Severe ObesityBARIANCT06162416
Non-opioid Anesthesia in Bariatric Surgery
An observational study of Severe Obesity, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Opioid-free anesthesia is a new approach to anesthesia, described and used for many years. If it represents many advantages by reducing the side effects of morphine, its precise place in current practice and in terms of postoperative rehabilitation remains to be determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Obesity
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject (≥ 18 years old) who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019
Who may be able to join
- Major subject (≥ 18 years old),
- who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019
- Subject who has not expressed his or her opposition, after information, to the reuse of his or her data for the purpose of this research
Who cannot join
- Subject who has expressed his/her opposition to participate in the study
- Subjects under guardianship, curatorship or legal protection, pregnant women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Réanimation Chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091
Antoine PONS, MD, 33 3 69 55 00 84, antoine.pons@chru-strasbourg.fr
Antoine PONS, MD
About this study
Opioid-free anesthesia is a new approach to anesthesia, described and used for many years. If it represents many advantages by reducing the side effects of morphine, its precise place in current practice and in terms of postoperative rehabilitation remains to be determined. Studies are not yet numerous enough to affirm a real benefit.
Obese patients are potentially able to benefit from the reduction in the use of morphine during surgery, in terms of quality of postoperative analgesia, side effects (respiratory depression, ileus, somnolence) and early rehabilitation.
- Conditions
- Severe Obesity
- Keywords
- Bariatric surgery, Opioid-free anesthesia, Non-opioid anesthesia, Severe obesity
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of morphine used intraoperatively
Measured: Intraoperative (during the operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start11 Feb 2020
- Primary completionDec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162416
- Sponsor's protocol ID
- 7645
- Acronym
- BARIA
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-opioid Anesthesia in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06162416
- Acronym / sponsor ID
- BARIA / 7645
- Conditions
- Severe Obesity
- Keywords
- Bariatric surgery, Opioid-free anesthesia, Non-opioid anesthesia, Severe obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Opioid-free anesthesia is a new approach to anesthesia, described and used for many years. If it represents many advantages by reducing the side effects of morphine, its precise place in current practice and in terms of postoperative rehabilitation remains to be determined. Studies are not yet numerous enough to affirm a real benefit.
Obese patients are potentially able to benefit from the reduction in the use of morphine during surgery, in terms of quality of postoperative analgesia, side effects (respiratory depression, ileus, somnolence) and early rehabilitation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥ 18 years old) who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019
Key inclusion criteria (3 listed)
- Major subject (≥ 18 years old),
- who have undergone bariatric surgery at the HUS between January 01, 2017 and December 31, 2019
- Subject who has not expressed his or her opposition, after information, to the reuse of his or her data for the purpose of this research
Key exclusion criteria (2 listed)
- Subject who has expressed his/her opposition to participate in the study
- Subjects under guardianship, curatorship or legal protection, pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dose of morphine used intraoperatively
Time frame: Intraoperative (during the operation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Obesity, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine PONS, MD (33 3 69 55 00 84, antoine.pons@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of morphine used intraoperatively (time frame: Intraoperative (during the operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.