Influence of Different Anesthetic Procedures on Sleep Disorder Breathing

NCT ID: NCT03499132

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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General anesthesia (with opioids)

orthopedic surgery plus general anesthesia

anesthesia

Intervention Type PROCEDURE

Different anesthetic procedures

Epidural anesthesia (without opioids)

orthopedic surgery plus epidural anesthesia (without opioids use)

anesthesia

Intervention Type PROCEDURE

Different anesthetic procedures

Subarachnoid anesthesia (with opioids)

orthopedic surgery plus subarachnoid anesthesia (plus intrathecal opioid)

anesthesia

Intervention Type PROCEDURE

Different anesthetic procedures

Regional anesthesia (without opioids)

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

anesthesia

Intervention Type PROCEDURE

Different anesthetic procedures

Interventions

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anesthesia

Different anesthetic procedures

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Anne's University Hospital Brno, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Ivan Cundrle

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivan Cundrle, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St. Anne's University Hospital Brno

Locations

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St. Anne's University Hospital Brno

Brno, Czech Republic, Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 24158050 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3354874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1128555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8024126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7661348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24346178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29300271 (View on PubMed)

Other Identifiers

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IIT/2017/30

Identifier Type: -

Identifier Source: org_study_id

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