A 2×2 Factorial Randomized Controlled Trial for ERCP
7. maj 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
236
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xiaocui Lv
- Telefonnummer: 13567109477
- E-mail: 3412008@zju.edu.cn
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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
|
|
Eksperimentel: ciprofol + esketamine
|
Anesthesia induction using ciprofol+esketamine
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
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Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
27. april 2026
Primær færdiggørelse (Anslået)
31. oktober 2026
Studieafslutning (Anslået)
31. oktober 2026
Datoer for studieregistrering
Først indsendt
24. marts 2026
Først indsendt, der opfyldte QC-kriterier
7. maj 2026
Først opslået (Faktiske)
13. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. maj 2026
Sidst verificeret
1. marts 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ERCP for older patient
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