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)

• ClinicalTrials.gov Identifier: NCT01282086
• Recruitment Status: Completed
• First Posted: January 24, 2011
• Results First Posted: February 4, 2013
• Last Update Posted: February 4, 2013
• Sponsor: Abbott (Ukraine)
• Information provided by (Responsible Party): AbbVie ( Abbott (Ukraine) )

Study Description

Brief Summary:

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 or disease
Anesthesia, General

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1365 participants
• 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)
• Study Start Date: April 2011
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Groups and Cohorts

Group/Cohort
Adults requiring anesthesia for surgery; Adult patients requiring general anesthesia for surgery

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 44445

Kyiv, Ukraine, 01133

Site Ref # / Investigator 49144

Kyiv, Ukraine, 02660

Site Ref # / Investigator 49145

Kyiv, Ukraine, 03680

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

• Responsible Party: Abbott (Ukraine)
• ClinicalTrials.gov Identifier: NCT01282086
• Other Study ID Numbers: P12-637
• First Posted: January 24, 2011
• Results First Posted: February 4, 2013
• Last Update Posted: February 4, 2013
• Last Verified: January 2013

Keywords provided by AbbVie ( Abbott (Ukraine) ):

Sevorane; Sevoflurane; General anesthesia; Inhalation anesthesia; General surgery