AzTrials
AzTrials

Anesthesia, GeneralFRAGILNCT02524327

Frail Status of Elderly Patients After Repair and Anesthesia Guided by the bispectraL Index

A study testing Toolbox: Automated group and Manual group in people with Anesthesia, General and Aged, 70 and Over, run by Hopital Foch at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The first aim of this study is to compare two methods of administration of intravenous anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual or automated and to determine a mid-term (6 months) influence of the frail phenotype on self-sufficient elderly patients after general… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Anesthesia, General, Aged, 70 and Over
What is being tested?
Toolbox: Automated group and Manual group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
4 sitesFrance
Study dates
7 Jul 2015to 30 Jan 2018
Phase
Interventional
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

Who may be able to join

  • Adult patients aged > 70 years old
  • American Society of Anesthesiologists class I to III
  • Scheduled for abdominal surgery under total intra-venous anesthesia
  • Self sufficient (living at home or in a non medical institution)
  • Written consent to the study

Who cannot join

  • Allergy to any intravenous agent (propofol or remifentanil)
  • Cognitive impairment with a Mini Mental State Examination < 20
  • Severe visual or hearing deficiency, apraxia
  • Restriction of the use of bispectral index

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Hopital Jean Minjoz

    Besançon, 25030

  • Institut Hopsitalier Franco-Britannique

    Levallois-Perret, 92300

  • Centre Clinical

    Soyaux, 16800

  • Hopital Foch

    Suresnes, 92150

Other trials in France

About this study

Official title: Influence of the Modality of General Anesthesia Guided by the Bispectral Index (Manual or Automated) on the Occurrence of a Loss of Capability in Elderly Patients (> 70 Yrs): a Randomized Multicenter Study

The first aim of this study is to compare two methods of administration of intravenous anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual or automated and to determine a mid-term (6 months) influence of the frail phenotype on self-sufficient elderly patients after general anesthesia.

Read the detailed description

To date, patients over the age of 60 yrs represent 25% of the population and are at increased risk of surgical repair. Reduction of postoperative morbidity and mortality are now two main concerns for medical research. Dependence on caregivers and cognitive impairments are two major risks in the elderly and even more in frail patients after surgery under general anesthesia. In this context continuous monitoring of the depth of anesthesia through bispectral index may reduce its occurrence with better control of too deep sedation periods (vasopressors…). Previous studies by the investigators' team suggest a better duration in the expected interval of Bispectral Index with automated control of administration of intravenous anesthetics guided by Bispectral Index. This method remains to be tested in this high-risk population. As a consequence, a randomization into two groups will be carried on elderly patients (> 70 yrs): manual administration of anesthetics guided by Bispectral Index (manual group) or automated administration (automated group). Complete preoperative assessments will determine the FRAIL status (with a decrease in the physiological reserve) and abilities of the patient according to the self-sufficient scale. At six months a follow-up will determine the geriatric status of the patient to explore the rate of impairment and to examine predictive factors in the preoperative assessment. Finally, the influence of the method of administration will be reported. Four hundred and thirty patients will be included in this multicenter study with 215 patients per group and stratification of the presence of a cancer and of the abdominal repair. The follow-up in this study allows the patient or his/her relatives to keep in touch with a physician and to prescribe some therapy early if frailty or any other cognitive impairment appears.

Being tested
Toolbox: Automated group, Manual group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Toolbox: Automated groupOther

    Also called controller

    A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index

  • Manual groupOther

    The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index

Study groups in NCT02524327
Study groupRoleWhat they receive
Toolbox: Automated groupExperimentalToolbox: Automated administration of intravenous anesthetic (propofol 1%) and analgesic (remifentanil, Ultiva(r)) guided by the Bispectral index through a controller with a previously described algorithm. Objective of depth anesthesia: 40-60
Receives: Other: Toolbox: Automated group
Manual groupActive comparatorManual administration of intravenous anesthetic (propofol 1%) and analgesic (remifentanil, Ultiva(r)) guided by the Bispectral index as usually performed in the operative theater. Objective of depth anesthesia: 40-60
Receives: Other: Manual group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients without occurrence of disability according to the InterRai scale

    Disability is evaluated using the InterRai scale; a death is considered as an irreversible disability institutionalization is considered as a severe disability InterRai scale would discriminate other patients

    Measured: 6 months

Secondary outcomes (13)

  1. Mortality at day 28

    Measured: 28 days

  2. Mortality at month 6

    Measured: 6 months

  3. Rate of postoperative cognitive dysfunction

    Cognitive dysfunction is evaluated using the Mini Mental State examination

    Measured: 6 months

  4. Incidence of pneumopathy

    Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics

    Measured: 6 months

  5. Incidence of pulmonary embolism

    Diagnosis on CT-scan with contrast injection

    Measured: 6 months

  6. Incidence of postoperative myocardial infarction

    EKG modification and raised troponin

    Measured: 6 months

  7. Incidence of evolution of the frail phenotype

    Frail phenotype accordingly to Fried Scale

    Measured: 6 months

  8. Quality of the general anesthesia

    Defined as the time with a Bispectral Index in the interval 40-60

    Measured: 1 day

  9. Performance of the automated system

    Defined according to the Varvell score

    Measured: 1 day

  10. Presence of Suppression Ratio

    Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute

    Measured: 1 day

  11. Occurrence of arterial hypotension requiring treatment

    Defined as a drop of 20% or more of the mean arterial pressure compared to the basal value measured before anesthetic induction and the requirement for a vasoactive agent

    Measured: 1 day

  12. Patients'satisfaction about general anesthesia

    Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment)

    Measured: 1 day

  13. Occurrence of awareness

    Postoperative specific questionnaire

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2015 (estimated)
  2. Study start7 Jul 2015
  3. Primary completion30 Jan 2018
  4. Study completion30 Jan 2018

Why it stopped: Material issues. Re-start in assessment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02524327
Sponsor's protocol ID
2014/28
Other IDs
2014-A01270-47
Acronym
FRAGIL
Status last verified
Mar 2022
First submitted
10 Aug 2015
Last updated
16 Mar 2022
Results posted
No
Data monitoring committee
No

Publications

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156

  • Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

    PubMed 21233500

  • Le Guen M, Herr M, Bizard A, Bichon C, Boichut N, Chazot T, Liu N, Ankri J, Fischler M. Frailty Related to Anesthesia guided by the Index "bispectraL" (FRAIL) study: study protocol for a randomized controlled trial. Trials. 2017 Mar 16;18(1):127. doi: 10.1186/s13063-017-1868-9.

    PubMed 28298244

Questions about this trial

What is this clinical trial studying?

A study testing Toolbox: Automated group and Manual group in people with Anesthesia, General and Aged, 70 and Over, run by Hopital Foch at 4 sites 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 4 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: stopped early, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 was stopped early (reason given: Material issues. Re-start in assessment). Results are not available in the source record.

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?

Rate of patients without occurrence of disability according to the InterRai scale (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02524327, which also lists 3 linked publications.

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 16 Mar 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in