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CompletedNCT03499132Updated Mar 17, 2020

Influence of Different Anesthetic Procedures on Sleep Disorder Breathing

An observational study in Obstructive Sleep Apnea, sponsored by St. Anne's University Hospital Brno, Czech Republic. Completed at 1 site in Czechia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by St. Anne's University Hospital Brno, Czech Republic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • anesthesia, obstructive sleep apnea
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

consecutive patients undergoing elective orthopedic surgery

Inclusion criteria

  • elective orthopedic surgery

Exclusion criteria

Exclusion Criteria:

  • already diagnosed sleep disorder breathing
  • continuous positive airway pressure therapy
  • tracheostomy
  • American Society of Anesthesiologists class IV-V
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • General anesthesia (with opioids)

    orthopedic surgery plus general anesthesia

    Procedure: anesthesia

  • Epidural anesthesia (without opioids)

    orthopedic surgery plus epidural anesthesia (without opioids use)

    Procedure: anesthesia

  • Subarachnoid anesthesia (with opioids)

    orthopedic surgery plus subarachnoid anesthesia (plus intrathecal opioid)

    Procedure: anesthesia

  • Regional anesthesia (without opioids)

    orthopedic surgery plus regional anesthesia (peripheral nerve block, continous or single shot, without opioid use)

    Procedure: anesthesia

Interventions

  • Procedureanesthesia

    Different anesthetic procedures

05

What researchers measure

Primary outcomes

  1. Apnea-hypopnea index change

    Changes (post-pre) in apnea-hypopnea index 4 nights post surgery

    Time frame: 4 nights after surgery

06

Study locations

1 site
  • St. Anne's University Hospital Brno
    Brno, Czech Republic 65691, Czechia
07

References and documents

Publications

  • Chung F, Liao P, Elsaid H, Shapiro CM, Kang W. Factors associated with postoperative exacerbation of sleep-disordered breathing. Anesthesiology. 2014 Feb;120(2):299-311. doi: 10.1097/ALN.0000000000000041. PubMed 24158050 ↗
  • Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82. PubMed 3354874 ↗
  • Weil JV, McCullough RE, Kline JS, Sodal IE. Diminished ventilatory response to hypoxia and hypercapnia after morphine in normal man. N Engl J Med. 1975 May 22;292(21):1103-6. doi: 10.1056/NEJM197505222922106. PubMed 1128555 ↗
  • Dahan A, van den Elsen MJ, Berkenbosch A, DeGoede J, Olievier IC, van Kleef JW, Bovill JG. Effects of subanesthetic halothane on the ventilatory responses to hypercapnia and acute hypoxia in healthy volunteers. Anesthesiology. 1994 Apr;80(4):727-38. doi: 10.1097/00000542-199404000-00004. PubMed 8024126 ↗
  • van den Elsen M, Dahan A, DeGoede J, Berkenbosch A, van Kleef J. Influences of subanesthetic isoflurane on ventilatory control in humans. Anesthesiology. 1995 Sep;83(3):478-90. doi: 10.1097/00000542-199509000-00006. PubMed 7661348 ↗
  • American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available. PubMed 24346178 ↗
  • 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. PubMed 29300271 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03499132
Lead sponsor
St. Anne's University Hospital Brno, Czech Republic
Responsible party
Ivan Cundrle (M.D., Ph.D., St. Anne's University Hospital Brno, Czech Republic) — Principal investigator
First posted
Apr 17, 2018
Start date
Mar 1, 2018
Primary completion
Dec 31, 2019
Completion
Mar 1, 2020
Last update
Mar 17, 2020

Study contacts

Ivan Cundrle, M.D., Ph.D.
principal investigator · St. Anne's University Hospital Brno

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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