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

NCT02133638 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2014-05-08

No results posted yet for this study

Summary

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.

Conditions

  • Cerebral Hypoxia
  • Postoperative Delirium

Interventions

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.

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.

Sponsors & Collaborators

  • Negovsky Reanimatology Research Institute

    lead OTHER_GOV

Principal Investigators

  • Valery V. Likhvantsev, MD, Prof. · Negovsky Reanimatology Research Institute, Moscow, Russia

  • Oleg A. Grebenchikov, MD, PhD · Negovsky Reanimatology Research Institute, Moscow, Russia

  • Yuri V. Iljin · Negovsky Reanimatology Research Institute, Moscow, Russia

  • Alexander V. Mironenko, MD, PhD · Negovsky Reanimatology Research Institute, Moscow, Russia

  • Yuri V. Skripkin · Negovsky Reanimatology Research Institute, Moscow, Russia

  • Dmitriy B. Selivanov, MD, PhD · Hospital Maria Vittoria, Turin, Italy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02133638 on ClinicalTrials.gov