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

Primary Purpose

Cerebral Hypoxia, Postoperative Delirium

Status

Unknown status

Phase

Phase 4

Locations

Russian Federation

Study Type

Interventional

Intervention

Sevoflurane

Propofol

About this trial

This is an interventional prevention trial for Cerebral Hypoxia focused on measuring Delirium, Hypoxic Brain Damage, Propofol, S100b protein, Sevoflurane

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Sevoflurane

Propofol

Arm Description

Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia

Propofol Based Total Intravenous Anesthesia

Outcomes

Primary Outcome Measures

Regional Cerebral Oxygenation (rSO2)

Peripheral tissue oxygen saturation (SpO2)

Non-invasive blood pressure (NIBP)

Secondary Outcome Measures

Number of Incidences of postoperative delirium (POD)

Applying the Confusion Assessment Method for the ICU (CAM-ICU)

Plasma concentration of S100b protein

S100b protein is the neuronal injury marker

Full Information

NCT ID

NCT02133638

First Posted

May 6, 2014

Last Updated

May 6, 2014

Sponsor

Negovsky Reanimatology Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02133638

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2014 (undefined)

Primary Completion Date

May 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Negovsky Reanimatology Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Hypoxia, Postoperative Delirium

Keywords

Delirium, Hypoxic Brain Damage, Propofol, S100b protein, Sevoflurane

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sevoflurane

Arm Type

Active Comparator

Arm Description

Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia

Arm Title

Propofol

Arm Type

Active Comparator

Arm Description

Propofol Based Total Intravenous Anesthesia

Intervention Type

Drug

Intervention Name(s)

Sevoflurane

Other Intervention Name(s)

Sevorane, Ultane, Fluoromethyl hexafluoroisopropyl ether

Intervention Description

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

Intervention Name(s)

Propofol

Other Intervention Name(s)

Diprivan, Lipuro, Propolipid, Propoven, Recofol, Unifol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Regional Cerebral Oxygenation (rSO2)

Time Frame

Continued the entire surgery

Title

Peripheral tissue oxygen saturation (SpO2)

Time Frame

Continued the entire surgery

Title

Non-invasive blood pressure (NIBP)

Time Frame

Continued the entire surgery

Secondary Outcome Measure Information:

Title

Number of Incidences of postoperative delirium (POD)

Description

Applying the Confusion Assessment Method for the ICU (CAM-ICU)

Time Frame

Baseline, 24h and 48h after surgery

Title

Plasma concentration of S100b protein

Description

S100b protein is the neuronal injury marker

Time Frame

Baseline, 24h and 48h after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valery V. Likhvantsev, MD, Prof.

lik0704@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valery V. Likhvantsev, MD, Prof.

Organizational Affiliation

Negovsky Reanimatology Research Institute, Moscow, Russia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Oleg A. Grebenchikov, MD, PhD

Organizational Affiliation

Negovsky Reanimatology Research Institute, Moscow, Russia

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yuri V. Iljin

Organizational Affiliation

Negovsky Reanimatology Research Institute, Moscow, Russia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alexander V. Mironenko, MD, PhD

Organizational Affiliation

Negovsky Reanimatology Research Institute, Moscow, Russia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yuri V. Skripkin

Organizational Affiliation

Negovsky Reanimatology Research Institute, Moscow, Russia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dmitriy B. Selivanov, MD, PhD

Organizational Affiliation

Hospital Maria Vittoria, Turin, Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Moscow

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuri V. Skripkin

skripkin62@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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