Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07702240

Esketamine Versus Sufentanil for Sedation in Patients Undergoing 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Biliary Tract Diseases Agnosia Digestive System Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Procedural Sedation and Analgesia Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esketamine

Drug

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.

Sufentanil

Drug

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 outcomes

  1. 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.

    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.

Secondary outcomes

  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.

    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.

Other outcomes

  1. induction time

    Time frame: During anesthesia induction

    Time from administration of the study drug to successful insertion of the endoscope

  2. Recovery time

    Time frame: 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).

  3. Patient body movements

    Time frame: Throughout the procedure

    Number of patient body movements during the procedure requiring additional propofol administration or interfering with the procedure

  4. Endoscopist satisfaction

    Time frame: 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).

  5. Patient satisfaction

    Time frame: 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)

  6. Total propofol dose

    Time frame: 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

  7. Aldrete recovery score

    Time frame: 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

  8. Airway intervention

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tingting Fan, PhD

CONTACT

[email protected]

86+13439211460

Sponsors and collaborators

Lead sponsor

Ren Da

Other

Registry information

Official study title

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

Acronym: ES-ERCP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.