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Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP (ES-ERCP)

10 juli 2026 bijgewerkt door: Ren Da

Effects of Esketamine-Propofol Versus Sufentanil-Propofol Sedation on Hypoxemia and Hypotension During Endoscopic Retrograde Cholangiopancreatography (ERCP)

This study compares two anesthesia medications, esketamine and sufentanil, used together with propofol during ERCP procedures. The goal is to find out which combination provides better safety and comfort for people undergoing ERCP.

Participants will be randomly assigned to receive either esketamine or sufentanil during sedation. Researchers will monitor blood oxygen levels, blood pressure, and recovery time during and after the procedure to evaluate safety and effectiveness.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This randomized controlled trial compares the effects of intravenous esketamine and intravenous sufentanil as adjuncts to propofol sedation in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).

The study aims to evaluate differences in intraoperative hemodynamic stability, oxygenation, sedation quality, and recovery profiles between the two sedation strategies.

Participants will be randomly assigned to receive either esketamine or sufentanil in combination with propofol during the ERCP procedure. Sedation will be titrated to achieve an adequate level of sedation based on clinical assessment.

Standard monitoring will be applied throughout the procedure, including continuous pulse oximetry and non-invasive blood pressure measurement at predefined time points. Hemodynamic instability, including hypotension and oxygen desaturation, will be managed according to predefined clinical protocols.

Adverse events will be recorded throughout the perioperative period and assessed for severity and relatedness to the study interventions.

The study is designed to reflect routine clinical anesthesia practice while systematically comparing two commonly used adjunct analgesic strategies for procedural sedation in ERCP patients.

Studietype

Ingrijpend

Inschrijving (Geschat)

530

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Adults aged ≥18 years
  • Patients scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP)
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body mass index (BMI) between 18.5 and 30 kg/m²
  • Patients requiring sedation for ERCP
  • Ability to provide written informed consent voluntarily

Exclusion Criteria:

  • Allergy or contraindication to propofol, esketamine, sufentanil, or related medications
  • Severe hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
  • Severe dysfunction of the heart, lungs, liver, or kidneys
  • History of central nervous system disorders or psychiatric disorders
  • Anticipated difficult airway
  • History of psychiatric disorders or contraindications to ketamine use
  • Inability to communicate or provide informed consent
  • Requirement for general anesthesia with endotracheal intubation or intraoperative conversion to general anesthesia with intubation

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Esketamine arm
Participants receive intravenous esketamine in combination with propofol for procedural sedation during ERCP. Esketamine is administered as an adjunct analgesic during induction of sedation, while propofol is continuously infused and titrated according to clinical sedation requirements.
Geneesmiddel: Esketamine
Intravenous esketamine is administered as an adjunct analgesic during induction of sedation for ERCP. It is used in combination with continuously infused propofol, with dosing titrated to achieve adequate procedural sedation. This regimen differs from the comparator arm in that esketamine is used as the primary analgesic agent instead of an opioid.
Actieve vergelijker: Sufentanil arm
Participants receive intravenous sufentanil in combination with propofol for procedural sedation during ERCP. Sufentanil is administered as an adjunct analgesic during induction of sedation, while propofol is continuously infused and titrated according to clinical sedation requirements.
Geneesmiddel: Sufentanil
Intravenous sufentanil is administered as an adjunct analgesic during induction of sedation for ERCP. It is used in combination with continuously infused propofol, with dosing titrated to achieve adequate procedural sedation. This regimen differs from the comparator arm in that sufentanil is used as the opioid-based analgesic instead of esketamine.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of intraoperative hypoxemia
Tijdsspanne: Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.
Hypoxemia is defined as peripheral oxygen saturation (SpO₂) < 90% lasting ≥ 10 seconds. Peripheral oxygen saturation (SpO₂) were recorded at six predefined time points: T0, T1, T2, T3, T4, T5.
Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of intraoperative hypotension
Tijdsspanne: Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.
Hypotension was defined as a reduction in mean arterial pressure (MAP) of ≥30% from baseline or a systolic arterial pressure (SAP) <90 mmHg. Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP) were recorded at six predefined time points: T0, T1, T2, T3, T4, T5.
Six time points:T0, upon arrival in the procedure room (baseline); T1, after anesthesia induction; T2, when the endoscope passed the vocal cords; T3, when the endoscope passed the duodenal papilla; T4, at the end of the procedure; and T5, upon recovery.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
induction time
Tijdsspanne: During anesthesia induction
Time from administration of the study drug to successful insertion of the endoscope
During anesthesia induction
Recovery time
Tijdsspanne: From the end of the procedure to recovery from sedation
Time from discontinuation of propofol administration to recovery of consciousness, defined as achieving an Observer's Assessment of Alertness/Sedation (OAA/S) score of 5. The score ranges from 1 to 5, with higher scores indicating a higher level of alertness. Recovery was defined as achieving an OAA/S score of 5 (responds readily to name spoken in a normal tone).
From the end of the procedure to recovery from sedation
Patient body movements
Tijdsspanne: Throughout the procedure
Number of patient body movements during the procedure requiring additional propofol administration or interfering with the procedure
Throughout the procedure
Endoscopist satisfaction
Tijdsspanne: Immediately after completion of the procedure
Endoscopist satisfaction with sedation conditions, assessed using a 10-point numeric rating scale (1 = extremely dissatisfied, 10 = extremely satisfied).
Immediately after completion of the procedure
Patient satisfaction
Tijdsspanne: Before discharge from the recovery room (PACU)
Patient satisfaction with the anesthesia experience, assessed using a 10-point numeric rating scale (1 = extremely dissatisfied, 10 = extremely satisfied)
Before discharge from the recovery room (PACU)
Total propofol dose
Tijdsspanne: From induction of sedation to the end of the procedure
The total amount of propofol administered during the procedure, including the induction dose and additional doses required to maintain adequate sedation
From induction of sedation to the end of the procedure
Aldrete recovery score
Tijdsspanne: Upon arrival at the post-anesthesia care unit (PACU) and before discharge from PACU
Recovery from sedation was assessed using the modified Aldrete recovery score, which evaluates activity, respiration, circulation, consciousness, and oxygen saturation. The score ranges from 0 to 10, with higher scores indicating better recovery
Upon arrival at the post-anesthesia care unit (PACU) and before discharge from PACU
Airway intervention
Tijdsspanne: From induction of sedation to the end of the procedure
The need for airway interventions to manage sedation-related respiratory compromise, including chin lift, jaw thrust, oral airway insertion, or mask ventilation during the procedure
From induction of sedation to the end of the procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ren Da

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 juli 2026

Primaire voltooiing (Geschat)

10 maart 2028

Studie voltooiing (Geschat)

10 maart 2028

Studieregistratiedata

Eerst ingediend

3 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BFHHZS20260216

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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