Timing of Opioid Administration and Postoperative Respiratory Depression.
Part of paid clinical trials in Mount Clemens, Michigan.
- Sponsor
- Wayne State University
- Study ID
- NCT07227389
- Status
- Not Yet Recruiting
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Conditions
- Opioid Induced Respiratory Depression
- Postoperative Respiratory Complications
- Respiratory Complications
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Accepted
Interventions
- Respiratory volume monitoring — DIAGNOSTIC_TESTNoninvasive continuous respiratory monitoring utilizing bio-impedance to detect tidal volumes, respiratory rate, and minute ventilation.
Study Details
The goal of this study is to determine if a relationship can be detected between the administration of an opioid and quantitative respiratory depression in spontaneously breathing non-intubated patients who have undergone general anesthesia and have received perioperative opioids. The primary aim is to determine the temporal effect of opioid administration on respiratory depression as assessed by minute ventilation with a reduction of at least 20% in the percent of predicted minute ventilation. A secondary aim is to determine a dose response of opioid administration and its effect on minute ventilation. The investigators aim to determine the influence of opioid administration on minute ventilation on spontaneously breathing patients during post-anesthesia care unit (PACU) stay.
Key Dates
- Start date
- Dec 31, 2025
- Status verified
- Nov 2025
- Primary completion
- Dec 1, 2028
- Completion
- Jan 1, 2029
Study Design
- Enrollment
- 52 participants (estimated)
Arms
- Arm: Study groupPatients receiving general anesthesia with an expected anesthetic time of at least 2 hours
Primary Outcome Measure
Respiratory interventions 1 [ Time Frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit (PACU) ]
Central Contacts
- George M McKelvey, PhD3135986036
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Detroit Medical Center | Mount Clemens | Michigan | 48043 | 3135986036 |
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