Clinical trial NCT06227208: Postoperative Opioid and Respiratory Depression in Opioid Naive and Chronic Opioid Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Complication
Keywords: Opioid-induced respiratory depression
Postoperative opioid
Opioid-naïve patients
Chronic opioid patients
Desaturation
Bradypnea
Continuous monitoring
Patient safety
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2024-01-26
Enrollment: 691
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from studies WARD Surgery Observational \[gov: NCT03491137\] and the control group from a WARD Surgery Randomized Controlled Trial (RCT) \[gov: NCT04640415 - submitted\] were assessed for inclusion eligibility.

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%.

Eligibility criteria: 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%

Primary outcomes:
measure: SpO2 <88% in the four hours following opioid administration
timeFrame: four hours following opioid administration
Secondary outcomes:
measure: Respiratory deviations four hours after opioid administration
timeFrame: four hours following opioid administration
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske Kvanner Aasvang, Professor
role: STUDY_CHAIR
References: