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NCT Number: NCT01282086

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

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.

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Key information

Conditions

Anesthesia, General

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Ref # / Investigator 49151, Dnipropetrovsk, Ukraine

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to Loss of Consciousness of Patients Administered Anesthesia

    Time frame: Up to 16 minutes

    Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.

  2. Time to Awakening of Patients

    Time frame: Every minute after anesthesia was stopped until the patient responded to a verbal command

    Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.

  3. Time to Extubation of Patients

    Time frame: Every minute after anesthesia was stopped until extubation occurred

    Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.

  4. Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia

    Time frame: Day 1

    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).

  5. Patients' Overall Impression of the Anesthesia With Sevorane

    Time frame: Day 1

    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 outcomes

  1. Systolic Blood Pressure

    Time frame: Before starting anesthesia to one hour after the operation

    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.

  2. Diastolic Blood Pressure

    Time frame: Before starting anesthesia to one hour after the operation

    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.

  3. Mean Arterial Pressure

    Time frame: Before starting anesthesia to one hour after the operation

    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.

  4. Heart Rate

    Time frame: Before starting anesthesia to one hour after the operation

    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.

  5. Presence of Deviations in Electrocardiogram Assessments During Anesthesia

    Time frame: During induction and maintenance of anesthesia on Day 1

    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).

  6. Cardiac Troponin (Troponin T) (if Available)

    Time frame: Within 24 hours after anesthesia

    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.

  7. Creatine Kinase Myocardial Isoenzyme (if Available)

    Time frame: Within 24 hours after anesthesia

    Creatine kinase myocardial isoenzyme (CK-MB) values measured within 24 hours of anesthesia were to be collected when available.

  8. Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia

    Time frame: Before starting anesthesia to one hour after the operation

    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.

  9. 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.

    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.

Sponsors and collaborators

Lead sponsor

Abbott (Ukraine)

Industry

Registry information

Official study 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)

Acronym: SEVOPROTECTION

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 24, 2011
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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