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

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Delirium; Cerebral Hypoxia
• Intervention / Treatment: Drug: Sevoflurane; Drug: Propofol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Medical center of the Main Administration for Service to the Diplomatic Corps
    • Contact: Yuri V. Skripkin; Email: skripkin62@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sevoflurane; Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia	Drug: Sevoflurane; 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.; Other Names: Sevorane; Ultane; Fluoromethyl hexafluoroisopropyl ether
Active Comparator: Propofol; Propofol Based Total Intravenous Anesthesia	Drug: Propofol; 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.; Other Names: Diprivan; Propoven; Propolipid; Recofol; Lipuro; Unifol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Negovsky Reanimatology Research Institute
• Investigators: Study Chair: Valery V. Likhvantsev, MD, Prof., Negovsky Reanimatology Research Institute, Moscow, Russia; Study Director: Oleg A. Grebenchikov, MD, PhD, Negovsky Reanimatology Research Institute, Moscow, Russia; Principal Investigator: Yuri V. Iljin, Negovsky Reanimatology Research Institute, Moscow, Russia; Principal Investigator: Alexander V. Mironenko, MD, PhD, Negovsky Reanimatology Research Institute, Moscow, Russia; Principal Investigator: Yuri V. Skripkin, Negovsky Reanimatology Research Institute, Moscow, Russia; Principal Investigator: Dmitriy B. Selivanov, MD, PhD, Hospital Maria Vittoria, Turin, Italy

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 8, 2014

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 6, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Propofol; Sevoflurane; Delirium; Hypoxic Brain Damage; S100b protein
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Signs and Symptoms, Respiratory; Delirium; Hypoxia; Hypoxia, Brain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: Sev003; s100b (Other Identifier: s100b)