CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 115 enrolled
Drug / intervention
Dexmedetomidine +3 moredrug
Likely dose
Midazolam 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04817033
NCT04817033Phase 4Completed
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Comparison of Intraoperative Complications in Patients With or Without High Risk for Obstructive Sleep Apnea During Sedation With Midazolam or Dexmedetomidine Within Transurethral Resections of Bladder and Prostate

University Hospital of Split·interventional·Posted Mar 25, 2021·Updated Apr 8, 2022

In Brief

A Phase 4 clinical trial evaluating Spinal anesthesia with intraoperative dexmedetomidine sedation, Spinal anesthesia with intraoperative midazolam sedation, and 2 other interventions for Anesthesia and 7 related conditions. Completed, enrolled 115 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia, Anesthesia Complication, Osa Syndrome, Transurethral Resection of Prostate, Sedation Complication, Intraoperative Complications, Snoring, Airway Obstruction
CountriesCroatia
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 25, 2021
Enrollment StartApr 1, 2021
Primary CompletionJan 1, 2022
Study CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.3 years ago

Interventions

Spinal anesthesia with intraoperative dexmedetomidine sedationprocedure

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.

Spinal anesthesia with intraoperative midazolam sedationprocedure

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.

Dexmedetomidinedrug

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

Midazolamdrug

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