Sevoflurane Decreases the Risk of Postoperative Delirium After Cerebral Hypoxemia During Surgery

Study Overview
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Brief Summary
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The aim of this study is to distinguish possible differences in frequency of delirium after Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of undeliberate cerebral desaturation during non-cardiac surgery.

Detailed Description
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The aim of the present study is to investigate whether in non-cardiac surgery the frequency of POD after intraoperative undeliberate cerebral saturation could be modulated by the choice of the anesthetic strategy (Volatile Induction and Maintenance of Anesthesia [VIMA] and Total Intravenous Anesthesia [TIVA]). Based on our previous data we hypothesized that incidence of POD would be lower with VIMA compared to TIVA.

Official Title
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Sevoflurane-based Volatile Induction and Maintenance of Anaesthesia (VIMA) Strategy Decreases the Risk of Postoperative Delirium in Elderly Patients With Registered Cerebral Hypoxemia Episodes During General Surgery

Conditions
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Cerebral Hypoxia, Postoperative Delirium

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: class III-IV by physical status classification system of American Society of Anesthesiologist (ASA) history of arterial vascular disease (arterial hypertension, myocardial ischemia and/or cerebral vascular disease) undergoing elective non-cardiac surgery (hemicolectomy, hernioplasty, laparoscopic cholecystectomy and laparoscopic hysterectomy) Exclusion Criteria: dementia stroke or myocardial infarction ≤ 6 months before surgery oncological disease of T2-4N3M1 stage

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sevoflurane<br>Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia | Drug: Sevoflurane<br>* Induction of anesthesia: fentanyl 2 µg kg-1 and a bolus inhalation of 8% sevoflurane in an 8 L.min-1 fresh gas flow. Anesthesia maintenance: 1 minimal alveolar concentration (MAC) sevoflurane at a low fresh gas flow of 0.6-0.8 L min-1 in a 60% air-oxygen mixture supplemented with boluses of fentanyl.<br>* Other names: Fluoromethyl hexafluoroisopropyl ether;|
| Active Comparator: Propofol<br>Propofol Based Total Intravenous Anesthesia | Drug: Propofol<br>* Induction of anesthesia: propofol 2 mg kg-1 and fentanyl 4 µg kg-1. Maintenance of anesthesia: infusion of propofol 8 mg kg-1 h-1 and boluses of fentanyl 3 µg kg-1.<br>* Other names: Unifol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regional Cerebral Oxygenation (rSO2) |  | Continued the entire surgery | 
| Peripheral tissue oxygen saturation (SpO2) |  | Continued the entire surgery | 
| Non-invasive blood pressure (NIBP) |  | Continued the entire surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Incidences of postoperative delirium (POD) | Applying the Confusion Assessment Method for the ICU (CAM-ICU) | Baseline, 24h and 48h after surgery | 
| Plasma concentration of S100b protein | S100b protein is the neuronal injury marker | Baseline, 24h and 48h after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Hypoxic Brain Damage, Propofol, S100b protein, Sevoflurane