Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP (ES-ERCP)
10 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
530
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Tingting Fan, PhD
- Número de teléfono: 86+13439211460
- Correo electrónico: fantt_aki@126.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of intraoperative hypoxemia
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of intraoperative hypotension
Periodo de tiempo: 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.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
induction time
Periodo de tiempo: During anesthesia induction
|
Time from administration of the study drug to successful insertion of the endoscope
|
During anesthesia induction
|
|
Recovery time
Periodo de tiempo: 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
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Patient body movements
Periodo de tiempo: Throughout the procedure
|
Number of patient body movements during the procedure requiring additional propofol administration or interfering with the procedure
|
Throughout the procedure
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|
Endoscopist satisfaction
Periodo de tiempo: 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).
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Immediately after completion of the procedure
|
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Patient satisfaction
Periodo de tiempo: 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)
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Before discharge from the recovery room (PACU)
|
|
Total propofol dose
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Airway intervention
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
10 de julio de 2026
Finalización primaria (Estimado)
10 de marzo de 2028
Finalización del estudio (Estimado)
10 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
3 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2026
Publicado por primera vez (Actual)
14 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades del Sistema Digestivo
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedades del Tracto Biliar
- Agnosia
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Piperidinas
- Fentanilo
- Esketamina
- Sufentanilo
Otros números de identificación del estudio
- BFHHZS20260216
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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