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

Completed

• Conditions: Medical Complication
• Interventions: Device: Continuous vital sign monitoring

• Registration Number: NCT06227208
• Lead Sponsor: Rigshospitalet, Denmark

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%.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-16
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-26
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 691

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Continuous vital sign monitoring	Patients who did not receive pre- or postoperative opioids were served as the overall control group.
Chronic opioid patients	Continuous vital sign monitoring	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.
Opioid-naive patients	Continuous vital sign monitoring	Opioid-naive patients are defined as the absence of any documented opioid use in the available preoperatively medical records, and are receiving opioids postoperatively

Primary Outcome Measures

Name	Time	Method
SpO2 <88% in the four hours following opioid administration	four hours following opioid administration

Secondary Outcome Measures

Name	Time	Method
Respiratory deviations four hours after opioid administration	four hours following opioid administration	SpO2 \<92%, \<88 %, \<85%, \<80% and respiratory rate ≤11 min-1, ≤8 min-1, ≤5 min-1

Trial Locations

Locations (2)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark