Major Surgery
Conditions
Brief summary
The investigator will evaluate the side effects of oliceridine.
Detailed description
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.
Interventions
DRUGOliceridine
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.
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * American Society of Anesthesiologists physical status 1-4 * Scheduled for major noncardiac surgery expected to last at least 2 hours * Expected to remain hospitalized at least two postoperative nights * Scheduled for general endotracheal, spinal anesthesia, or the combination * Expected to require substantial opioid analgesia, defined as ≥20 mg morphine equivalents * Expected to have patient-controlled intravenous analgesia.
Exclusion criteria
* Are demented or otherwise cannot provide valid consent * Have contraindications to oliceridine * Used legal or illegal opioids chronically, defined as \>15 mg morphine equivalents for \>15 days during the month before consenting by history * Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring * Have planned epidural anesthesia/analgesia * Planned spinal morphine administration * Are designated Do Not Resuscitate, hospice, or receiving end of life therapy * Are expected to require postoperative mechanical ventilation or ICU admission * Are expected to receive intrathecal opioids * Are expected to receive gabapentin, pregabalin or other analgesic adjuvants * Use oxygen at home * Are unwilling or unable to comply fully with study procedures (including not tolerating the capnography cannula) * Are known to be pregnant or breastfeeding * Use CPAP at home * Have previously participated in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Meaningful Respiratory Compromise Events | 48 hours post first study dose. | Occurrence of clinically meaningful respiratory compromise events i.e. SpO2 ≤ 85 % for ≥3 min, etPCO2 ≤ 15 mmHg; ≥ 3 min, RR ≤ 5 bpm for ≥3 min, Apnea Event \>30 s |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel I Sessler, MD
The Cleveland Clinic
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 203 Participants |
| Post operative Pain Management Received Oliceridine only post operatively | 124 Participants |
| Post operative Pain Management Received Oliceridine with another opioid post operatively | 79 Participants |
| Region of Enrollment United States | 203 participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 203 |
| other Total, other adverse events | 45 / 203 |
| serious Total, serious adverse events | 0 / 203 |
Outcome results
None listed