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

10. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

530

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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:

  • 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

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Aktiv komparator: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of intraoperative hypoxemia
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of intraoperative hypotension
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
induction time
Tidsramme: During anesthesia induction
Time from administration of the study drug to successful insertion of the endoscope
During anesthesia induction
Recovery time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ren Da

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)

10. juli 2026

Primær færdiggørelse (Anslået)

10. marts 2028

Studieafslutning (Anslået)

10. marts 2028

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BFHHZS20260216

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