Sedation Complications in Urology During Spinal Anesthesia With Dexmedetomidine or Midazolam Regarding OSA Risk
Condition: Anesthesia; Anesthesia Complication; Osa Syndrome; Transurethral Resection of Prostate; Sedation Complication; Intraoperative Complications; Snoring; Airway Obstruction
MeSH terms: Airway Obstruction; Snoring; Intraoperative Complications
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      All participants were premedicated with diazepam 5mg 12 hours and 1 hour before surgery.
      Thromboprophylaxis (enoxaparin 4000-6000 IU) depending on the body weight was given at least
      12 hours before surgery.

      Participants were divided by STOP-BANG(Snoring history, Tired during the day, Observed stop
      breathing while sleep, High blood pressure, BMI more than 35 kg/m2, Age more than 50 years,
      Neck circumference more than 40 cm and male Gender) questionnaire into one of two groups:
      high OSA and low&medium OSA. Each group was then allocated by permuted block randomisation
      into midazolam or dexmedetomidine group. The randomisation list was obtained from R program.
      The group allocations were contained in closed envelope that were opened before surgery after
      the completed enrollment procedure.

      Participants got IV cannula with switch for continuous intravenous infusion in operating
      theatre. Non invasive monitoring (electrodes for ECG, blood pressure cuff and pulse oximeter)
      was placed before induction of spinal anesthesia. 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.
      Participants were then positioned in uniform lithotomy position and 9cm pillow was inserted.
      After sensory block, defined as the absence of pain at T10 dermatome, was induced by
      needle-tip test by the anaesthesiologist, the surgery was initiated.

      Time after subarachnoid block was T0 and sedation with midazolam or dexmedetomidine was
      started via continuous intravenous infusion. Midazolam was started with 0.25 mg/kg of ideal
      body mass, and dexmedetomidine with 0.5 ug/kg through 10 minutes. Every 10 minutes sedation
      level was observed with Ramsay sedation scale (RSS). Drug was titrated to achieve RSS of 4 or
      5 (closed eyes and patient exhibited brisk or sluggish response to light glabellar tap or
      loud auditory stimulus). Independent blinded doctor was assessing RSS level, vital parameters
      and signs of airway obstruction every 10 minutes. Every 10 minutes systolic, diastolic and
      mean arterial pressure(MAP) were noticed along with heart rate, oxygen saturation by pulse
      oximetry(SpO2), RSS level and adverse intraoperative events: snoring as sign of airway
      obstruction, cough and restlessness as disturbing factors to surgeon. If peripheral oxygen
      fell below 90% supplemental oxygen was delivered by facemask with reservoir bag at flow of 10
      L/min. End tidal carbon dioxide(CO2)was measured for detection of possible apnea. If
      oxygenation was still inadequate chin lift and jaw thrust maneuver were performed and
      oropharyngeal airway was inserted if needed. If heart rate fell below 50 bpm atropine 0.1
      mg/kg was given and if systolic blood pressure fell below 100 mmHg(or MAP < 65 mmHg)
      ephedrine 5mg bolus was given. Total crystalloid infusion volume was noticed at the end of
      surgery. All measurements were performed every 10 minutes and 1 hour after surgery in urology
      intensive care. High risk OSA participants underwent cardiorespiratory polygraphy at Center
      for sleep medicine Split.
    

Intervention name(s): Spinal anesthesia with intraoperative dexmedetomidine sedation; Spinal anesthesia with intraoperative midazolam sedation; Dexmedetomidine; Midazolam
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): 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.; 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.; 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; 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
Other intervention name(s): Dexmedetomidine sedation; Midazolam sedation
Intervention MeSH terms: Midazolam; Dexmedetomidine; Anesthetics
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: factorial randomised controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Midazolam; STOP BANG questionnaire; Intraoperative complications; Spinal anesthesia; Cardiorespiratory polygraphy; sMVAP index; Sedation