Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP (ES-ERCP)
10 de julho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
530
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Tingting Fan, PhD
- Número de telefone: 86+13439211460
- E-mail: fantt_aki@126.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of intraoperative hypoxemia
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of intraoperative hypotension
Prazo: 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.
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
induction time
Prazo: During anesthesia induction
|
Time from administration of the study drug to successful insertion of the endoscope
|
During anesthesia induction
|
|
Recovery time
Prazo: 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
Prazo: Throughout the procedure
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Number of patient body movements during the procedure requiring additional propofol administration or interfering with the procedure
|
Throughout the procedure
|
|
Endoscopist satisfaction
Prazo: 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
|
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Patient satisfaction
Prazo: Before discharge from the recovery room (PACU)
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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
Prazo: 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
Prazo: 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
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Upon arrival at the post-anesthesia care unit (PACU) and before discharge from PACU
|
|
Airway intervention
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
10 de julho de 2026
Conclusão Primária (Estimado)
10 de março de 2028
Conclusão do estudo (Estimado)
10 de março de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
3 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de julho de 2026
Primeira postagem (Real)
14 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Doenças do aparelho digestivo
- Manifestações Neurocomportamentais
- Distúrbios Perceptivos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Doenças das vias biliares
- Agnosia
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Piperidinas
- Fentanil
- Esketamina
- Sufentanil
Outros números de identificação do estudo
- BFHHZS20260216
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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