Clinical trial 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, General
Keywords: Sevorane
Sevoflurane
General anesthesia
Inhalation anesthesia
General surgery
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 1365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing planned or urgent surgery

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.

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 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

Primary outcomes:
measure: Time to Loss of Consciousness of Patients Administered Anesthesia
timeFrame: Up to 16 minutes
measure: Time to Awakening of Patients
timeFrame: Every minute after anesthesia was stopped until the patient responded to a verbal command
measure: Time to Extubation of Patients
timeFrame: Every minute after anesthesia was stopped until extubation occurred
measure: Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia
timeFrame: Day 1
measure: Patients' Overall Impression of the Anesthesia With Sevorane
timeFrame: Day 1
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: Before starting anesthesia to one hour after the operation
measure: Diastolic Blood Pressure
timeFrame: Before starting anesthesia to one hour after the operation
measure: Mean Arterial Pressure
timeFrame: Before starting anesthesia to one hour after the operation
measure: Heart Rate
timeFrame: Before starting anesthesia to one hour after the operation
measure: Presence of Deviations in Electrocardiogram Assessments During Anesthesia
timeFrame: During induction and maintenance of anesthesia on Day 1
measure: Cardiac Troponin (Troponin T) (if Available)
timeFrame: Within 24 hours after anesthesia
measure: Creatine Kinase Myocardial Isoenzyme (if Available)
timeFrame: Within 24 hours after anesthesia
measure: Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia
timeFrame: Before starting anesthesia to one hour after the operation
measure: Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening
timeFrame: Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.
Other outcomes:
Locations:
city: Dnipropetrovsk
country: Ukraine
facility: Site Ref # / Investigator 49151
city: Kharkiv
country: Ukraine
facility: Site Ref # / Investigator 49142
city: Kyiv
country: Ukraine
facility: Site Ref # / Investigator 52986
city: Kyiv
country: Ukraine
facility: Site Ref # / Investigator 44445
city: Kyiv
country: Ukraine
facility: Site Ref # / Investigator 49144
city: Kyiv
country: Ukraine
facility: Site Ref # / Investigator 49145
city: Lviv
country: Ukraine
facility: Site Ref # / Investigator 49146
city: Mykolaiv
country: Ukraine
facility: Site Ref # / Investigator 49154
city: Odesa
country: Ukraine
facility: Site Ref # / Investigator 49148
city: Zaporizhia
country: Ukraine
facility: Site Ref # / Investigator 49152
Study officials:
affiliation: Abbott Laboratories S.A., Ukraine
name: Irina Magdik, MD, PhD, MBA
role: STUDY_DIRECTOR
References: