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Clinical Trials/NCT03660306
NCT03660306
Completed
N/A

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

AZ Sint-Jan AV1 site in 1 country64 target enrollmentAugust 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Decreased Lung Compliance
Sponsor
AZ Sint-Jan AV
Enrollment
64
Locations
1
Primary Endpoint
oxygen requirement post operative to maintain saturation above 94%
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
November 5, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jan Mulier

MD PhD

AZ Sint-Jan AV

Eligibility Criteria

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

Outcomes

Primary Outcomes

oxygen requirement post operative to maintain saturation above 94%

Time Frame: first 24 hours post operative

oxygen saturation

Secondary Outcomes

  • postoperative pain(first 24 hours post operative)
  • postoperative opioid consumption(first 24 hours post operative)

Study Sites (1)

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