Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP (ES-ERCP)
10 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
530
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Tingting Fan, PhD
- Numero di telefono: 86+13439211460
- Email: fantt_aki@126.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of intraoperative hypoxemia
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of intraoperative hypotension
Lasso di tempo: 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.
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
induction time
Lasso di tempo: During anesthesia induction
|
Time from administration of the study drug to successful insertion of the endoscope
|
During anesthesia induction
|
|
Recovery time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
10 luglio 2026
Completamento primario (Stimato)
10 marzo 2028
Completamento dello studio (Stimato)
10 marzo 2028
Date di iscrizione allo studio
Primo inviato
3 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2026
Primo Inserito (Effettivo)
14 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Malattie dell'apparato digerente
- Manifestazioni neurocomportamentali
- Disturbi percettivi
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Malattie delle vie biliari
- Agnosi
- Composti eterociclici, 1-anello
- Composti eterociclici
- Piperidine
- Fentanil
- Esketamina
- Sufentanil
Altri numeri di identificazione dello studio
- BFHHZS20260216
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .