Search / Trial NCT06227208

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

Launched by RIGSHOSPITALET, DENMARK · Jan 17, 2024

Trial Information

Current as of December 21, 2024

Completed

Keywords

Opioid Induced Respiratory Depression Postoperative Opioid Opioid Naïve Patients Chronic Opioid Patients Desaturation Bradypnea Continuous Monitoring Patient Safety

ClinConnect Summary

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...

Gender

ALL

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%

Trial Officials

Eske Kvanner Aasvang, Professor

Study Chair

Rigshospitalet, Denmark

About Rigshospitalet, Denmark

Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.

Locations

Copenhagen, , Denmark

Copenhagen, , Denmark

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0