Trial · NCT05437497
Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy
NCT05437497, Not applicable, Unknown, The Third Xiangya Hospital of Central South University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy. Trials, record NCT05437497. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05437497
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Evaluation of Remimazolam for Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy
- NCT number
- NCT05437497
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 264 participants, estimated
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Conditions
- Endoscopic Ultrasonography-guided Fine Needle Aspiration, Sedation Complication, Remimazolam
- Interventions
- Remimazolam Injection, Propofol Injection
- First posted
- 2022-06-29
- Last updated
- 2022-06-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cardiopulmonary adverse event incidence | The whole EUS-FNA/FNB procedure | The occurrence of any one of the following reactions was recorded as "Cardiopulmonary Adverse Event", and the cardiopulmonary adverse event incidence was defined as the proportion of the subjects with cardiopulmonary adverse events in each group. Cardiopulmonary adverse events were defined as: any of the following conditions occurred during the operation: 1. respiratory depression: oxygen saturation \<90%, or breathing \<8 times/min; 2. apnea: respiratory airflow stopped for more than 15s; 3. hypotension: systolic blood pressure decrease greater than 20% of baseline systolic blood pressure; 4. hypertension: systolic blood pressure increase greater than 20% of baseline systolic blood pressure; 5. tachycardia: heart rate\>100bpm for 1 minute or more; 6. bradycardia: HR\<50, lasting 1 minute or more |
| Secondary | Adverse event incidence | The whole EUS-FNA/FNB procedure | The respective incidence of each adverse event that occurred during the EUS-FNA/FNB procedure, such as the incidence of cough or body movement. |
| Secondary | Sedation success rate: | The whole EUS-FNA/FNB procedure | Sedation success was defined as: completion of the entire procedure; no sedative rescue medication administered; ≤5 additional doses in any 15-minute period from the end of the initial dose of the trial drug. The sedation success rate was defined as the proportion of subjects in the group who were successfully sedated. |
| Other | Dosage of sedations | The whole EUS-FNA/FNB procedure | The total dosage of remimazolam or propofol and the dosage per kilogram of body weight. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05437497
GET https://conductscience.org/api/trials/v1/NCT05437497/registered