CompletedNot Applicable

Postoperative Opioid and Respiratory Depression in Opioid Naive and Chronic Opioid Patients

Denmark691 participantsStarted 2023-10-01

Plain-language summary

Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients. Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Outcome: Respiratory deviations four hours after opioid administration

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients from studies WARD Surgery Observational \[gov: NCT03491137\] * The control group from WARD Surgery Randomized Controlled Trial \[gov: NCT04640415\] Exclusion Criteria: * Less than 30 minutes of continuous monitoring data within the 60-minute window prior to opioid administration * Less than 120 minutes (\<50% of theoretical maximum) of monitoring data available during the four-hour observation period * Patients who received transdermal fentanyl as postoperative opioid * Patients with a baseline saturation or respiratory rate below the prespecified thresholds * Patients with a BMI of ≥40 or diagnosed with COPD were excluded in the analysis of SpO2 \<92%

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SpO2 <88% in the four hours following opioid administration

Timeframe: four hours following opioid administration

Trial details

NCT IDNCT06227208

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-01

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