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Not yet recruiting NCT07702240

Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP

No phase Interventional Biliary Tract Diseases Procedural Sedation and Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esketamine, Sufentanil.
Who it may be relevant to
Registry conditions: Biliary Tract Diseases, Procedural Sedation and Analgesia. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Incidence of intraoperative hypoxemia [Time frame: 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.]
Secondary outcome measures (1)
  • Incidence of intraoperative hypotension [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07702240 · BFHHZS20260216

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗