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

The Impact of Postoperative Opioids on Duration and Severity of Desaturation and Bradypnea in Opioid-naïve and Chronic Opioid Patients, Assessed by Continuous Vital Sign Monitoring.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06227208
Enrollment
691
Registered
2024-01-26
Start date
2023-10-01
Completion date
2024-01-16
Last updated
2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Complication

Keywords

Opioid-induced respiratory depression, Postoperative opioid, Opioid-naïve patients, Chronic opioid patients, Desaturation, Bradypnea, Continuous monitoring, Patient safety

Brief 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

Detailed description

Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients within the first four hours following opioid administration in addition to the chronic dose, using a continuously wireless monitoring system. Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Continuous wireless monitoring data of peripheral tissue oxygenation (SpO2) and respiratory rate (RR) was conducted in postoperative patients. Data were stratified into opioid-naïve and chronic opioid patients, based on their preoperative opioid history. Patients who did not receive opioids postoperatively were served as the control group. Data was evaluated one hour before and four hours after opioid administration. The primary outcome was the cumulative duration of SpO2 \<88%.

Interventions

Wireless monitoring system that provided continuous, non-invasive collection of their vital signs, including peripheral oxygen saturation (SpO2) and respiratory rate (RR), for up to 92 hours following surgery or until discharge. The respiratory rate was monitored via FDA-approved Isansys Lifetouch electrocardiogram (ECG) patch, which was placed on the left side of the chest. SpO2 levels were continuously recorded using the Nonin WristOx 3150, a wrist-mounted finger oximeter.

Sponsors

Bispebjerg Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum

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%

Design outcomes

Primary

MeasureTime frame
SpO2 <88% in the four hours following opioid administrationfour hours following opioid administration

Secondary

MeasureTime frameDescription
Respiratory deviations four hours after opioid administrationfour hours following opioid administrationSpO2 \<92%, \<88 %, \<85%, \<80% and respiratory rate ≤11 min-1, ≤8 min-1, ≤5 min-1

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026