Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP

NCT07702240 | Not Yet Recruiting

• 1 other identifier: BFHHZS20260216
• Study Type: interventional
• Target: 530
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Biliary Tract Diseases; Procedural Sedation and Analgesia

Keywords

Endoscopic Retrograde Cholangiopancreatography (ERCP); Procedural Sedation and Analgesia; Esketamine; Sufentanil; Propofol; Randomized Controlled Trial; Frail Patients

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative hypoxemia

  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.

Secondary Outcomes (1)

• Incidence of intraoperative hypotension

  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.

Other Outcomes (8)

• induction time

  During anesthesia induction

• Recovery time

  From the end of the procedure to recovery from sedation

• Patient body movements

  Throughout the procedure

Study Arms (2)

Esketamine arm

EXPERIMENTAL

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.

Drug: Esketamine

Sufentanil arm

ACTIVE COMPARATOR

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.

Drug: Sufentanil

Interventions

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.

Esketamine arm

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.

Sufentanil arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ren Da: lead

MeSH Terms

Conditions

Biliary Tract Diseases; Agnosia

Interventions

Esketamine; Sufentanil

Condition Hierarchy (Ancestors)

Digestive System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Tingting Fan, PhD

CONTACT

86+13439211460; fantt_aki@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to pharmacodynamic differences between study drugs, the anesthesiologist may infer treatment allocation based on patients' physiological responses; therefore, strict double-blinding is not feasible in this study. To minimize potential bias, allocation concealment and assessor blinding are implemented. Outcome data are collected and evaluated by study personnel who are not involved in anesthesia administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 14, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): March 10, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share