Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP (ES-ERCP)
10 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
530
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Tingting Fan, PhD
- Numéro de téléphone: 86+13439211460
- E-mail: fantt_aki@126.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of intraoperative hypoxemia
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of intraoperative hypotension
Délai: 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.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
induction time
Délai: During anesthesia induction
|
Time from administration of the study drug to successful insertion of the endoscope
|
During anesthesia induction
|
|
Recovery time
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
10 juillet 2026
Achèvement primaire (Estimé)
10 mars 2028
Achèvement de l'étude (Estimé)
10 mars 2028
Dates d'inscription aux études
Première soumission
3 juillet 2026
Première soumission répondant aux critères de contrôle qualité
10 juillet 2026
Première publication (Réel)
14 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Maladies du système digestif
- Manifestations neurocomportementales
- Troubles de la perception
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Maladies des voies biliaires
- Agnosie
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Pipéridines
- Fentanyl
- Eskétamine
- Sufentanil
Autres numéros d'identification d'étude
- BFHHZS20260216
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .