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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2017 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT02524327
First received: August 10, 2015
Last updated: May 18, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Anesthesia, General
Aged, 70 and Over
Other: Toolbox: Automated group
Other: Manual group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Rate of patients without occurrence of disability according to the InterRai scale [ Time Frame: 6 months ]
    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


Secondary Outcome Measures:
  • Mortality at day 28 [ Time Frame: 28 days ]
  • Mortality at month 6 [ Time Frame: 6 months ]
  • Rate of postoperative cognitive dysfunction [ Time Frame: 6 months ]
    Cognitive dysfunction is evaluated using the Mini Mental State examination

  • Incidence of pneumopathy [ Time Frame: 6 months ]
    Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics

  • Incidence of pulmonary embolism [ Time Frame: 6 months ]
    Diagnosis on CT-scan with contrast injection

  • Incidence of postoperative myocardial infarction [ Time Frame: 6 months ]
    EKG modification and raised troponin

  • Incidence of evolution of the frail phenotype [ Time Frame: 6 months ]
    Frail phenotype accordingly to Fried Scale

  • Quality of the general anesthesia [ Time Frame: 1 day ]
    Defined as the time with a Bispectral Index in the interval 40-60

  • Performance of the automated system [ Time Frame: 1 day ]
    Defined according to the Varvell score

  • Presence of Suppression Ratio [ Time Frame: 1 day ]
    Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute

  • Occurrence of arterial hypotension requiring treatment [ Time Frame: 1 day ]
    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

  • Patients'satisfaction about general anesthesia [ Time Frame: 1 day ]
    Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment)

  • Occurrence of awareness [ Time Frame: 3 months ]
    Postoperative specific questionnaire


Estimated Enrollment: 430
Study Start Date: July 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toolbox: Automated group

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
A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index
Other Name: controller
Active Comparator: Manual group

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

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.
  Eligibility

Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02524327

Contacts
Contact: Morgan Le Guen, MD m.leguen@hopital-foch.org

Locations
France
Hopital Jean Minjoz Not yet recruiting
Besançon, France, 25030
Contact: Nathalie Boichut, MD         
Principal Investigator: Nathalie Boichut, MD         
Institut Hopsitalier Franco-Britannique Not yet recruiting
Levallois-Perret, France, 92300
Contact: Marc Solier, MD         
Principal Investigator: Marc Solier, MD         
Centre Clinical Not yet recruiting
Soyaux, France, 16800
Contact: Xavier Paqueron, MD         
Principal Investigator: Xavier Paqueron, MD         
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Marc Fischler, MD    0609687854    m.fischler@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Morgan Le Guen, MD Hopital Foch