NCT01790971

Brief Summary

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
6.9 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

February 11, 2013

Last Update Submit

March 15, 2019

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaSpinal morphine

Outcome Measures

Primary Outcomes (1)

  • Average Oxygen Desaturation Index (ODI) for the first 72 hours postoperatively.

    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

Study Arms (2)

Intrathecal morphine

ACTIVE COMPARATOR

100μg of morphine will be added to the intrathecal mixture.

Drug: Intrathecal Morphine

No Intrathecal morphine

ACTIVE COMPARATOR

Morphine will not be added to the intrathecal mixture.

Drug: No Intrathecal Morphine

Interventions

Intrathecal MorphineDRUG

Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture.

Also known as: Kadian
Intrathecal morphine
No Intrathecal MorphineDRUG

Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture.

Also known as: Kadian
No Intrathecal morphine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Chronic obstructive pulmonary disease
  • Asthma
  • History of congestive heart failure
  • Valvular disease
  • Dilated cardiomyopathy
  • Implanted pacemaker or defibrillator
  • Diagnosed OSA who are undergoing continuous positive airway pressure (CPAP) treatment
  • Contraindications to spinal anesthesia
  • Contraindications to a component of multi-modal analgesia
  • Local anesthetic allergy
  • Anticipated surgical duration \> 2.5hrs
  • Opioid tolerance (\>250mg/24hr oral morphine equivalent pre-operatively)
  • Pregnancy
  • History of significant cognitive or psychiatric condition that may affect patient assessment, or
  • Inability to provide informed consent.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

  • Liu SS, Wu CL. The effect of analgesic technique on postoperative patient-reported outcomes including analgesia: a systematic review. Anesth Analg. 2007 Sep;105(3):789-808. doi: 10.1213/01.ane.0000278089.16848.1e.

    PMID: 17717242BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Morphine

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Richard Brull, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 13, 2013

Study Start

January 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

CA(1)