Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Requiring General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on the Cardiovascular System in Common Clinical Practice (SEVOPROTECTION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( Abbott (Ukraine) )
ClinicalTrials.gov Identifier:
NCT01282086
First received: January 21, 2011
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

The main objective of this post-marketing observational study (PMOS) is to collect data of using general anesthesia in patients undergoing any surgery to create local recommendations. These data will be based on the evaluation of volatile induction and maintenance anesthesia (VIMA) with Sevorane® (sevoflurane) in adult patients requiring general anesthesia for surgery in terms of quality of anesthesia and its influence on the cardiovascular system in common clinical practice in Ukraine.


Condition
Anesthesia, General

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of VIMA With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice (SEVOPROTECTION)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Time to Loss of Consciousness of Patients Administered Anesthesia [ Time Frame: Up to 16 minutes ] [ Designated as safety issue: No ]
    Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.

  • Time to Awakening of Patients [ Time Frame: Every minute after anesthesia was stopped until the patient responded to a verbal command ] [ Designated as safety issue: No ]
    Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.

  • Time to Extubation of Patients [ Time Frame: Every minute after anesthesia was stopped until extubation occurred ] [ Designated as safety issue: No ]
    Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.

  • Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The anesthesiologist's overall satisfaction with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).

  • Patients' Overall Impression of the Anesthesia With Sevorane [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: excellent, positive, indifferent, or other.


Secondary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: Before starting anesthesia to one hour after the operation ] [ Designated as safety issue: No ]
    The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.

  • Diastolic Blood Pressure [ Time Frame: Before starting anesthesia to one hour after the operation ] [ Designated as safety issue: No ]
    The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.

  • Mean Arterial Pressure [ Time Frame: Before starting anesthesia to one hour after the operation ] [ Designated as safety issue: No ]
    The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.

  • Heart Rate [ Time Frame: Before starting anesthesia to one hour after the operation ] [ Designated as safety issue: No ]
    The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.

  • Presence of Deviations in Electrocardiogram Assessments During Anesthesia [ Time Frame: During induction and maintenance of anesthesia on Day 1 ] [ Designated as safety issue: No ]
    Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).

  • Cardiac Troponin (Troponin T) (if Available) [ Time Frame: Within 24 hours after anesthesia ] [ Designated as safety issue: No ]
    Troponin T values measured within 24 hours of anesthesia were to be collected when available. No data were reported for this outcome measure during the study.

  • Creatine Kinase Myocardial Isoenzyme (if Available) [ Time Frame: Within 24 hours after anesthesia ] [ Designated as safety issue: No ]
    Creatine kinase myocardial isoenzyme (CK-MB) values measured within 24 hours of anesthesia were to be collected when available.

  • Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia [ Time Frame: Before starting anesthesia to one hour after the operation ] [ Designated as safety issue: No ]
    The anesthesiologists' length of clinical experience with Sevorane was collected. The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 (1 hour after the operation), and the minimum and maximum values, respectively.

  • Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening [ Time Frame: Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command. ] [ Designated as safety issue: No ]
    Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected. The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience (exp) with inhalation (inh) anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.


Enrollment: 1365
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adults requiring anesthesia for surgery
Adult patients requiring general anesthesia for surgery

Detailed Description:

This PMOS will be conducted in a prospective, multi-centre format. It is a non-interventional, observational study in which Sevorane is prescribed for adult patients undergoing general surgery for induction and maintenance of anesthesia in the usual manner in accordance with the terms of the local marketing authorization. Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist. No additional procedures (other than standard of care) shall be applied to the patients. Each patient will be observed from the starting of anesthesia till the anesthesia end. Markers of myocardial ischemia will be detected up to the first 24 hours after anesthesia (if available). Additionally the correlation between the experience and training background of anesthesiologists and patient related outcomes of general anesthesia with sevoflurane as a single anesthetic will be assessed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing planned or urgent surgery

Criteria

Inclusion Criteria:

  • Patients needing general anesthesia for planned or urgent surgery for whom Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist

Exclusion Criteria:

  • Known sensitivity to sevoflurane or other anesthetic containing halogen
  • Known or suspected genetic susceptibility to malignant hyperthermia
  • Receiving regional anesthetic techniques
  • Receiving intravenous anesthesia
  • A history of unexplained moderate/severe hepatic dysfunction with jaundice, fever, and/or eosinophilia in association with halogenated anesthetics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282086

Locations
Ukraine
Site Ref # / Investigator 49151
Dnipropetrovsk, Ukraine, 49005
Site Ref # / Investigator 49142
Kharkiv, Ukraine, 61018
Site Ref # / Investigator 52986
Kyiv, Ukraine, 01014
Site Ref # / Investigator 49144
Kyiv, Ukraine, 02660
Site Ref # / Investigator 49145
Kyiv, Ukraine, 03680
Site Ref # / Investigator 44445
Kyiv, Ukraine, 01133
Site Ref # / Investigator 49146
Lviv, Ukraine, 79010
Site Ref # / Investigator 49154
Mykolaiv, Ukraine, 54058
Site Ref # / Investigator 49148
Odesa, Ukraine, 65025
Site Ref # / Investigator 49152
Zaporizhia, Ukraine, 69600
Sponsors and Collaborators
Abbott (Ukraine)
Investigators
Study Director: Irina Magdik, MD, PhD, MBA Abbott Laboratories S.A., Ukraine
  More Information

No publications provided

Responsible Party: AbbVie ( Abbott (Ukraine) )
ClinicalTrials.gov Identifier: NCT01282086     History of Changes
Other Study ID Numbers: P12-637
Study First Received: January 21, 2011
Results First Received: December 7, 2012
Last Updated: January 4, 2013
Health Authority: Ukraine: Ministry of Health
Ukraine: Ethics Committee

Keywords provided by AbbVie:
Sevorane
Sevoflurane
General anesthesia
Inhalation anesthesia
General surgery

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on April 16, 2014