Influence of Different Anesthetic Procedures on Sleep Disorder Breathing

NCT03499132 | Completed

• 1 other identifier: IIT/2017/30
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

anesthesia, obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index change

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

  4 nights after surgery

Study Arms (4)

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

anesthesia PROCEDURE

Different anesthetic procedures

Epidural anesthesia (without opioids); General anesthesia (with opioids); Regional anesthesia (without opioids); Subarachnoid anesthesia (with opioids)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients undergoing elective orthopedic surgery

You may qualify if:

• elective orthopedic surgery

You may not qualify if:

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

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead

Study Sites (1)

St. Anne's University Hospital Brno

Brno, Czech Republic, 65691, Czechia

Location

Related Publications (7)

• 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.

  PMID: 24158050 BACKGROUND

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

  PMID: 3354874 BACKGROUND

• 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.

  PMID: 1128555 BACKGROUND

• 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.

  PMID: 8024126 BACKGROUND

• 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.

  PMID: 7661348 BACKGROUND

• 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.

  PMID: 24346178 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

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Ivan Cundrle, M.D., Ph.D.

  St. Anne's University Hospital Brno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: April 8, 2018
• First Posted: April 17, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: March 1, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)