Impact of OFA During LPV on Postoperative Oxygen Saturation

Observational Study Evaluating the Impact of Opioid Free Anesthesia During Lung Protective Ventilation 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.

Study Overview

• Status: Completed
• Conditions: Decreased Lung Compliance; Oxygen Requirement
• Intervention / Treatment: Procedure: opioid anesthesia; Procedure: opioid free anesthesia

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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Azsintjan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Major surgery requiring intubation and mechanical ventilation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 anesthesia means using sufentanil during surgery
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; opioid free anesthesia means giving no opioids during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen requirement post operative to maintain saturation above 94%	oxygen saturation	first 24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	postoperative pain measured by VAS score	first 24 hours post operative
postoperative opioid consumption	postoperative opioid consumption measured by morphine equivalents	first 24 hours post operative

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Investigators: Study Director: Marco Lanckneus, MD, AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 1, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Analgesics, Opioid
• Other Study ID Numbers: OS impact OFA on SAT d LPV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No