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

N/ACompletedNCT01282086

Abbott (Ukraine)1,365 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,365

Conditions

Anesthesia, General

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Site Ref # / Investigator 49151

Dnipropetrovsk, Ukraine

Site Ref # / Investigator 49142

Kharkiv, Ukraine

Site Ref # / Investigator 52986

Kyiv, Ukraine

Site Ref # / Investigator 44445

Kyiv, Ukraine

Site Ref # / Investigator 49144

Kyiv, Ukraine

Site Ref # / Investigator 49145

Kyiv, Ukraine

Site Ref # / Investigator 49146

Lviv, Ukraine

Site Ref # / Investigator 49154

Mykolaiv, Ukraine

Site Ref # / Investigator 49148

Odesa, Ukraine

Site Ref # / Investigator 49152

Zaporizhia, Ukraine

Outcomes

Primary Outcomes

Time to Loss of Consciousness of Patients Administered Anesthesia

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

Time frame: Up to 16 minutes

Time to Awakening of Patients

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

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

Time to Extubation of Patients

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

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

Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia

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).

Time frame: Day 1

Patients' Overall Impression of the Anesthesia With Sevorane

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.

Time frame: Day 1

Secondary Outcomes

Systolic Blood Pressure

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.

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

Diastolic Blood Pressure

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.

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

Mean Arterial Pressure

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.

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

Heart Rate

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.

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

Presence of Deviations in Electrocardiogram Assessments During Anesthesia

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).

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

Cardiac Troponin (Troponin T) (if Available)

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.

Time frame: Within 24 hours after anesthesia

Creatine Kinase Myocardial Isoenzyme (if Available)

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

Time frame: Within 24 hours after anesthesia

Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia

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.

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

Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening

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.

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