The investigator will evaluate the side effects of oliceridine.
The investigator will evaluate the side effects of oliceridine. Limited information suggests that oliceridine may cause fewer side effects than the standard opioids given post surgery. Oliceridine is effective for treating acute pain, and is approved by the FDA. Patients will wear a device that continuously monitors breathing. Data from this monitor will be blinded to the clinical staff. Primary Aims include: The investigators will evaluate the proportion of patients having an adjudicated meaningful respiratory compromise with a specified precision of 0.15 using a 95% confidence interval at 24 hours post first study dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
111
Near the end of surgery, patients will be given ≤1.5 mg of oliceridine as a bolus. Postoperatively, patient-controlled analgesia (PCA) will be started with no background infusion, demand doses of 0.35 mg, with a 6 minute lock-out. Additional boluses (≤1 mg) of oliceridine will be given as deemed necessary (based on NRS score and clinical assessment of the patient) as soon as 15 minutes after the initial 1.5 mg loading dose. In addition to supplemental 1 mg bolus doses, the PCA demand dose can be increased to a maximum of 0.5 mg oliceridine.
Wake Forest Bapist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Number of patients who have respiratory compromise.
Respiratory compromise will be defined by a collapsed (one or more) composite of 1) end-tidal carbon dioxide \<15mmHg for ≥3 minutes; 2) respiratory rate ≤5 breaths/minute for ≥3 minutes; 3) SpO2 ≤ 85% for ≥3 minutes; 4) Apnea episode lasting \>30 seconds; 5)any serious respiratory event.
Time frame: 24 hours post first study dose.
Cumulative duration of oxygen saturation < 90%
The sum of minutes with SpO2\<90% from monitoring data
Time frame: 48 hours post first study dose.
Cumulative duration of respiratory rate < 8 breaths/ minute
The sum of minutes with respiratory rate \< 8 from monitoring data
Time frame: 48 hours post first study dose.
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