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CompletedNCT03660306Updated Dec 3, 2019

Impact of OFA During LPV on Postoperative Oxygen Saturation

An observational study in Decreased Lung Compliance and Oxygen Requirement, sponsored by AZ Sint-Jan AV. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by AZ Sint-Jan AV · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years and older
Sex
All
01

Study summary

Opioids used intra operative increase the amount of opioids needed post operative to control post operative pain. if opioids are given post operative, we assume that more atelectasis and hypoxia takes place even after lung protective ventilation. These postoperative lower oxygen saturations will require giving more frequent oxygen therapy.

Read the detailed description

This is an observational study where the attending anesthesiologist decides to use opioid free or opioid general anesthesia based on his/her expertise.

Every patient gets a lung protective ventilation and emergence from anesthesia using the principles set forward in the consensus meeting by Young C BJA 2019.

A lung recruitment followed by high PEEP is given when lung compliance decreases below 40 ML/cmH20. The lowest oxygen saturation without adding oxygen therapy is noted post extubation at moment of admission in PACU, after having given an opioid as analgesic and at moment of discharge from PACU..

If post operative satuation drops below 94% oxygen therapy is given and noted.

02

Conditions studied

  • Decreased Lung Compliance
  • Oxygen Requirement
03

In context

Lead sponsor

AZ Sint-Jan AV is the lead sponsor of 58 studies on the registry; 14 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Major surgery requiring intubation and mechanical ventilation.

Inclusion criteria

  • major surgery where intubation with mechanical ventilation is required
  • obese patients with BMI > 35

Exclusion criteria

Exclusion Criteria:

  • spontaneous breathing during procedure
  • allergic to any of the drugs used in both groups
  • severe liver, renal, cardiac or pulmonary disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (actual)
Patient registry
No

Groups and cohorts

  • opioid anesthesia

    classical anesthesia using sufentanil to block sympathetic reactions during surgery. This decision is based on the anesthesiologist experience and not determined by the patient or procedure.

    Procedure: opioid anesthesia

  • opioid free anesthesia

    anesthesia using non opioids like dexmedetomidine, lidocaine, magnesium and ketamine to block sympathetic reactions during surgery. This decision is based on the anesthesiologist experience and not determined by the patient or procedure.

    Procedure: opioid free anesthesia

Interventions

  • Procedureopioid anesthesia

    opioid anesthesia means using sufentanil during surgery

  • Procedureopioid free anesthesia

    opioid free anesthesia means giving no opioids during surgery

06

What researchers measure

Primary outcomes

  1. oxygen requirement post operative to maintain saturation above 94%

    oxygen saturation

    Time frame: first 24 hours post operative

Secondary outcomes

  1. postoperative pain

    postoperative pain measured by VAS score

    Time frame: first 24 hours post operative

  2. postoperative opioid consumption

    postoperative opioid consumption measured by morphine equivalents

    Time frame: first 24 hours post operative

07

Study locations

1 site
  • Azsintjan
    Brugge, 8000, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03660306
Lead sponsor
AZ Sint-Jan AV
Responsible party
Jan Mulier (MD PhD, AZ Sint-Jan AV) — Principal investigator
First posted
Sep 6, 2018
Start date
Aug 1, 2018
Primary completion
Oct 31, 2019
Completion
Nov 5, 2019
Last update
Dec 3, 2019

Study contacts

Marco Lanckneus, MD
study director · AZ Sint-Jan AV

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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