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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-06-30

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.

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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.

Conditions

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Cerebral Hypoxia Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sevoflurane

Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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.

Propofol

Propofol Based Total Intravenous Anesthesia

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Sevorane Ultane Fluoromethyl hexafluoroisopropyl ether Diprivan Lipuro Propolipid Propoven Recofol Unifol

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR