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

NCT ID: NCT01282086

Last Updated: 2013-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Anesthesia, General

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Adults requiring anesthesia for surgery

Adult patients requiring general anesthesia for surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott (Ukraine)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irina Magdik, MD, PhD, MBA

Role: STUDY_DIRECTOR

Abbott Laboratories S.A., Ukraine

Locations

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Site Ref # / Investigator 49151

Dnipropetrovsk, , Ukraine

Site Status

Site Ref # / Investigator 49142

Kharkiv, , Ukraine

Site Status

Site Ref # / Investigator 52986

Kyiv, , Ukraine

Site Status

Site Ref # / Investigator 44445

Kyiv, , Ukraine

Site Status

Site Ref # / Investigator 49144

Kyiv, , Ukraine

Site Status

Site Ref # / Investigator 49145

Kyiv, , Ukraine

Site Status

Site Ref # / Investigator 49146

Lviv, , Ukraine

Site Status

Site Ref # / Investigator 49154

Mykolaiv, , Ukraine

Site Status

Site Ref # / Investigator 49148

Odesa, , Ukraine

Site Status

Site Ref # / Investigator 49152

Zaporizhia, , Ukraine

Site Status

Countries

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Ukraine

Other Identifiers

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P12-637

Identifier Type: -

Identifier Source: org_study_id

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