ClinicalTrials.gg
RecruitingNCT07227389Updated Jul 16, 2026

Timing of Opioid Administration and Postoperative Respiratory Depression.

An observational study in Respiratory Complications, Opioid Induced Respiratory Depression and Postoperative Respiratory Complications, sponsored by Wayne State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Wayne State University · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

Opioids have been used as a mainstay of perioperative analgesia since the late 18th century. The use of opioids, however, is not without risk as both short-term and long-term complications have been reported leading to in-hospital morbidity as well as increased 30-day readmission. Multiple postoperative complications are attributed to opioid administration including respiratory, cardiovascular, neurological, and gastrointestinal. As such, the routine use of opioids postoperatively is constantly being re-evaluated in search of better alternatives. For the time being, opioid prescription is largely provider dependent and hence the complications are varied. Opioids act on central and peripheral receptors leading to analgesia, but also cause worsening sleep apnea, decreased ventilatory response to hypoxia and hypercarbia, and may lead to hyperalgesia and sedation, thus feeding a vicious cycle. Certain patient populations have increased analgesic demand postoperatively and are thus at increased risk of postoperative opioid-induced respiratory depression (OIRD). This is especially true in patients with morbid obesity, chronic opioid use, obstructive sleep apnea (OSA), or sleep-disordered breathing (SDB). Higher risk patients also include those with concomitant pulmonary disease. The morbidity and mortality are even higher in the unmonitored setting. Current efforts at monitoring postoperative patients are mostly intermittent peripheral oximetry checks by the inpatient ward staff unless the patient is present in a step-down or intensive care unit. There are no clear guidelines on continuous postoperative oxygenation monitoring mostly due to the lack of published data. Intermittent checks are typically done every four or eight hours and are generally suboptimal at detecting episodes of hypoxemia. Other indirect methods of measuring hypoxemia include incidence of naloxone administration and/or code blue (cardio-respiratory arrest) emergencies. While continuous peripheral pulse oximetry in the postoperative period is currently the best available means to detect hypoxemia, it is not without flaws. Several factors can lead to falsely decreased measured oxygen saturation including motion artifacts, cold fingers, and sleep position. Oximetry would also detect hypoxemia after the oxygen reserves have been depleted, which is usually later in the process. Most preventable deaths attributable to OIRD seem to occur shortly after release from the post-anesthesia care unit (PACU) and are more likely during the night shift or during other times of decreased nursing availability. Noninvasive continuous respiratory monitoring is possible using a novel respiratory volume monitor (RVM) that utilizes bio-impedance to detect tidal volumes, respiratory rate, and minute ventilation in non-intubated patients (ExSpiron). The realtime minute ventilation (MV) as obtained from the RVM is contrasted with the calculated predicted MV according to the patients size and gender to end up with a percent of the predicted MV (%MVPRED) that relates to the degree of respiratory depression. The use and quantification of this ratio can aid in analyzing the respiratory effect that an opioid dose can have on the patient. Where a MVPRED of 80% can relate to mild respiratory depression. Here the investigators aim to capture the influence of opioid dosage on minute ventilation, with a primary outcome of a %MVPRED reduction of at least 20%. Respiratory Metrics: Respiratory metrics, including MV, %MVPRED, TV, and RR will be recorded by the Respiratory Volume Monitor (ExSpiron, Senzime, Uppsala, Sweden). Metrics will be recorded every 5 seconds and calculated as an average of the previous 30-second window. De-identified respiratory metric data will be downloaded directly from each patient every day and at the completion of the study using the built-in user interface. Clinicians will be asked to record the precise time of any respiratory interventions.

Rationale for conducting the research: The researchers propose to evaluate the effect of opioids on respiratory depression as monitored by a non-invasive respiratory volume monitor on postoperative non-intubated patients. Primarily, the aim is to determine the correlation between opioid administration and decreased respiratory function. More specifically, the immediate effect that opioid administration has on minute ventilation. In order to test this relationship, the researchers put forward a blinded observation study on adult patients in the PACU who require pain management with opioids.

Rationale for the selected participant population: Patients in the PACU often require pain management with opioids. Monitoring these patients with a non-invasive respiratory monitor for opioid induced respiratory depression (OIRD) may potentially detect adverse events earlier than conventional standard of care monitors.

02

Conditions studied

  • Respiratory Complications
  • Opioid Induced Respiratory Depression
  • Postoperative Respiratory Complications

Keywords

  • opioids
  • bio-impedance
  • hypoxia
  • hypercapnia
  • minute ventilation
03

In context

Hypoxia

1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.

This study's planned enrollment of 52 is below the median of 79 across 277 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written
  • 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

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
  • (ASA) classification V
  • Emergency surgery (ASA E Modifier)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Study group

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

    Diagnostic Test: Respiratory volume monitoring

Interventions

  • Diagnostic testRespiratory volume monitoring

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

06

What researchers measure

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)

  5. Hypoxia

    Hypoxic episodes episode as measured by SpO2

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

  6. Patient transfer occurrence

    Patient transfer to higher/lower acuity level such as ICU, hospital floor, step-down unit

    Time frame: During patient stay (up to 30 days)

  7. Initiation of patient prone position placement

    Occurance time of patient placement into the prone position

    Time frame: During patient PACU stay (up to 4 hours)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2028, 34 months after the start.

Of 125 non-industry observational studies under Hypoxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 74. This study's planned 34 months is above that.

Counting every sponsor, half of 155 studies reached it within 14 months; a quarter within 3 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2025
First posted
Nov 12, 2025
StartActual
Feb 1, 2026
Primary completionEst.
Dec 1, 2028
CompletionEst.
Feb 1, 2029
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07227389
Responsible party
Wael Saasouh, MD (Clinical Assistant Professor, Wayne State University) — Principal investigator
First posted
Nov 12, 2025
Start date
Feb 1, 2026
Primary completion
Dec 1, 2028 (estimated)
Completion
Feb 1, 2029 (estimated)
Last update
Jul 16, 2026

Study contacts

George M McKelvey, PhD
Contact
George.McKelvey@northstaranesthesia.com
3135986036
Wael Saasouh, MD
principal investigator · Wayne State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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