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

Condition(s) targeted: General Surgery

Intervention: sevoflurane (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Irina Magdik, MD, PhD, MBA, Study Director, Affiliation: Abbott Laboratories S.A., Ukraine

Overall contact:
Nadiia Sotnychenko, MD, Phone: +380444986080, Ext: 6017, Email: nadiia.sotnychenko@abbott.com

The main objective of this post-marketing observational study (PMOS) is to collect data of using general anesthesia in patients undergoing any surgery for creating local recommendations. These data will be based on the evaluation of volatile induction and maintenance anesthesia (VIMA) with Sevorane (sevoflurane) in adult patients required general anesthesia for surgery in terms of quality of anesthesia, its influence on cardiovascular system in common clinical practice in Ukraine

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

Study design: Time Perspective: Prospective

Primary outcome:

time of induction

time to awaking

time to extubation

doctors' satisfaction with using Sevorane for induction and maintenance anesthesia

patients' satisfaction and general impressions of using Sevorane anesthesia

Secondary outcome:

systolic arterial pressure

diastolic arterial pressure

mean arterial pressure

heart rate (beat per minute)

electrocardiogram data (if available)

cardiac troponin (Troponin T/I (ng/mL)) (if available)

creatine kinase myocardial isoenzyme (CFK-MB (units/L)) (if available)

length of clinical experience with modern inhalation agents

length of clinical experience of general anesthesia

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 anaesthesia 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Any patients needed 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

Nadiia Sotnychenko, MD, Phone: +380444986080, Ext: 6017, Email: nadiia.sotnychenko@abbott.com

Site Ref # / Investigator 49142, Kharkiv 61018, Ukraine; Recruiting
Site Ref # / Investigator 49142, Principal Investigator

Site Ref # / Investigator 52986, Kyiv 01014, Ukraine; Recruiting
Site Ref # / Investigator 52986, Principal Investigator

Site Ref # / Investigator 49144, Kyiv 02660, Ukraine; Recruiting
Site Ref # / Investigator 49144, Principal Investigator

Site Ref # / Investigator 49145, Kyiv 03680, Ukraine; Recruiting
Site Ref # / Investigator 49145, Principal Investigator

Site Ref # / Investigator 44445, Kyiv 01133, Ukraine; Recruiting
Site Ref # / Investigator 44445, Principal Investigator

Site Ref # / Investigator 49146, Lviv 79010, Ukraine; Recruiting
Site Ref # / Investigator 49146, Principal Investigator

Site Ref # / Investigator 49154, Mykolaiv 54058, Ukraine; Recruiting
Site Ref # / Investigator 49154, Principal Investigator

Site Ref # / Investigator 49148, Odesa 65025, Ukraine; Recruiting
Site Ref # / Investigator 49148, Principal Investigator

Site Ref # / Investigator 49152, Zaporizhia 69600, Ukraine; Recruiting
Site Ref # / Investigator 49152, Principal Investigator

Starting date: April 2011
Last updated: November 3, 2011