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

PHASE4CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

January 1, 2022

Study Completion Date

February 1, 2022

Conditions
AnesthesiaAnesthesia ComplicationOsa SyndromeTransurethral Resection of ProstateSedation ComplicationIntraoperative ComplicationsSnoringAirway Obstruction
Interventions
PROCEDURE

Spinal anesthesia with intraoperative dexmedetomidine sedation

Skin was disinfected and 40mg of 2% Lidocaine was given subcutaneously at lumbar vertebrae 3/4 level. 25 G spinal needle was used and after dura and arachnoidea were pierced 12.5-15 mg of 0.5% Levobupivacaine was applied.

PROCEDURE

Spinal anesthesia with intraoperative midazolam sedation

Skin was disinfected and 40mg of 2% Lidocaine was given subcutaneously at lumbar vertebrae 3/4 level. 25 G spinal needle was used and after dura and arachnoidea were pierced 12.5-15 mg of 0.5% Levobupivacaine was applied.

DRUG

Dexmedetomidine

Dexmedetomidine 0.5 ug/kg during first 10 minutes after successful spinal anesthesia. Dose maintained to keep patient in moderate sedation with closed eyes and Ramsay sedation scale 4 and 5 level

DRUG

Midazolam

Midazolam 0.25 mg/kg ideal body weight during first 10 minutes after successful spinal anesthesia. Dose maintained to keep patient in moderate sedation with closed eyes and Ramsay sedation scale 4 and 5 level

Trial Locations (1)

21000

University Hospital Split, Split

All Listed Sponsors
lead

University Hospital of Split

OTHER

NCT04817033 - Sedation Complications in Urology During Spinal Anesthesia With Dexmedetomidine or Midazolam Regarding OSA Risk | Biotech Hunter | Biotech Hunter