Early post-operative cognitive dysfunction after closed-loop versus manual target controlled-infusion of propofol and remifentanil in patients undergoing elective major non-cardiac surgery

Abstract

Introduction:Post-operative cognitive dysfunction (POCD) is frequent in patients older than 60 years undergoing major non-cardiac surgery, and increases both morbidity and mortality. Anesthetic drugs may exert neurotoxic effects and contribute to the genesis of POCD. The hypothesis of the POCD-ELA trial was that closed-loop target-controlled infusion of propofol and remifentanil could reduce the occurrence of POCD by decreasing the risk of excessive depth of anesthesia and the dose of anesthetic drugs.Methods and analysis:We designed a single-center, single-blind, randomized, controlled, parallel trial and aim to include 204 patients aged >60 years undergoing elective major non-cardiac surgery. Patients will be randomized to receive closed-loop versus manual target-controlled infusion of propofol and remifentanil guided by bispectral index monitoring. Cognitive assessment will be performed the day before surgery (baseline) and within 72 hours after surgery, using a battery of validated neuropsychological tests. The primary outcome is the incidence of POCD within 72 hours after surgery. POCD is defined as a Z-score value > 1.96 for at least 2 different tests or a Z-score composite value >1.96. The calculation of the Z-score is based on data from an age-matched control population who did not undergo surgery or general anesthesia.Ethics and dissemination:This study was approved by the Ethics Committee (Comité de Protection des Personnes Est-II) and authorized by the French Health Products Agency (Agence Nationale de Sécurité des Médicaments, Saint-Denis, France). The University Hospital of Besancon is the trial sponsor and the holder of all data and publication rights. Results of the study will be submitted for publication in a peer-review international medical journal and for presentation in abstract (oral or poster) in international peer-reviewed congresses.Registration:The trial is registered with ClinicalTrials.gov (Identifier: NCT02841423, principal investigator: Prof Emmanuel Samain, date of registration: July 22, 2016). Last amendment of protocol: version 8.0 April 2018.

Nonoperating room anesthesia education

“…DOH systems may also be combined with closed-loop delivery anesthesia systems to modulate anesthetic delivery. [23,24]. In the future, residents will have to understand the attributes and limitations of DOH monitoring devices, understand the theory behind target-controlled infusions and closed-loop infusion systems, and be comfortable using all of them.…”

Electric vagal nerve stimulation inhibits inflammation and improves early postoperation cognitive dysfunction in aged rats

“…Fourteen percent of patients have been found cognitive decline and confusion after surgery with anesthesia [1, 2]. POCD is frequent in patients older than 60-year undergoing major non-cardiac surgery, which increases both morbidity and mortality [3]. These cognitive impairments are related to language comprehension, attention, social integration and short term memory.…”

Electric vagal nerve stimulation inhibits inflammation and improves early postoperation cognitive dysfunction in aged rats

“…Fourteen percent of patients have been found cognitive decline and confusion after surgery with anesthesia [1,2]. POCD is frequent in patients older than 60-year undergoing major noncardiac surgery, which increases both morbidity and mortality [3]. These cognitive impairments are related to language comprehension, attention, social integration and short term memory.…”