Impact of OFA During LPV on Postoperative Oxygen Saturation

Decreased Lung Compliance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660306
• Other study ID #: OS impact OFA on SAT d LPV
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: November 5, 2019

Study information

• Verified date: December 2019
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 5, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Decreased Lung Compliance
• Oxygen Requirement

Intervention

Procedure:
• opioid anesthesia
opioid anesthesia means using sufentanil during surgery
• opioid free anesthesia
opioid free anesthesia means giving no opioids during surgery

Locations

Country	Name	City	State
Belgium	Azsintjan	Brugge

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygen requirement post operative to maintain saturation above 94%	oxygen saturation	first 24 hours post operative
Secondary	postoperative pain	postoperative pain measured by VAS score	first 24 hours post operative
Secondary	postoperative opioid consumption	postoperative opioid consumption measured by morphine equivalents	first 24 hours post operative