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Timing of Opioid Administration and Postoperative Respiratory Depression.

ConditionsRespiratory ComplicationsOpioid Induced Respiratory DepressionPostoperative Respiratory Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorWayne State University

About this trial

The goal of this study is to determine if a relationship can be detected between the administration of an opioid and quantitative respiratory depression in spontaneously breathing non-intubated patients who have undergone general anesthesia and have received perioperative opioids.

The primary aim is to determine the temporal effect of opioid administration on respiratory depression as assessed by minute ventilation with a reduction of at least 20% in the percent of predicted minute ventilation.

A secondary aim is to determine a dose response of opioid administration and its effect on minute ventilation.

The investigators aim to determine the influence of opioid administration on minute ventilation on spontaneously breathing patients during post-anesthesia care unit (PACU) stay.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Written informed consent

Adults ≥18 years of age and ≤85 years of age

Patients planned for general anesthesia with an expected anesthetic time of at least 2 hours

Patients expected to receive postoperative opioid analgesia

Disqualifiers

Non-operative procedure (imaging)

Patients not admitted to the PACU postoperatively

Use of patient-controlled analgesia systems

Female patients who are pregnant or breastfeeding

Trial population

Surgical patients receiving general anesthesia with an expected anesthetic time of at least 2 hours

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Respiratory volume monitoring

    Diagnostic test

    Noninvasive continuous respiratory monitoring utilizing bio-impedance to detect tidal volumes, respiratory rate, and minute ventilation.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: Study group1 intervention

Trial outcomes

Primary outcomes

1

Respiratory interventions 1

Initiation or cessation of mechanical ventilation

Time frame
Within 4 hours of patient admittance to Post Anesthetic Care Unit (PACU)
2

Respiratory interventions 2

Initiation or cessation of Bilevel Positive Airway Pressure

Time frame
Within 4 hours of patient admittance to Post Anesthetic Care Unit
3

Respiratory interventions 3

Initiation/cessation of high flow nasal cannula

Time frame
Within 4 hours of patient admittance to Post Anesthetic Care Unit
4

Respiratory interventions 4

Initiation/cessation of low flow nasal cannula

Time frame
Within 4 hours of patient admittance to Post Anesthetic Care Unit

Secondary outcomes

1

Oxygen saturation of peripheral blood (SpO2)

Oxygen saturation of peripheral blood during PACU stay

Time frame
Duration of PACU stay (up to 4 hours)
2

Arterial Blood gas levels

Arterial Blood gas levels during surgery

Time frame
Duration of surgery (up to 2hrs)
3

Venous Blood gas levels

Venousl Blood gas levels during surgery

Time frame
Duration of surgery (up to 2hrs)
4

Hypercapnia

Hypercapnic episode as measured by EtCO2

Time frame
Duration of patient stay in PACU (up to 4 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayne State University

Lead sponsor

Source ClinicalTrials.gov
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