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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817033
• Other study ID #: 2181-147-01/06/M.S.-20-02
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2022
• Source: University Hospital of Split
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Anesthesia
• Anesthesia Complication
• Intraoperative Complications
• Osa Syndrome
• Sedation Complication
• Snoring
• Transurethral Resection of Prostate

Intervention

Procedure:
• Spinal anesthesia with intraoperative dexmedetomidine sedation
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 sedation
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.

Drug:
• Dexmedetomidine
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
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

Locations

Country	Name	City	State
Croatia	University Hospital Split	Split

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Split

Country where clinical trial is conducted

Croatia, 

References & Publications (10)

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. — View Citation

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. — View Citation

De Andrés J, Valía JC, Gil A, Bolinches R. Predictors of patient satisfaction with regional anesthesia. Reg Anesth. 1995 Nov-Dec;20(6):498-505. — View Citation

Huupponen E, Maksimow A, Lapinlampi P, Särkelä M, Saastamoinen A, Snapir A, Scheinin H, Scheinin M, Meriläinen P, Himanen SL, Jääskeläinen S. Electroencephalogram spindle activity during dexmedetomidine sedation and physiological sleep. Acta Anaesthesiol Scand. 2008 Feb;52(2):289-94. Epub 2007 Nov 14. — View Citation

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. Review. — View Citation

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. — View Citation

Pollock JE, Neal JM, Liu SS, Burkhead D, Polissar N. Sedation during spinal anesthesia. Anesthesiology. 2000 Sep;93(3):728-34. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cardiorespiratory polygraphy	OSA classification with apnea hypopnea index(AHI) for High risk OSA participants	up to 30 weeks
Secondary	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
Secondary	Symptomless Multi-Variable Apnea Prediction(sMVAP) index	OSA risk calculated by gender, age and BMI	up to 30 weeks
Secondary	Medications	Medications that participant use regularly	During surgery
Secondary	Heart rate	Atropine 0.1 mg/kg use if pulse<50	During surgery
Secondary	Cigarette smoking	Participant is active cigarette smoker or nonsmoker	During surgery
Secondary	ASA status	Participant ASA status	During surgery
Secondary	Crystalloid infusion	Volume of crystalloid infusion at the end of surgery	During surgery