Opioid-free Anesthesia and Thoracoscopy Surgery
OFAT
Evaluation of an "Opioid Free Anesthesia" Protocol in Thoracoscopic Carcinological Thoracic Surgery
1 other identifier
observational
90
1 country
1
Brief Summary
Evaluation of a service OFA (Opioid-free Anesthesia) protocol on post-operative pain of patients operated on by video-thoracoscopic carcinologic surgery by counting them to a group of patients receiving standard general anesthesia with opioid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedStudy Start
First participant enrolled
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedSeptember 13, 2023
September 1, 2023
1.1 years
February 15, 2022
September 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphine consumption
Total morphine consumption over the first 48 post operative hours in milligrammes
Day 2
Secondary Outcomes (7)
Preoperatory haemodynamic tolerance
Day 0
Quality of intraoperative anesthesia
Day 0
Ileus Postoperative
Day 4
Duration of hospitalization
Day 10
Chronic neuropathic pain
Month-3
- +2 more secondary outcomes
Study Arms (2)
OFA : Opioid Free Anesthesia
Opioid-free surgery. Analgesia provided by attenuation analgesic 1, dexmedetomidine, ketamine and general anesthesia by propofol. Regional loco anesthesia is performed in the OFA group and possible in the OBA group. It's local service protocol used since 1 year.
OBA : Opioid Based Anesthesia
Conventional anesthesia with Propofol and Sufentanil boli with the possibility of regional loco anesthesia.
Eligibility Criteria
Adult patients undergoing lung oncology surgery under video-thoracoscopy lasting more than 2 hours. Patients will be randomly assigned to a group without a random draw. Only the anesthesiologist trained at the OFA will be able to do the OFA
You may qualify if:
- Adult patient
- Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours
You may not qualify if:
- Patient with unstable unstable unstable coronary artery disease,
- Patient contraindicated for the use of dexmedetomidine: heart rate\<50 / min, High degree atrioventricular block (2 and 3) unless fitted (carrier of a pacemaker),
- Patient on beta-blocker, allergy to Dexdor®,
- Patient allergic to other drugs used in OFA (Paracetamol and NSAIDs).
- Renal insufficiency patient with creatinine clearance\<30ml/min will not be excluded but will not receive NSAIDs.
- Minor patient,
- Adult patient under guardianship or curators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nantes
Nantes, 44093, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julien CADIET, PH
Nantes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2022
First Posted
April 4, 2022
Study Start
April 4, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share