Spinal Morphine for Patients With Obstructive Sleep Apnea

March 15, 2019 updated by: University Health Network, Toronto

Low Dose Spinal Morphine for Patients With Obstructive Sleep Apnea (OSA) Undergoing Total Hip Arthroplasty (THA)

Patients with Obstructive Sleep Apnea (OSA) appear to be especially vulnerable to medications that suppress pharyngeal muscle activity such as general anesthetics and opioids. Opioids can depress the ventilator response to airway obstruction and inhibit the awakening response to hypoxia and hypercarbia, resulting in central respiratory depression. OSA is therefore an important risk factor for serious postoperative complications, including perioperative death. While OSA is increasingly recognized as a serious perioperative concern, current clinical practices are highly inconsistent with regard to the management of surgical patients with OSA. Additionally, the relative safety of intrathecal opioids in this patient population remains unknown.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Total hip and knee arthroplasty (THA and TKA) are among the most common orthopedic procedures performed worldwide1. They have been shown to reduce chronic pain, increase the ability to function independently, and improve quality of life2,3. With an aging and increasingly obese North American population, the uses of THA and TKA are increasing 4. One of the main challenges associated with THA as well as TKA continues to be the perioperative management of patients who are elderly or obese, and their associated co-morbidities. Both THA and TKA are commonly performed under neuraxial anesthesia. Neuraxial anesthesia has been reported to provide multiple benefits when compared to general anesthesia and/or systemic analgesia including superior post-operative analgesia5, reduced opioid consumption6, improved rehabilitation7, and reduced morbidity and mortality8-12. The addition of opioids to the neuraxial local anesthetic solution has been common practice since 1979, when morphine was first shown to provide effective and prolonged analgesia after intrathecal administration13. For both THA and TKA surgeries, intrathecal morphine provides effective analgesia14-16 allowing for a reduction of the dose of intrathecal local anesthetic (thus minimizing side effects)17, and has a marked postoperative opioid-sparing effect14-16. However, these benefits of intrathecal morphine must be weighed against its risks of pruritis, nausea/vomiting, urinary retention, and, of most concern, respiratory depression18.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults, aged 18-85
  2. ASA physical status I-III
  3. Suspected of having Obstructive Sleep Apnea(OSA) or previously diagnosed with OSA
  4. Scheduled to undergo elective primary Total Hip or Knee Arthroplasty

Exclusion Criteria:

  1. Chronic obstructive pulmonary disease
  2. Asthma
  3. History of congestive heart failure
  4. Valvular disease
  5. Dilated cardiomyopathy
  6. Implanted pacemaker or defibrillator
  7. Diagnosed OSA who are undergoing continuous positive airway pressure (CPAP) treatment
  8. Contraindications to spinal anesthesia
  9. Contraindications to a component of multi-modal analgesia
  10. Local anesthetic allergy
  11. Anticipated surgical duration > 2.5hrs
  12. Opioid tolerance (>250mg/24hr oral morphine equivalent pre-operatively)
  13. Pregnancy
  14. History of significant cognitive or psychiatric condition that may affect patient assessment, or
  15. Inability to provide informed consent.
  16. Participation in other clinical studies

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intrathecal morphine
100μg of morphine will be added to the intrathecal mixture.
Drug: Intrathecal Morphine
Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture.
Other Names:
  • Kadian
Active Comparator: No Intrathecal morphine
Morphine will not be added to the intrathecal mixture.
Drug: No Intrathecal Morphine
Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture.
Other Names:
  • Kadian

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Oxygen Desaturation Index (ODI) for the first 72 hours postoperatively.
Time Frame: 72 hours
Oxygen Desaturation Index (ODI) is defined as the average number of episodes of desaturation ≥ 4% lasting at least 10 seconds, per hour of sleep. ODI will be measured with a nocturnal pulse oximeter.
72 hours

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Richard Brull, MD, University of Toronto

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 15, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0460-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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