Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP

Официальное название

Effects of Esketamine-Propofol Versus Sufentanil-Propofol Sedation on Hypoxemia and Hypotension During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Incidence of intraoperative hypoxemia [Срок оценки: 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.]

Вторичные конечные точки (1)

• Incidence of intraoperative hypotension [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07702240 · BFHHZS20260216

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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