A Phase 4 interventional study of Spinal anesthesia with intraoperative dexmedetomidine sedation and Spinal anesthesia with intraoperative midazolam sedation in Anesthesia, Anesthesia Complication and Osa Syndrome, sponsored by University Hospital of Split. Completed at 1 site in Croatia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by University Hospital of Split · Phase 4, Interventional, and Treatment
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.
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.
81 studies on the registry are indexed under Intraoperative Complications; 18 are open to participants now.
This study's enrollment of 115 is above the median of 66 across 41 interventional studies indexed under Intraoperative Complications.
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Exclusion Criteria:
High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate
Procedure: Spinal anesthesia with intraoperative dexmedetomidine sedation · Drug: Dexmedetomidine
High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate
Procedure: Spinal anesthesia with intraoperative midazolam sedation · Drug: Midazolam
Low\&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate
Procedure: Spinal anesthesia with intraoperative dexmedetomidine sedation · Drug: Dexmedetomidine
Low\&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate
Procedure: Spinal anesthesia with intraoperative midazolam sedation · Drug: Midazolam
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
Also known as: Dexmedetomidine sedation
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
Also known as: Midazolam sedation
Airway complications
Snoring detection, SpO2 and patient respiration monitoring, If SpO2 fell below 90% supplemental oxygen was delivered by facemask with reservoir bag at flow of 10 L/min. If oxygenation was still inadequate chin lift and jaw thrust maneuver were performed and oropharyngeal airway was inserted.
Time frame: During surgery
Coughing and restlessness
Participants have to be relaxed and calm during surgery and sedation. Theirs coughing and restlessness result in movement that is disturbing to surgeon because they could puncture bladder/prostate with resectoscope and cause perforation. So when surgeon complains about participants movement due to theirs coughing and restlessness investigators check that on list.
Time frame: During surgery
Cardiorespiratory polygraphy
OSA classification with apnea hypopnea index(AHI) for High risk OSA participants
Time frame: up to 30 weeks
Arterial blood pressure
Systolic, diastolic and mean arterial blood pressure changes, Ephedrine use if systolic blood pressure \< 100 mmHg or MAP\<65 mmHg
Time frame: During surgery
Symptomless Multi-Variable Apnea Prediction(sMVAP) index
OSA risk calculated by gender, age and BMI
Time frame: up to 30 weeks
Medications
Medications that participant use regularly
Time frame: During surgery
Heart rate
Atropine 0.1 mg/kg use if pulse\<50
Time frame: During surgery
Cigarette smoking
Participant is active cigarette smoker or nonsmoker
Time frame: During surgery
ASA status
Participant ASA status
Time frame: During surgery
Crystalloid infusion
Volume of crystalloid infusion at the end of surgery
Time frame: During surgery
Plan to share: No
Ran from Apr 2021 to primary completion in Jan 2022, 9 months.
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Studies of the drugs tested here: Dexmedetomidine · Midazolam
Intraoperative Complications →
University Hospital of Split