Clinical trial NCT03499132: Influence of Different Anesthetic Procedures on Sleep Disorder Breathing
Official title: Influence of Different Anesthetic Procedures on Sleep Disorder Breathing in Adult Patients Undergoing Elective Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: anesthesia, obstructive sleep apnea
Lead sponsor: St. Anne's University Hospital Brno, Czech Republic
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients undergoing elective orthopedic surgery

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.


Eligibility 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

Primary outcomes:
measure: Apnea-hypopnea index change
timeFrame: 4 nights after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: St. Anne's University Hospital Brno
state: Czech Republic
Study officials:
affiliation: St. Anne's University Hospital Brno
name: Ivan Cundrle, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.