NCT02524327

Brief 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 anesthesia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

2.6 years

First QC Date

August 10, 2015

Last Update Submit

March 15, 2022

Conditions

Anesthesia, GeneralAged, 70 and Over

Outcome Measures

Primary Outcomes (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

    6 months

Secondary Outcomes (13)

  • Mortality at day 28

    28 days

  • Mortality at month 6

    6 months

  • Rate of postoperative cognitive dysfunction

    6 months

  • Incidence of pneumopathy

    6 months

  • Incidence of pulmonary embolism

    6 months

  • +8 more secondary outcomes

Study Arms (2)

Toolbox: Automated group

EXPERIMENTAL

Toolbox: 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

Other: Toolbox: Automated group

Manual group

ACTIVE COMPARATOR

Manual 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

Other: Manual group

Interventions

Toolbox: Automated groupOTHER

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

Also known as: controller
Toolbox: Automated group
Manual groupOTHER

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

Manual group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Jean Minjoz

Besançon, 25030, France

Location

Institut Hopsitalier Franco-Britannique

Levallois-Perret, 92300, France

Location

Centre Clinical

Soyaux, 16800, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (3)

  • 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.

    PMID: 11253156BACKGROUND

  • 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.

    PMID: 21233500BACKGROUND

  • 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.

    PMID: 28298244DERIVED

MeSH Terms

Interventions

CDK13 protein, human

Study Officials

  • Morgan Le Guen, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 14, 2015

Study Start

July 7, 2015

Primary Completion

January 30, 2018

Study Completion

January 30, 2018

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

FR(4)