Trial | NCT02133638  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    130
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.
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 Started
May 31
2014
Primary Completion
May 31
2015
Anticipated
Study Completion
Jun 30
2015
Anticipated
Last Update
May 08
2014
Estimate

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

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, Lipuro, Propolipid, Propoven, Recofol, Unifol

Sevoflurane Active Comparator

Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia

Propofol Active Comparator

Propofol Based Total Intravenous Anesthesia

Criteria 

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
No Results Posted