Impact of OFA During LPV on Postoperative Oxygen Saturation

Completed

• Conditions: Oxygen Requirement; Decreased Lung Compliance
• Interventions: Procedure: opioid anesthesia; Procedure: opioid free anesthesia

• Registration Number: NCT03660306
• Lead Sponsor: AZ Sint-Jan AV

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Primary Completion: 2019-10-31
• Study Completion: 2019-11-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-01
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
opioid anesthesia	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.
opioid free 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.

Primary Outcome Measures

Name	Time	Method
oxygen requirement post operative to maintain saturation above 94%	first 24 hours post operative	oxygen saturation

Secondary Outcome Measures

Name	Time	Method
postoperative pain	first 24 hours post operative	postoperative pain measured by VAS score
postoperative opioid consumption	first 24 hours post operative	postoperative opioid consumption measured by morphine equivalents

Trial Locations

Locations (1)

Azsintjan; 🇧🇪 Brugge, Belgium