Clinical trial NCT01282203: Evaluation of Volatile Induction and Maintenance Anesthesia (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
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: General surgery
General anesthesia
Inhalation anesthesia
Sevorane
Sevoflurane
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 1122
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 is to collect data from the use of 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 cardiovascular system in common clinical practice in Kazakhstan.

Detailed description: This post-marketing observational study 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 start of anesthesia through 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 Sevorane 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
* Age greater than or equal to 18 years

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 10 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 Anesthesia With Sevorane
timeFrame: Day 1
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: Before starting anesthesia to one hour after the surgery
measure: Diastolic Blood Pressure
timeFrame: Before starting anesthesia to one hour after the surgery
measure: Mean Arterial Pressure
timeFrame: Before starting anesthesia to one hour after the surgery
measure: Heart Rate
timeFrame: Before starting anesthesia to one hour after the surgery
measure: Presence of Deviations in Electrocardiogram Assessments During Anesthesia
timeFrame: During induction and maintenance of anesthesia
measure: Cardiac Troponin (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 surgery
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
measure: Anesthesiologists' Duration of Clinical Experience With Anesthesia
timeFrame: Baseline
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Site Reference ID/Investigator# 51851
city: Almaty
country: Kazakhstan
facility: Site Reference ID/Investigator# 54703
city: Astana
country: Kazakhstan
facility: Site Reference ID/Investigator# 51843
city: Astana
country: Kazakhstan
facility: Site Reference ID/Investigator# 51844
city: Astana
country: Kazakhstan
facility: Site Reference ID/Investigator# 54705
city: Kokshetau
country: Kazakhstan
facility: Site Reference ID/Investigator# 51842
city: Kostanay
country: Kazakhstan
facility: Site Reference ID/Investigator# 51847
city: Kyzylorda
country: Kazakhstan
facility: Site Reference ID/Investigator# 64462
city: Semey
country: Kazakhstan
facility: Site Reference ID/Investigator# 51845
city: Shymkent
country: Kazakhstan
facility: Site Reference ID/Investigator# 51848
city: Uralsk
country: Kazakhstan
facility: Site Reference ID/Investigator# 54704
city: Zhezkazgan
country: Kazakhstan
facility: Site Reference ID/Investigator# 44446
Study officials:
affiliation: Abbott Laboratories S.A., Ukraine
name: Galyna Bryn, PhD
role: STUDY_DIRECTOR
References: