Bariatric SurgeryNCT06981793
Predictors of Anesthesia Complications in Patients Undergoing Bariatric Surgery
An observational study of Bariatric Surgery and Anesthesia, General, run by Centre Hospitalier de Gonesse at 1 site in France.
Trial summary
This study aims to identify factors that can predict complications related to anesthesia in patients undergoing weight-loss surgery. By looking at patient data from past surgeries, we hope to better understand which factors increase the risk of anesthesia problems, helping doctors improve patient safety during these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Anesthesia, General, Postoperative Complications
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2023to 20 Jan 2024
- 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: The study participants will be selected from adult patients who underwent sleeve gastrectomy as part of bariatric surgery at the Gonesse Hospital (CHG) between January 1, 2020, and June 30, 2021.
Who may be able to join
- Adult patients (age ≥ 18 years)
- Patients who underwent a longitudinal gastrectomy (sleeve) between January 1, 2020, and June 30, 2021, at CHG, as part of bariatric surgery treatment.
Who cannot join
- Minor patients
- Patients who underwent a bariatric surgery other than sleeve gastrectomy
- Patients who objected to the use of their data for research purposes
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to identify factors that can predict complications related to anesthesia in patients undergoing weight-loss surgery. By looking at patient data from past surgeries, we hope to better understand which factors increase the risk of anesthesia problems, helping doctors improve patient safety during these procedures.
- Conditions
- Bariatric Surgery, Anesthesia, General, Postoperative Complications, Obesity, Risk Factors
- Medical subject headings
- Postoperative Complications, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Anesthesia-Related Complications in Bariatric Surgery Patients
The primary outcome of this study is to assess the occurrence of anesthesia-related complications in patients undergoing bariatric surgery, specifically sleeve gastrectomy. These complications include difficult intubation, bronchospasm, desaturation, abnormal heart rate (bradycardia or tachycardia), changes in blood pressure (hypotension or hypertension), nausea and vomiting, hypo or hyperglycemia, delayed awakening, and death. This measure will help identify factors that predict the likelihood of these complications, ultimately improving patient safety in bariatric surgery.
Measured: October 2023 - January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start20 Oct 2023
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Gonesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981793
- Sponsor's protocol ID
- 0050_ANESTHESIE
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Anesthesia Complications in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06981793
- Acronym / sponsor ID
- 0050_ANESTHESIE
- Conditions
- Bariatric Surgery, Anesthesia, General, Postoperative Complications, Obesity, Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Centre Hospitalier de GonesseUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 21 May 2025 (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.
This study aims to identify factors that can predict complications related to anesthesia in patients undergoing weight-loss surgery. By looking at patient data from past surgeries, we hope to better understand which factors increase the risk of anesthesia problems, helping doctors improve patient safety during these procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study participants will be selected from adult patients who underwent sleeve gastrectomy as part of bariatric surgery at the Gonesse Hospital (CHG) between January 1, 2020, and June 30, 2021.
Key inclusion criteria (2 listed)
- Adult patients (age ≥ 18 years)
- Patients who underwent a longitudinal gastrectomy (sleeve) between January 1, 2020, and June 30, 2021, at CHG, as part of bariatric surgery treatment.
Key exclusion criteria (3 listed)
- Minor patients
- Patients who underwent a bariatric surgery other than sleeve gastrectomy
- Patients who objected to the use of their data for research purposes
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
Occurrence of Anesthesia-Related Complications in Bariatric Surgery Patients
Time frame: October 2023 - January 2024
The primary outcome of this study is to assess the occurrence of anesthesia-related complications in patients undergoing bariatric surgery, specifically sleeve gastrectomy. These complications include difficult intubation, bronchospasm, desaturation, abnormal heart rate (bradycardia or tachycardia), changes in blood pressure (hypotension or hypertension), nausea and vomiting, hypo or hyperglycemia, delayed awakening, and death. This measure will help identify factors that predict the likelihood of these complications, ultimately improving patient safety in bariatric surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bariatric Surgery and Anesthesia, General, run by Centre Hospitalier de Gonesse 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Anesthesia-Related Complications in Bariatric Surgery Patients (time frame: October 2023 - January 2024). 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 21 May 2025.