Preoperative Fasting and HypotensionJEÛNE PREOPNCT02891122
Effect of the Duration of Preoperative Fasting on Hypotension Induced by General Anesthesia in the Elderly Person
An observational study of Preoperative Fasting and Hypotension, run by University Hospital, Brest at 1 site in France.
Trial summary
This study aims to determine if prolonged fasting represents an independent risk factor for hypotension during induction of general anesthesia in the elderly. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Preoperative Fasting and Hypotension
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Jul 2015
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients hospitalized for fracture of the proximal femur requiring surgical treatment
Who may be able to join
- Risk Score anesthetic ASA I-III
- Patients ≥ 70 years
- Suffering from a femoral neck fracture to be treated surgically:
- either through prosthesis,
- either by intramedullary nailing (gamma nail)
Who cannot join
- Risk Score anesthetic ASA IV
- Patient on Angiotensin Converting Enzyme (ACE) inhibitors or ARBs (ARA2) within 10 hours before surgery
- Obesity (BMI> 35) or weight <40kg
- Need to make a rapid sequence induction
- Inability to achieve the femoral block (standardization of induction) or patient refusal with respect to the technique.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Duration of Fluid Abstinence on Hypotension During General Anaesthesia Induction for Traumatic Hip Surgery in the Elderly
This study aims to determine if prolonged fasting represents an independent risk factor for hypotension during induction of general anesthesia in the elderly.
Read the detailed description
Preoperative fasting aims to reduce the risk of adverse events (eg, inhalation), but may be responsible for dehydration whose consequence is a major hypotension. This problem of hypotension is important because it (MAP <55 mmHg) is directly correlated to the occurrence of pejorative events on the cardiac and renal level and even more so that the duration of the hypotension is long.
- Conditions
- Preoperative Fasting and Hypotension
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up of the variation of the Mean arterial pressure
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Fasting and HypotensionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Lafère, Doctor, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891122
- Sponsor's protocol ID
- JEÛNE PREOPERATOIRE
- Acronym
- JEÛNE PREOP
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Duration of Fluid Abstinence on Hypotension During General Anaesthesia Induction for Traumatic Hip Surgery in the Elderly
- ClinicalTrials.gov ID
- NCT02891122
- Acronym / sponsor ID
- JEÛNE PREOP / JEÛNE PREOPERATOIRE
- Conditions
- Preoperative Fasting and Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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 determine if prolonged fasting represents an independent risk factor for hypotension during induction of general anesthesia in the elderly.
Detailed description
Preoperative fasting aims to reduce the risk of adverse events (eg, inhalation), but may be responsible for dehydration whose consequence is a major hypotension. This problem of hypotension is important because it (MAP <55 mmHg) is directly correlated to the occurrence of pejorative events on the cardiac and renal level and even more so that the duration of the hypotension is long.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients hospitalized for fracture of the proximal femur requiring surgical treatment
Key inclusion criteria (5 listed)
- Risk Score anesthetic ASA I-III
- Patients ≥ 70 years
- Suffering from a femoral neck fracture to be treated surgically:
Key exclusion criteria (5 listed)
- Risk Score anesthetic ASA IV
- Patient on Angiotensin Converting Enzyme (ACE) inhibitors or ARBs (ARA2) within 10 hours before surgery
- Obesity (BMI> 35) or weight <40kg
- Need to make a rapid sequence induction
- Inability to achieve the femoral block (standardization of induction) or patient refusal with respect to the technique.
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
Follow-up of the variation of the Mean arterial pressure
Time frame: 8 months
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 7 Sep 2016.
Related trials for Preoperative Fasting and Hypotension
RecruitingObservational study
The Million Anesthesia Cases Study (MACS) - a Cohort Study of Preoperative Fasting and Perioperative Outcomes
Anesthesia, Sedation
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.
Pierre Lafère, Doctor principal investigator
CHRU de Brest
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 Preoperative Fasting and Hypotension, run by University Hospital, Brest 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 5 inclusion and 5 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 7 Sep 2016. 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?
Follow-up of the variation of the Mean arterial pressure (time frame: 8 months). 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 7 Sep 2016.