drugset / Trial / NCT06018207

ED50 of Midazolam Oral Solution for Preoperative Hypnosis in Adults : An Up-and-Down Sequential Allocation Trial

NCT06018207

NaSequentialOpen-labelTreatment

Summary

Due to sleep deficiency, patients with insomnia syndrome or sub-clinical insomnia syndrome often undergo severe stress while waiting for surgery. Studies have reported that preoperative hypnosis could reduce stress and promote recovery. Midazolam has been recommended to patients who under severe stress for preoperative sedation and anti-anxiety. However, midazolam for preoperative hypnosis monitored with polysomnography (PSG) has not been studied. In this exploratory study, the median effective dose (ED50) and ED95 of Midazolam Oral Solution for preoperative hypnosis in non-elderly adults using the gold standard tool of PSG, will be explored by up-and-down sequential allocation and probit method.

Timeline

Start
2023-09-05
Primary completion
2023-10-25
Completion
2023-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 5 mg Oral
Subject Midazolam Small molecule 6 mg Oral
Subject Midazolam Small molecule 7 mg Oral

Indications

No indication recorded.