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

NCT04817033 | Completed Phase 4

• 1 other identifier: 2181-147-01/06/M.S.-20-02
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Arterial blood pressure

  During surgery

• Symptomless Multi-Variable Apnea Prediction(sMVAP) index

  up to 30 weeks

• Medications

  During surgery

• Heart rate

  During surgery

• Cigarette smoking

  During surgery

Study Arms (4)

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

Procedure: Spinal anesthesia with intraoperative dexmedetomidine sedation; Drug: Dexmedetomidine

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

Procedure: Spinal anesthesia with intraoperative midazolam sedation; Drug: Midazolam

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

Procedure: Spinal anesthesia with intraoperative dexmedetomidine sedation; Drug: Dexmedetomidine

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

Procedure: Spinal anesthesia with intraoperative midazolam sedation; Drug: Midazolam

Interventions

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.

High risk OSA Dexmedetomidine; Low&Medium OSA Dexmedetomidine

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.

High risk OSA Midazolam; Low&Medium OSA Midazolam

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

Also known as: Dexmedetomidine sedation

High risk OSA Dexmedetomidine; Low&Medium OSA Dexmedetomidine

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

Also known as: Midazolam sedation

High risk OSA Midazolam; Low&Medium OSA Midazolam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective transurethral resection of bladder and prostate
• American Society of Anesthesiologists (ASA) physical status classification system: I, II, III

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

University Hospital Split

Split, 21000, Croatia

Location

Related Publications (10)

• 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.

  PMID: 29120932 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.

  PMID: 29300271 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.

  PMID: 28402089 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.

  PMID: 18431116 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.

  PMID: 25917473 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.

  PMID: 10969306 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.

  PMID: 8608068 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.

  PMID: 18005372 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.

  PMID: 30185146 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.

  PMID: 27366419 BACKGROUND

MeSH Terms

Conditions

Carnevale syndrome; Intraoperative Complications; Snoring; Airway Obstruction

Interventions

Anesthesia, Spinal; Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: factorial randomised controlled trial

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 25, 2021
• Study Start: April 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)