Finding ED90 of Flumazenil for Selective Improvement of Respiratory Distress by Remimazolam

NCT06563063 | Completed

• 1 other identifier: 4-2023-0507
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stomach Neoplasm

Keywords

Monitored anesthesia care; sedation; endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

• Whether it was successful or unsuccessful to improve the patient's respiratory distress

  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.

  30 seconds after the intervention

Study Arms (1)

Flumazenil

EXPERIMENTAL

Drug: Flumazenil

Interventions

Flumazenil DRUG

The dose determination for flumazenil followed a biased-coin up-and-down design. Starting with an initial dose of 5 mcg, if there was an improvement in respiratory distress, the biased-coin method was used to give the same dose in the next patient with a probability of 8/9, and a decreased dose of 5 mcg in the next patient with a probability of 1/9.

Flumazenil

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) class I-III
• years of age or older
• Scheduled for gastric ESD by MAC with remimazolam
• Hemodynamically stable patients.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Flumazenil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 20, 2024
• Study Start: August 23, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)