NCT03660306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
Last Updated

December 3, 2019

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

September 4, 2018

Last Update Submit

December 1, 2019

Conditions

Decreased Lung ComplianceOxygen Requirement

Outcome Measures

Primary Outcomes (1)

  • oxygen requirement post operative to maintain saturation above 94%

    oxygen saturation

    first 24 hours post operative

Secondary Outcomes (2)

  • postoperative pain

    first 24 hours post operative

  • postoperative opioid consumption

    first 24 hours post operative

Study Arms (2)

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 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

Interventions

opioid anesthesiaPROCEDURE

opioid anesthesia means using sufentanil during surgery

opioid anesthesia
opioid free anesthesiaPROCEDURE

opioid free anesthesia means giving no opioids during surgery

opioid free anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major surgery requiring intubation and mechanical ventilation.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

Study Officials

  • Marco Lanckneus, MD

    AZ Sint-Jan AV

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

August 1, 2018

Primary Completion

October 31, 2019

Study Completion

November 5, 2019

Last Updated

December 3, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)