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OpenTrials
Completed

NCT Number: NCT03660306

Impact of OFA During LPV on Postoperative Oxygen Saturation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azsintjan

Bruges, 8000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Opioid Anesthesia

Procedure

opioid anesthesia means using sufentanil during surgery

opioid free anesthesia

Procedure

opioid free anesthesia means giving no opioids during surgery

Primary outcomes

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

    Time frame: first 24 hours post operative

    oxygen saturation

Secondary outcomes

  1. postoperative pain

    Time frame: first 24 hours post operative

    postoperative pain measured by VAS score

  2. postoperative opioid consumption

    Time frame: first 24 hours post operative

    postoperative opioid consumption measured by morphine equivalents

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study title

Observational Study Evaluating the Impact of Opioid Free Anesthesia During Lung Protective Ventilation on Postoperative Oxygen Saturation.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2018
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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