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

NCT ID: NCT01282203

Last Updated: 2013-03-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-11-30

Brief Summary

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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

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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.

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

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.

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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Galyna Bryn, PhD

Role: STUDY_DIRECTOR

Abbott Laboratories S.A., Ukraine

Locations

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Site Reference ID/Investigator# 51851

Almaty, , Kazakhstan

Site Status

Site Reference ID/Investigator# 54703

Almaty, , Kazakhstan

Site Status

Site Reference ID/Investigator# 51843

Astana, , Kazakhstan

Site Status

Site Reference ID/Investigator# 51844

Astana, , Kazakhstan

Site Status

Site Reference ID/Investigator# 54705

Astana, , Kazakhstan

Site Status

Site Reference ID/Investigator# 51842

Kokshetau, , Kazakhstan

Site Status

Site Reference ID/Investigator# 51847

Kostanay, , Kazakhstan

Site Status

Site Reference ID/Investigator# 64462

Kyzylorda, , Kazakhstan

Site Status

Site Reference ID/Investigator# 54704

Oral, , Kazakhstan

Site Status

Site Reference ID/Investigator# 51845

Semey, , Kazakhstan

Site Status

Site Reference ID/Investigator# 51848

Shymkent, , Kazakhstan

Site Status

Site Reference ID/Investigator# 44446

Zhezqazghan, , Kazakhstan

Site Status

Countries

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Kazakhstan

Related Links

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Other Identifiers

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P12-638

Identifier Type: -

Identifier Source: org_study_id

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