CompletedPhase 4

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

Croatia115 participantsStarted 2021-04-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * elective transurethral resection of bladder and prostate * American Society of Anesthesiologists (ASA) physical status classification system: I, II, III Exclusion Criteria: * regional anesthesia contraindications * American Society of Anesthesiologists (ASA) physical status classification system: IV * Atrioventricular cardiac block II and III degree * Psychotic disorders * Participants with tracheostomy * Dementia * Allergy on Dexmedetomidine or Midazolam

What they're measuring

Airway complications

Timeframe: During surgery

Coughing and restlessness

Timeframe: During surgery

Cardiorespiratory polygraphy

Timeframe: up to 30 weeks

Trial details

NCT IDNCT04817033

SponsorUniversity Hospital of Split

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-01

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