Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP (ES-ERCP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biliary Tract Diseases; Procedural Sedation and Analgesia
• Intervention / Treatment: Drug: Esketamine; Drug: Sufentanil

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.

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tingting Fan, PhD; Phone Number: 86+13439211460; Email: fantt_aki@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypotension	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
induction time	Time from administration of the study drug to successful insertion of the endoscope	During anesthesia induction
Recovery time	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	Number of patient body movements during the procedure requiring additional propofol administration or interfering with the procedure	Throughout the procedure
Endoscopist satisfaction	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Ren Da

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): March 10, 2028
• Study Completion (Estimated): March 10, 2028

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Propofol; Sufentanil; Procedural Sedation and Analgesia; Esketamine; Endoscopic Retrograde Cholangiopancreatography (ERCP); Frail Patients
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Digestive System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Biliary Tract Diseases; Agnosia; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl; Esketamine; Sufentanil
• Other Study ID Numbers: BFHHZS20260216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No