Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
NCT07922291, Not applicable, Not yet recruiting, Van Training and Research Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography | ClinicalTrials.gov |
| NCT number | NCT07922291 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Van Training and Research Hospital | ClinicalTrials.gov |
| Conditions | Deep Sedation, Endoscopic Retrograde Cholangiopancreatography, Anesthesia Recovery Period | ClinicalTrials.gov |
| Interventions | BIS-Guided Propofol Titration, Standard Clinical Propofol Titration | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Total Propofol Consumption | From induction of sedation to the end of the ERCP procedure | Total amount of propofol (mg) administered during the endoscopic retrograde cholangiopancreatography (ERCP) procedure, including induction, infusion and additional boluses. | ClinicalTrials.gov |
| Secondary | Gastroenterologist Satisfaction | Immediately after the end of the ERCP procedure | Procedural comfort and satisfaction rated by the gastroenterologist, who is blinded to group allocation, on a 5-point Likert scale (1 = very poor, 5 = very good). | ClinicalTrials.gov |
| Secondary | Heart Rate | Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure | Heart rate (beats per minute) measured by standard electrocardiographic monitoring. | ClinicalTrials.gov |
| Secondary | Incidence of Sedation-Related Complications | From induction of sedation to the end of the ERCP procedure | Number of participants with hypoxia (peripheral oxygen saturation, SpO2 \< 90%), hypotension (mean arterial pressure \< 65 mmHg or \> 20% decrease from baseline) or bradycardia (heart rate \< 50 beats per minute) during the procedure. | ClinicalTrials.gov |
| Secondary | Number of Additional Propofol Boluses | From induction of sedation to the end of the ERCP procedure | Number of additional propofol bolus doses given for signs of inadequate sedation (gagging, swallowing, patient movement) during the procedure. | ClinicalTrials.gov |
| Secondary | Time to Discharge Readiness From the Post-Anesthesia Care Unit | From the end of the procedure, up to 2 hours | Time (minutes) from the end of the procedure until the patient meets post-anesthesia care unit (PACU) discharge criteria according to the Modified Aldrete Score. | ClinicalTrials.gov |
| Secondary | Need for Airway Intervention | From induction of sedation to the end of the ERCP procedure | Number of participants requiring any airway intervention during sedation, recorded by the highest level required: chin lift/jaw thrust, bag-mask ventilation, insertion of an oral/nasal airway or supraglottic device, or endotracheal intubation. | ClinicalTrials.gov |
| Secondary | Mean Arterial Pressure | Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure | Mean arterial pressure (millimeters of mercury, mmHg) measured by non-invasive blood pressure monitoring. | ClinicalTrials.gov |
| Secondary | Peripheral Oxygen Saturation | Periprocedural: before induction, after induction, at 5, 10 and 15 minutes of the procedure, and at the end of the procedure | Peripheral oxygen saturation (SpO2, percentage) measured by pulse oximetry. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)