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Influence of Different Anesthetic Procedures on Sleep Disorder Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499132
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic

Brief Summary:
Obstructive sleep apnea (OSA) is a common form of sleep disordered breathing characterized by partial or complete upper airway obstructions during sleep. OSA is associated with major comorbidities and perioperative complications. These complications are caused not only by the OSA itself, but also by exacerbations of this syndrome during the perioperative period (1). Benzodiazepines, volatile anesthetics and opioids may lead to lower hypoxia and hypercapnia sensitivity and may cause respiratory depression (2-5). Therefore, preference of neuraxial blockades and avoidance of opioids has been suggested for patients with OSA (6). However, there is still lack of evidence to evaluate the effects of various anesthesia procedures on OSA (6,7). We hypothesize different anesthetic procedures will have different effect on OSA exacerbations in the postoperative period. Accordingly, the aim of this study is to compare the number of sleep disordered breathing episodes in the postoperative period in patients with different anesthetic procedures.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Procedure: anesthesia

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Different Anesthetic Procedures on Sleep Disorder Breathing in Adult Patients Undergoing Elective Surgery
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
General anesthesia (with opioids)
orthopedic surgery plus general anesthesia
Procedure: anesthesia
Different anesthetic procedures

Epidural anesthesia (without opioids)
orthopedic surgery plus epidural anesthesia (without opioids use)
Procedure: anesthesia
Different anesthetic procedures

Subarachnoid anesthesia (with opioids)
orthopedic surgery plus subarachnoid anesthesia (plus intrathecal opioid)
Procedure: anesthesia
Different anesthetic procedures

Regional anesthesia (without opioids)
orthopedic surgery plus regional anesthesia (peripheral nerve block, continous or single shot, without opioid use)
Procedure: anesthesia
Different anesthetic procedures




Primary Outcome Measures :
  1. Apnea-hypopnea index change [ Time Frame: 4 nights after surgery ]
    Changes (post-pre) in apnea-hypopnea index 4 nights post surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
consecutive patients undergoing elective orthopedic surgery
Criteria

Inclusion Criteria:

  • elective orthopedic surgery

Exclusion Criteria:

  • already diagnosed sleep disorder breathing
  • continuous positive airway pressure therapy
  • tracheostomy
  • American Society of Anesthesiologists class IV-V

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499132


Locations
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Czechia
St. Anne's University Hospital Brno
Brno, Czech Republic, Czechia, 65691
Sponsors and Collaborators
St. Anne's University Hospital Brno, Czech Republic
Investigators
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Principal Investigator: Ivan Cundrle, M.D., Ph.D. St. Anne's University Hospital Brno

Publications:

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Responsible Party: Ivan Cundrle, M.D., Ph.D., St. Anne's University Hospital Brno, Czech Republic
ClinicalTrials.gov Identifier: NCT03499132    
Other Study ID Numbers: IIT/2017/30
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic:
anesthesia, obstructive sleep apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Wake Disorders
Parasomnias
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Analgesics, Opioid
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents