Recruiting

Opioid Administration

Sponsor:

Wayne State University

Code:

NCT07227389

Conditions

Respiratory Complications

Opioid Induced Respiratory Depression

Postoperative Respiratory Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Respiratory volume monitoring

Study Details

Brief summary:

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.

Conditions

Respiratory Complications

Opioid Induced Respiratory Depression

Postoperative Respiratory Complications

Study ID

NCT07227389

Start date

Feb 1, 2026

Status verified date

Jul, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-operative procedure (imaging)
  • Patients not admitted to the PACU postoperatively
  • Use of patient-controlled analgesia systems
  • Female patients who are pregnant or breastfeeding
  • Patients with asymmetric lung disease
  • American Society of Anesthesiologists (ASA) classification V
  • Emergency surgery (ASA E Modifier)

Study Design

Enrollment

52 participants

Anticipated

Interventions and Outcome Measures

Arms

Study group

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

Interventions

Respiratory volume monitoring

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

Primary outcome measure

  • Respiratory interventions 1 [ Time Frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit (PACU) ]
  • Respiratory interventions 2 [ Time Frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit ]
  • Respiratory interventions 3 [ Time Frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit ]
  • Respiratory interventions 4 [ Time Frame: Within 4 hours of patient admittance to Post Anesthetic Care Unit ]

Central Contacts and Locations

Central contacts

George M McKelvey, PhD

3135986036George.McKelvey@northstaranesthesia.com

Locations

Detroit Medical Center

Recruiting

Detroit, Michigan, United States, 48201

Contacts

George McKelvey M Clinical Co-ordinator, PhD

3135986036George.McKelvey@northstaranesthesia.com

More Information

Sponsor

Wayne State University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • opioids
  • bio-impedance
  • hypoxia
  • hypercapnia
  • minute ventilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2026-07-16.