Trial Outcomes & Findings for Intravenous Oliceridine and Opioid-related Complications (NCT NCT04979247)
NCT ID: NCT04979247
Last Updated: 2026-05-14
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
204 participants
Primary outcome timeframe
48 hours post first study dose.
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Oliceridine
Patients receive Oliceridine for pain control.
Oliceridine: 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.
|
|---|---|
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Overall Study
STARTED
|
204
|
|
Overall Study
COMPLETED
|
203
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Oliceridine
Patients receive Oliceridine for pain control.
Oliceridine: 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.
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|---|---|
|
Overall Study
Did not receive oliceridine
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oliceridine
n=203 Participants
Patients receive Oliceridine for pain control.
Oliceridine: 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.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=203 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
203 Participants
n=203 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=203 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=203 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=203 Participants
|
|
Region of Enrollment
United States
|
203 participants
n=203 Participants
|
|
Post operative Pain Management
Received Oliceridine only post operatively
|
124 Participants
n=203 Participants
|
|
Post operative Pain Management
Received Oliceridine with another opioid post operatively
|
79 Participants
n=203 Participants
|
PRIMARY outcome
Timeframe: 48 hours post first study dose.Population: all enrolled participants
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
Outcome measures
| Measure |
Oliceridine
n=204 Participants
Patients receive Oliceridine for pain control.
Oliceridine: 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.
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|---|---|
|
Clinically Meaningful Respiratory Compromise Events
|
45 Events
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Adverse Events
Oliceridine
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oliceridine
n=203 participants at risk
Patients receive Oliceridine for pain control.
Oliceridine: 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.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Clinically Meaningful Respiratory Compromise Events
|
22.2%
45/203 • Number of events 174 • 48 hours post operative
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place