drugset / Trial / NCT04817033

Sedation Complications in Urology During Spinal Anesthesia With Dexmedetomidine or Midazolam Regarding OSA Risk

NCT04817033 ↗

Phase 4 Completed 115 enrolled University Hospital of Split
RandomizedFactorialDouble-blindTreatment

Summary

Light to moderate sedation is recommended during surgery with spinal anesthesia . This study is exploring which sedation drug is better, midazolam or dexmedetomidine for transurethral resection of bladder and prostate in patients with or without high risk for obstructive sleep apnea (OSA). Patients were divided in two groups regarding OSA risk, and each group received midazolam or dexmedetomidine for sedation. Investigators observed intraoperative complications of airway and factors that are disturbing surgeon(movement due to participants coughing and restlessness) because one could puncture bladder or prostate and cause perforation.

Timeline

Start
2021-04-01
Primary completion
2022-01-01
Completion
2022-02-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous
Comparator Midazolam Small molecule 0.25 mg/kg Intravenous