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Published on: September 24, 2020
Determining ED90 of Flumazenil for Selective Respiratory Distress Improvement Using Remimazolam During Endoscopic
Hyun Il Kim1, Da Hyun Jung2, Sung Jin Lee1
1Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea.
Background:
Patients undergoing endoscopic submucosal dissection under monitored anesthesia care (MAC) with remimazolam may develop respiratory distress during the procedure. In these cases, low doses of flumazenil improved respiratory distress without completely reversing sedation, which is a novel phenomenon. This study aimed to explore the ED90 of flumazenil to selectively improve respiratory distress in patients with MAC treated with remimazolam.
Methods:
Flumazenil dose determination followed a biased-coin up-and-down design. Starting with a dose of 5 mcg, if respiratory distress improved, 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. Any improvement in respiratory distress within 30 s of flumazenil administration was recorded. After the procedure, patients were asked whether they had any memory recall during the procedure. Centered isotonic regression was used to determine the ED90 of flumazenil.
Results:
Sixty patients were included in the study. The estimated ED90 was 76.72 mcg (95% CI: 68.07-102.62). Memory recall occurred in two of thirteen patients (15%) near the ED90 dose range (75 mcg and 80 mcg). None of the patients developed major postoperative complications (bleeding, perforation, or aspiration) within the 2-day postoperative period.
Conclusions:
This study determined that the ED90 of flumazenil for effectively alleviating respiratory distress in patients undergoing MAC with remimazolam was 76.7 mcg, without reversing consciousness. These findings provide valuable guidance for the care of patients undergoing sedation.
Insights
Low doses of flumazenil effectively improved respiratory distress in patients receiving remimazolam during monitored anesthesia care (MAC). The study determined the effective dose (ED90) of flumazenil for this specific application.
Area of Science:
- Anesthesiology
- Pharmacology
Background:
- Patients undergoing endoscopic submucosal dissection under monitored anesthesia care (MAC) with remimazolam may experience respiratory distress.
- Low-dose flumazenil has shown potential to improve respiratory distress without fully reversing sedation in these cases.
Purpose of the Study:
- To determine the effective dose 90 (ED90) of flumazenil for selectively improving respiratory distress in patients receiving remimazolam for MAC.
Main Methods:
- A biased-coin up-and-down design was employed for flumazenil dose determination, starting at 5 mcg.
- Improvement in respiratory distress was recorded within 30 seconds of administration.
- Centered isotonic regression was used to estimate the ED90.
Main Results:
- The estimated ED90 of flumazenil was 76.72 mcg (95% CI: 68.07-102.62).
- Memory recall was infrequent (15%) in patients near the ED90 dose range.
- No major postoperative complications were observed within 2 days.
Conclusions:
- The ED90 of flumazenil for alleviating respiratory distress during remimazolam-induced MAC was determined to be 76.7 mcg.
- Flumazenil effectively improved respiratory distress without reversing consciousness.
- Findings offer guidance for managing sedation in patients undergoing MAC.
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