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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02524327
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : September 20, 2017
Information provided by (Responsible Party):
Hopital Foch

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.

Condition or disease Intervention/treatment Phase
Anesthesia, General Aged, 70 and Over Other: Toolbox: Automated group Other: Manual group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Actual Study Start Date : July 7, 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Mortality at day 28 [ Time Frame: 28 days ]
  2. Mortality at month 6 [ Time Frame: 6 months ]
  3. Rate of postoperative cognitive dysfunction [ Time Frame: 6 months ]
    Cognitive dysfunction is evaluated using the Mini Mental State examination

  4. 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

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

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

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

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

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

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

  11. 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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02524327

Contact: Morgan Le Guen, MD

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   
Sponsors and Collaborators
Hopital Foch
Principal Investigator: Morgan Le Guen, MD Hopital Foch