Clinical trial · Interventional
Finding ED90 of Flumazenil for Selective Improvement of Respiratory Distress by Remimazolam
Exploring the ED90 Capacity of Plumazenyl for the Improvement of Respiratory Deterioration During Anesthesia Management Under Monitoring Using Remimazolam - Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients undergoing endoscopic submucosal dissection with monitored anesthesia care (MAC) using remimazolam may develop respiratory distress during the procedure. In these cases, substandard doses of flumazenil have been found to improve respiratory distress without completely reversing sedation, a novel and previously unknown phenomenon. This study aimed to explore the ED90 of flumazenil to selectively improve only respiratory distress during MAC with remimazolam. The dose determination for flumazenil will follow a biased-coin up-and-down design. Starting with an initial dose of 5 mcg, if there is an improvement in respiratory distress, the biased-coin method will be used to administer the same dose to the next patient with a probability of 8/9, and a decreased dose of 5 mcg to the next patient with a probability of 1/9. Any improvement in respiratory distress within 30 seconds of flumazenil administration will be recorded. After the procedure, the patient will be asked if they had any memory recall of the procedure. Centered isotonic regression will be used to obtain the ED90 of flumazenil.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasm | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flumazenil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Flumazenil
- interventionNames
- Drug: Flumazenil
Primary outcomes (1)
- measure
- Whether it was successful or unsuccessful to improve the patient's respiratory distress
- timeFrame
- 30 seconds after the intervention
- description
- Respiratory distress occurring during the procedure were defined as follows: 1) sustained hypoxia (SpO2 \< 94%); or 2) excessive irregular breathing with heavy chest and abdominal movement, making it impossible for the endoscopist to perform the procedure. Improvement in respiratory distress was defined as recovery of hypoxia (SpO2 ≥ 95%) and improvement in respiratory pattern-loss of excessively irregular breathing and subdued chest and abdominal movement-within 30 seconds after flumazenil administration to the extent that the procedure could be resumed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * American Society of Anesthesiologists (ASA) class I-III * 19 years of age or older * Scheduled for gastric ESD by MAC with remimazolam * Hemodynamically stable patients. Exclusion Criteria: * Patients who have airway-related anatomic abnormalities * Being requested by the endoscopist to be fully awake from anesthesia for any reason other than respiroatyr distress during the procedure * Being administered any sedative other than remimazolam during the procedure (e.g., propofol, dexmedetomidine, etc.)
References
Publications (0)
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