Esketamine Versus Sufentanil for Sedation in Patients Undergoing ERCP
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRen Da
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Esketamine
DrugIntravenous 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.
Sufentanil
DrugIntravenous 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.
Treatment groups
530 Participants
are divided into 2 treatment groupsGroup A: Esketamine armExperimental treatment 1 intervention
Group B: Sufentanil armActive comparator 1 intervention
Trial outcomes
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.
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.Secondary outcomes
1
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.Other outcomes
1
induction time
Time from administration of the study drug to successful insertion of the endoscope
Time frame
During anesthesia induction2
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).
Time frame
From the end of the procedure to recovery from sedation3
Patient body movements
Number of patient body movements during the procedure requiring additional propofol administration or interfering with the procedure
Time frame
Throughout the procedure4
Endoscopist satisfaction
Endoscopist satisfaction with sedation conditions, assessed using a 10-point numeric rating scale (1 = extremely dissatisfied, 10 = extremely satisfied).
Time frame
Immediately after completion of the procedureLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ren Da
Lead sponsor
Beijing Friendship Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: