Biliary Tract Diseases, Procedural Sedation and Analgesia
Conditions
Keywords
Endoscopic Retrograde Cholangiopancreatography (ERCP), Procedural Sedation and Analgesia, Esketamine, Sufentanil, Propofol, Randomized Controlled Trial, Frail Patients
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.
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
DRUGEsketamine
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.
DRUGSufentanil
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.
Sponsors
Ren Da
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypoxemia | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Contacts
CONTACTTingting Fan, PhD
Outcome results
None listed