Intravenous Oliceridine and Opioid-related Complications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2024-01-10

Brief Summary

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The investigator will evaluate the side effects of oliceridine.

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Detailed Description

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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.

Conditions

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Major Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Oliceridine

Patients receive Oliceridine for pain control.

Group Type EXPERIMENTAL

Oliceridine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No