NCT02133638

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 6, 2014

Last Update Submit

May 6, 2014

Conditions

Cerebral HypoxiaPostoperative Delirium

Keywords

DeliriumHypoxic Brain DamagePropofolS100b proteinSevoflurane

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Number of Incidences of postoperative delirium (POD)

    Baseline, 24h and 48h after surgery

  • Plasma concentration of S100b protein

    Baseline, 24h and 48h after surgery

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia

Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

Propofol Based Total Intravenous Anesthesia

Drug: Propofol

Interventions

SevofluraneDRUG

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.

Also known as: Sevorane, Ultane, Fluoromethyl hexafluoroisopropyl ether
Sevoflurane
PropofolDRUG

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.

Also known as: Diprivan, Lipuro, Propolipid, Propoven, Recofol, Unifol
Propofol

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • dementia
  • stroke or myocardial infarction ≤ 6 months before surgery
  • oncological disease of T2-4N3M1 stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical center of the Main Administration for Service to the Diplomatic Corps

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Hypoxia, BrainEmergence DeliriumDelirium

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsConfusionNeurobehavioral ManifestationsNeurologic ManifestationsPostoperative ComplicationsPathologic ProcessesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Valery V. Likhvantsev, MD, Prof.

    Negovsky Reanimatology Research Institute, Moscow, Russia

    STUDY CHAIR

  • Oleg A. Grebenchikov, MD, PhD

    Negovsky Reanimatology Research Institute, Moscow, Russia

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valery V. Likhvantsev, MD, Prof.

CONTACT

lik0704@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

RU(1)