Influence of Different Anesthetic Procedures on Sleep Disorder Breathing

Obstructive Sleep Apnea Clinical Trial

Official title:

Influence of Different Anesthetic Procedures on Sleep Disorder Breathing in Adult Patients Undergoing Elective Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499132
• Other study ID #: IIT/2017/30
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: St. Anne's University Hospital Brno, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 1, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Wake Disorders

Intervention

Procedure:
• anesthesia
Different anesthetic procedures

Locations

Country	Name	City	State
Czechia	St. Anne's University Hospital Brno	Brno	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (7)

Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82. — View 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. Review. — View Citation

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index change	Changes (post-pre) in apnea-hypopnea index 4 nights post surgery	4 nights after surgery