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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingting Fan, PhD | Contact | 86+13439211460 | fantt_aki@126.com |
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| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
|
| 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. |
|
| 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 |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |