Determination of ED90 of Remimazolam Besylate Combined With Alfentanil for Gastroscopy Sedation in Obese Patients
NCT07925684, Not applicable, Recruiting, Jianbo Wu
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Determination of ED90 of Remimazolam Besylate Combined With Alfentanil for Gastroscopy Sedation in Obese Patients | ClinicalTrials.gov |
| NCT number | NCT07925684 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Jianbo Wu | ClinicalTrials.gov |
| Conditions | Procedural Sedation and Analgesia, Obesity & Overweight | ClinicalTrials.gov |
| Interventions | Alfentanil Hydrochloride Injection, Remimazolam Besylate for Injection | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The primary outcome is the ED90 (90% effective dose) of remimazolam besylate combined with alfentanil for suppressing the gastroscopic insertion response in obese patients. | From anesthesia induction to 1 minute after gastroscope insertion | The 90% effective dose (ED90) of remimazolam besylate combined with alfentanil to suppress gastroscopic insertion response in obese patients, estimated by biased coin sequential allocation design. Effective sedation (suppression of gastroscopic insertion response) is defined as MOAA/S score ≤ 1 within 3 minutes after remimazolam administration, without coughing, swallowing or body movement during gastroscope insertion and within 1 minute after insertion. Sedation failure is defined as failure to meet the above criteria. If the previous patient experiences sedation failure, the remimazolam dose for the next patient will be increased by 0.03 mg/kg. If the previous patient achieves effective sedation, the remimazolam dose for the next patient will maintain the same dose with an 89% probability or will be reduced by 0.03 mg/kg with an 11% probability according to the biased coin sequential allocation design. | ClinicalTrials.gov |
| Secondary | Changes in systolic blood pressure (SBP) | Periprocedural | Systolic blood pressure (SBP) is recorded at five predefined time points: T0 (baseline on entering the examination room), T1 (before gastroscope insertion), T2 (immediately after gastroscope insertion), T3 (the end of gastroscopy), T4 (at discharge from the Post-Anesthesia Care Unit (PACU)). | ClinicalTrials.gov |
| Secondary | Changes in diastolic blood pressure (DBP) | Periprocedural | Diastolic blood pressure (DBP) is recorded at five predefined time points: T0 (baseline on entering the examination room), T1 (before gastroscope insertion), T2 (immediately after gastroscope insertion), T3 (the end of gastroscopy), T4 (at discharge from the Post-Anesthesia Care Unit (PACU)). | ClinicalTrials.gov |
| Secondary | Changes in mean arterial pressure (MAP) | Periprocedural, including baseline and PACU discharge | Mean arterial pressure (MAP) is recorded at five predefined time points: T0 (baseline on entering the examination room), T1 (before gastroscope insertion), T2 (immediately after gastroscope insertion), T3 (the end of gastroscopy), T4 (at discharge from the Post-Anesthesia Care Unit (PACU)). | ClinicalTrials.gov |
| Secondary | Changes in heart rate (HR) | Periprocedural | Heart rate (HR) is recorded at five predefined time points: T0 (baseline on entering the examination room), T1 (before gastroscope insertion), T2 (immediately after gastroscope insertion), T3 (the end of gastroscopy), T4 (at discharge from the Post-Anesthesia Care Unit (PACU)). | ClinicalTrials.gov |
| Secondary | Changes in pulse oxygen saturation (SpO₂) | Periprocedural | Pulse oxygen saturation (SpO₂) is recorded at five predefined time points: T0 (baseline on entering the examination room), T1 (before gastroscope insertion), T2 (immediately after gastroscope insertion), T3 (the end of gastroscopy), T4 (at discharge from the Post-Anesthesia Care Unit (PACU)). | ClinicalTrials.gov |
| Secondary | Gastroscopy duration | Periprocedural | Gastroscopy duration is defined as the time period from gastroscope insertion to gastroscope withdrawal. | ClinicalTrials.gov |
| Secondary | Anesthesia induction time | Periprocedural | Anesthesia induction time is defined as the interval from the initiation of anesthesia induction to the time when the patient's Modified Observer's Assessment of Alertness/Sedation scale (MOAA/S) score ≤ 1. | ClinicalTrials.gov |
| Secondary | Incidence of adverse reactions | Periprocedural | Adverse reactions include hypotension (mean arterial pressure (MAP) decreased by more than 20% from baseline), hypoxemia, bradycardia (heart rate \< 50 beats per minute), hiccup and injection pain occurring during gastroscopy, as well as nausea and vomiting occurring during Post-Anesthesia Care Unit (PACU) stay. | ClinicalTrials.gov |
| Secondary | Satisfaction scores of participants, anesthesiologists and endoscopists | Periprocedural | Satisfaction is assessed by participants, anesthesiologists and endoscopists separately using a 10-point scale at Post-Anesthesia Care Unit (PACU) discharge after gastroscopy, with higher scores indicating greater satisfaction. | 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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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)