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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02524327
Other study ID # 2014/28
Secondary ID 2014-A01270-47
Status Terminated
Phase N/A
First received
Last updated
Start date July 7, 2015
Est. completion date January 30, 2018

Study information

Verified date March 2022
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 anesthesia.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 134
Est. completion date January 30, 2018
Est. primary completion date January 30, 2018
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Toolbox: Automated group
A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index
Manual group
The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index

Locations

Country Name City State
France Hopital Jean Minjoz Besançon
France Institut Hopsitalier Franco-Britannique Levallois-Perret
France Centre Clinical Soyaux
France Hopital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mortality at day 28 28 days
Secondary Mortality at month 6 6 months
Secondary Rate of postoperative cognitive dysfunction Cognitive dysfunction is evaluated using the Mini Mental State examination 6 months
Secondary Incidence of pneumopathy Defined as a septic syndrome (fever) + increased number of polynuclear cells + typical image on chest X-ray + treatment with antibiotics 6 months
Secondary Incidence of pulmonary embolism Diagnosis on CT-scan with contrast injection 6 months
Secondary Incidence of postoperative myocardial infarction EKG modification and raised troponin 6 months
Secondary Incidence of evolution of the frail phenotype Frail phenotype accordingly to Fried Scale 6 months
Secondary Quality of the general anesthesia Defined as the time with a Bispectral Index in the interval 40-60 1 day
Secondary Performance of the automated system Defined according to the Varvell score 1 day
Secondary Presence of Suppression Ratio Defined as a period of isoelectric cortical signal with a threshold at 10% for 1 minute 1 day
Secondary 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 1 day
Secondary Patients'satisfaction about general anesthesia Evaluation using a numeric scale from 0 (the worst remembrance) to 10 (an excellent moment) 1 day
Secondary Occurrence of awareness Postoperative specific questionnaire 3 months
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