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

Primary Purpose

Anesthesia, Anesthesia Complication, Osa Syndrome

Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Spinal anesthesia with intraoperative dexmedetomidine sedation
Spinal anesthesia with intraoperative midazolam sedation
Dexmedetomidine
Midazolam
Sponsored by
University Hospital of Split
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Dexmedetomidine, Midazolam, STOP BANG questionnaire, Intraoperative complications, Spinal anesthesia, Cardiorespiratory polygraphy, sMVAP index, Sedation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Split

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

High risk OSA Dexmedetomidine

High risk OSA Midazolam

Low&Medium OSA Dexmedetomidine

Low&Medium OSA Midazolam

Arm Description

High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate

Outcomes

Primary Outcome Measures

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.
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.
Cardiorespiratory polygraphy
OSA classification with apnea hypopnea index(AHI) for High risk OSA participants

Secondary Outcome Measures

Arterial blood pressure
Systolic, diastolic and mean arterial blood pressure changes, Ephedrine use if systolic blood pressure < 100 mmHg or MAP<65 mmHg
Symptomless Multi-Variable Apnea Prediction(sMVAP) index
OSA risk calculated by gender, age and BMI
Medications
Medications that participant use regularly
Heart rate
Atropine 0.1 mg/kg use if pulse<50
Cigarette smoking
Participant is active cigarette smoker or nonsmoker
ASA status
Participant ASA status
Crystalloid infusion
Volume of crystalloid infusion at the end of surgery

Full Information

First Posted
March 18, 2021
Last Updated
April 7, 2022
Sponsor
University Hospital of Split
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1. Study Identification

Unique Protocol Identification Number
NCT04817033
Brief Title
Sedation Complications in Urology During Spinal Anesthesia With Dexmedetomidine or Midazolam Regarding OSA Risk
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Split

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Anesthesia Complication, Osa Syndrome, Transurethral Resection of Prostate, Sedation Complication, Intraoperative Complications, Snoring, Airway Obstruction
Keywords
Dexmedetomidine, Midazolam, STOP BANG questionnaire, Intraoperative complications, Spinal anesthesia, Cardiorespiratory polygraphy, sMVAP index, Sedation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Model Description
factorial randomised controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High risk OSA Dexmedetomidine
Arm Type
Active Comparator
Arm Description
High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate
Arm Title
High risk OSA Midazolam
Arm Type
Active Comparator
Arm Description
High risk OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate
Arm Title
Low&Medium OSA Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate
Arm Title
Low&Medium OSA Midazolam
Arm Type
Active Comparator
Arm Description
Low&Medium OSA defined by STOP BANG questionnaire Intraoperative sedation during spinal anesthesia for transurethral resection of bladder and prostate
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia with intraoperative dexmedetomidine sedation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia with intraoperative midazolam sedation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine sedation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Midazolam sedation
Intervention Description
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
Primary Outcome Measure Information:
Title
Airway complications
Description
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
Title
Coughing and restlessness
Description
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
Title
Cardiorespiratory polygraphy
Description
OSA classification with apnea hypopnea index(AHI) for High risk OSA participants
Time Frame
up to 30 weeks
Secondary Outcome Measure Information:
Title
Arterial blood pressure
Description
Systolic, diastolic and mean arterial blood pressure changes, Ephedrine use if systolic blood pressure < 100 mmHg or MAP<65 mmHg
Time Frame
During surgery
Title
Symptomless Multi-Variable Apnea Prediction(sMVAP) index
Description
OSA risk calculated by gender, age and BMI
Time Frame
up to 30 weeks
Title
Medications
Description
Medications that participant use regularly
Time Frame
During surgery
Title
Heart rate
Description
Atropine 0.1 mg/kg use if pulse<50
Time Frame
During surgery
Title
Cigarette smoking
Description
Participant is active cigarette smoker or nonsmoker
Time Frame
During surgery
Title
ASA status
Description
Participant ASA status
Time Frame
During surgery
Title
Crystalloid infusion
Description
Volume of crystalloid infusion at the end of surgery
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Vukovic
Organizational Affiliation
University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renata Pecotic
Organizational Affiliation
University of Split School of Medicine, Split, Croatia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bozidar Duplancic
Organizational Affiliation
University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Benjamin Benzon
Organizational Affiliation
University of Split School of Medicine, Split, Croatia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Zoran Dogas
Organizational Affiliation
University of Split School of Medicine, Split, Croatia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ruben Kovac
Organizational Affiliation
University Hospital Split, Department of Anesthesiology and Intensive Care, Split, Croatia
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Split
City
Split
ZIP/Postal Code
21000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29120932
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.
Results Reference
background
PubMed Identifier
29300271
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.
Results Reference
background
PubMed Identifier
28402089
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.
Results Reference
background
PubMed Identifier
18431116
Citation
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.
Results Reference
background
PubMed Identifier
25917473
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. doi: 10.11622/smedj.2015034.
Results Reference
background
PubMed Identifier
10969306
Citation
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.
Results Reference
background
PubMed Identifier
8608068
Citation
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.
Results Reference
background
PubMed Identifier
18005372
Citation
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.
Results Reference
background
PubMed Identifier
30185146
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.
Results Reference
background
PubMed Identifier
27366419
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.
Results Reference
background

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

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