- Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of capacity, their guardian needs to act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.
Exclusion Criteria:
- Previous anatomical changes in the gastrointestinal tract, delayed gastric emptying, and gastric outlet obstruction.
- Coagulation dysfunction or tendency towards nosebleeds.
- Combined severe heart disease (coronary heart disease, myocardial infarction, congestive heart failure, left ventricular ejection fraction<40%, tachyarrhythmia)
- Have a history of allergies to relevant anesthetic drugs in the past.
- Severe pulmonary diseases (severe asthma attacks, respiratory failure, severe chronic obstructive pulmonary disease, severe interstitial lung disease, large pleural effusion, severe pulmonary arterial hypertension, etc.).
- Existing upper respiratory tract infection (within one week).
- Uncontrolled severe hypertension.
- Patients with increased intracranial pressure; Cerebral hemorrhage, intracranial space occupying lesions, acute phase of traumatic brain injury.
- Glaucoma and significant increase in intraocular pressure.
- Untreated or inadequately treated patients with hyperthyroidism.
- Serious liver and kidney diseases.
- Known neurological and psychiatric disorders (Parkinson's disease, epilepsy, or schizophrenia).
- Difficult airway: The anesthesiologist assessed the presence of difficult airway before surgery.
- Vulnerable groups other than the elderly/illiterate, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, etc.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Sham-komparator: propofol + sufentanil
|
Anesthesia induction using propofol+sufentanil
|
|
Aktiv komparator: propofol + esketamine
|
Anesthesia induction using propofol+esketamine
|
|
Aktiv komparator: ciprofol + sufentanil
|
Anesthesia induction using ciprofol+sufentanil
|
|
Eksperimentell: ciprofol + esketamine
|
Anesthesia induction using ciprofol+esketamine
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
hypoxemia
Tidsramme: perioperative
|
SpO2≤92%
|
perioperative
|
|
Hypotension
Tidsramme: Perioperative
|
blood pressure drop exceeding 20% of the baseline value, with mean arterial pressure ≤65 mmHg or systolic blood pressure ≤90 mmHg
|
Perioperative
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Severe hypoxemia
Tidsramme: Perioperative
|
75% ≤ SpO2<90%>60 s, SpO2<75%.
|
Perioperative
|
|
Hypotension/hypertension requiring the use of vasopressors.
Tidsramme: Perioperative
|
Hypotension/hypertension requiring the use of vasopressors.
|
Perioperative
|
|
Body movement.
Tidsramme: Perioperative
|
During ERCP, the patient's body movement affected the surgical procedure
|
Perioperative
|
|
Coughing
Tidsramme: Perioperative
|
During ERCP, the patient experienced coughing, which affected the surgical progress
|
Perioperative
|
|
Hiccup
Tidsramme: Perioperative
|
During ERCP, the patient experienced Hiccup, which affected the surgical progress。
|
Perioperative
|
|
Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation
Tidsramme: Perioperative
|
Need to urgently switch to endotracheal intubation or interrupt ERCP process due to airway operation
|
Perioperative
|
|
Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute).
Tidsramme: Perioperative
|
Tachycardia (HR>100 beats/minute) or bradycardia (HR<50 beats/minute).
|
Perioperative
|
|
The dosage of remifentanil used.
Tidsramme: Perioperative
|
The dosage of remifentanil used.
|
Perioperative
|
|
Recovery room time
Tidsramme: Perioperative
|
The time from removing the endoscope to reaching an Aldrete score of 10 in the endoscopic recovery room and leaving the room.
|
Perioperative
|
|
Postoperative recovery quality (QoR-15 scale score)
Tidsramme: The first day after surgery.
|
Use the QOR15 rating scale for scoring, with higher scores indicating better recovery quality
|
The first day after surgery.
|
|
Postoperative nausea and vomiting.
Tidsramme: postoperative
|
the incidence of postoperative nausea and vomiting.
|
postoperative
|
|
Patient satisfaction
Tidsramme: postoperative day 1
|
A 10 point visual analog scale was used to evaluate patient satisfaction with sedation types.
Among them, 1 represents the worst experience, and 10 represents the best experience.
The first day after ERCP, patients record their experience by checking the corresponding score on this scale.
|
postoperative day 1
|
|
Endoscope satisfaction
Tidsramme: postoperative Day 1
|
A 10 point visual analog scale was used to evaluate endoscope satisfaction with sedation types.
Among them, 1 represents the worst experience, and 10 represents the best experience.
|
postoperative Day 1
|
|
Hospitalization duration
Tidsramme: after discharge
|
The total length of hospital stay for the patient in this treatment
|
after discharge
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
27. april 2026
Primær fullføring (Antatt)
31. oktober 2026
Studiet fullført (Antatt)
31. oktober 2026
Datoer for studieregistrering
Først innsendt
24. mars 2026
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. mars 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ERCP for older patient
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .