NCT02524327

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anesthesia, General
• Aged, 70 and Over

Interventions

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

Timeline

• Start date: 2015-07-07
• Primary completion: 2018-01-30
• Completion: 2018-01-30
• First posted: 2015-08-14
• Last updated: 2022-03-16

Locations

4 sites across 1 country: France