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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High risk OSA Dexmedetomidine | Active Comparator | High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate |
|
| High risk OSA Midazolam | Active Comparator | High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate |
|
| Low&Medium OSA Dexmedetomidine | Active Comparator | Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate |
|
| Low&Medium OSA Midazolam | Active Comparator | Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal anesthesia with intraoperative dexmedetomidine sedation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | During surgery |
| Cardiorespiratory polygraphy | OSA classification with apnea hypopnea index(AHI) for High risk OSA participants | up to 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial blood pressure | Systolic, diastolic and mean arterial blood pressure changes, Ephedrine use if systolic blood pressure < 100 mmHg or MAP<65 mmHg | During surgery |
| Symptomless Multi-Variable Apnea Prediction(sMVAP) index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Vukovic | University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia | Principal Investigator |
| Renata Pecotic | University of Split School of Medicine, Split, Croatia | Study Chair |
| Bozidar Duplancic | University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia | Study Chair |
| Benjamin Benzon | University of Split School of Medicine, Split, Croatia | Study Chair |
| Zoran Dogas | University of Split School of Medicine, Split, Croatia | Study Chair |
| Ruben Kovac | University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Split | Split | 21000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29120932 | Background | Madhusudan P, Wong J, Prasad A, Sadeghian E, Chung FF. An update on preoperative assessment and preparation of surgical patients with obstructive sleep apnea. Curr Opin Anaesthesiol. 2018 Feb;31(1):89-95. doi: 10.1097/ACO.0000000000000539. | |
| 29300271 | Background | Roesslein M, Chung F. Obstructive sleep apnoea in adults: peri-operative considerations: A narrative review. Eur J Anaesthesiol. 2018 Apr;35(4):245-255. doi: 10.1097/EJA.0000000000000765. |
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factorial randomised controlled trial
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|
| Spinal anesthesia with intraoperative midazolam sedation | Procedure | 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 | Drug | 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 | Drug | 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 |
|
|
OSA risk calculated by gender, age and BMI
| up to 30 weeks |
| Medications | Medications that participant use regularly | During surgery |
| Heart rate | Atropine 0.1 mg/kg use if pulse<50 | During surgery |
| Cigarette smoking | Participant is active cigarette smoker or nonsmoker | During surgery |
| ASA status | Participant ASA status | During surgery |
| Crystalloid infusion | Volume of crystalloid infusion at the end of surgery | During surgery |
| 28402089 | Background | Corso R, Russotto V, Gregoretti C, Cattano D. Perioperative management of obstructive sleep apnea: a systematic review. Minerva Anestesiol. 2018 Jan;84(1):81-93. doi: 10.23736/S0375-9393.17.11688-3. Epub 2017 Apr 11. |
| 18431116 | Background | Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4. |
| 25917473 | Background | Seet E, Chua M, Liaw CM. High STOP-BANG questionnaire scores predict intraoperative and early postoperative adverse events. Singapore Med J. 2015 Apr;56(4):212-6. doi: 10.11622/smedj.2015034. |
| 10969306 | Background | Pollock JE, Neal JM, Liu SS, Burkhead D, Polissar N. Sedation during spinal anesthesia. Anesthesiology. 2000 Sep;93(3):728-34. doi: 10.1097/00000542-200009000-00022. |
| 8608068 | Background | De Andres J, Valia JC, Gil A, Bolinches R. Predictors of patient satisfaction with regional anesthesia. Reg Anesth. 1995 Nov-Dec;20(6):498-505. |
| 18005372 | Background | Huupponen E, Maksimow A, Lapinlampi P, Sarkela M, Saastamoinen A, Snapir A, Scheinin H, Scheinin M, Merilainen P, Himanen SL, Jaaskelainen S. Electroencephalogram spindle activity during dexmedetomidine sedation and physiological sleep. Acta Anaesthesiol Scand. 2008 Feb;52(2):289-94. doi: 10.1111/j.1399-6576.2007.01537.x. Epub 2007 Nov 14. |
| 30185146 | Background | Shin HJ, Kim EY, Hwang JW, Do SH, Na HS. Comparison of upper airway patency in patients with mild obstructive sleep apnea during dexmedetomidine or propofol sedation: a prospective, randomized, controlled trial. BMC Anesthesiol. 2018 Sep 5;18(1):120. doi: 10.1186/s12871-018-0586-5. |
| 27366419 | Background | Mingir T, Ervatan Z, Turgut N. Spinal Anaesthesia and Perioperative Anxiety. Turk J Anaesthesiol Reanim. 2014 Aug;42(4):190-5. doi: 10.5152/TJAR.2014.99705. Epub 2014 May 29. |
| ID | Term |
|---|---|
| C535586 | Carnevale syndrome |
| D007431 | Intraoperative Complications |
| D012913 | Snoring |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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