Influence of Different Anesthetic Procedures on Sleep Disorder Breathing

March 16, 2020 updated by: Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

consecutive patients undergoing elective orthopedic surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anesthesia (with opioids)
orthopedic surgery plus general anesthesia
Procedure: anesthesia
Different anesthetic procedures
Epidural anesthesia (without opioids)
orthopedic surgery plus epidural anesthesia (without opioids use)
Procedure: anesthesia
Different anesthetic procedures
Subarachnoid anesthesia (with opioids)
orthopedic surgery plus subarachnoid anesthesia (plus intrathecal opioid)
Procedure: anesthesia
Different anesthetic procedures
Regional anesthesia (without opioids)
orthopedic surgery plus regional anesthesia (peripheral nerve block, continous or single shot, without opioid use)
Procedure: anesthesia
Different anesthetic procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-hypopnea index change
Time Frame: 4 nights after surgery
Changes (post-pre) in apnea-hypopnea index 4 nights post surgery
4 nights after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anne's University Hospital Brno, Czech Republic

Investigators

  • Principal Investigator: Ivan Cundrle, M.D., Ph.D., St. Anne's University Hospital Brno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

April 8, 2018

First Submitted That Met QC Criteria

April 8, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT/2017/30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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