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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
530
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.
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.
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.
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.
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.
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.
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