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

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Rigshospitalet

Status

Completed

Conditions

Medical Complication

Treatments

Device: Continuous vital sign monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT06227208
WARD-postoperative-opioid

Details and patient eligibility

About

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

Full 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%.

Enrollment

691 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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%

Trial design

691 participants in 3 patient groups

Opioid-naive patients
Description:
Opioid-naive patients are defined as the absence of any documented opioid use in the available preoperatively medical records, and are receiving opioids postoperatively
Treatment:
Device: Continuous vital sign monitoring
Chronic opioid patients
Description:
Chronic opioid patients were defined as current or previous use of the following medications, re-gardless of the duration of use: morphine, tramadol, tapentadol, fentanyl, oxycodone, ketobe-midone, methadone, or buprenorphine. This was verified through patients' preoperative medical records. All chronic opioid users received postoperative opioids.
Treatment:
Device: Continuous vital sign monitoring
Control group
Description:
Patients who did not receive pre- or postoperative opioids were served as the overall control group.
Treatment:
Device: Continuous vital sign monitoring

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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