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

Anesthesia, General Clinical Trial

— SEVOPROTECTION  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282086
• Other study ID #: P12-637
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: January 4, 2013
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ukraine: Ministry of HealthUkraine: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1365
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia, General

Locations

Country	Name	City	State
Ukraine	Site Ref # / Investigator 49151	Dnipropetrovsk
Ukraine	Site Ref # / Investigator 49142	Kharkiv
Ukraine	Site Ref # / Investigator 44445	Kyiv
Ukraine	Site Ref # / Investigator 49144	Kyiv
Ukraine	Site Ref # / Investigator 49145	Kyiv
Ukraine	Site Ref # / Investigator 52986	Kyiv
Ukraine	Site Ref # / Investigator 49146	Lviv
Ukraine	Site Ref # / Investigator 49154	Mykolaiv
Ukraine	Site Ref # / Investigator 49148	Odesa
Ukraine	Site Ref # / Investigator 49152	Zaporizhia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott (Ukraine)

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Loss of Consciousness of Patients Administered Anesthesia	Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.	Up to 16 minutes	No
Primary	Time to Awakening of Patients	Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.	Every minute after anesthesia was stopped until the patient responded to a verbal command	No
Primary	Time to Extubation of Patients	Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.	Every minute after anesthesia was stopped until extubation occurred	No
Primary	Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia	The anesthesiologist's overall satisfaction with the inhalation anesthesia with Sevorane for each patient was assessed by means of a numerical rating scale ranging from 0 (dissatisfied) to 10 (very satisfied).	Day 1	No
Primary	Patients' Overall Impression of the Anesthesia With Sevorane	After awakening from anesthesia, patients were surveyed regarding their overall impression of anesthesia with Sevorane. Patients selected one of the following answers: excellent, positive, indifferent, or other.	Day 1	No
Secondary	Systolic Blood Pressure	The systolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.	Before starting anesthesia to one hour after the operation	No
Secondary	Diastolic Blood Pressure	The diastolic blood pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.	Before starting anesthesia to one hour after the operation	No
Secondary	Mean Arterial Pressure	The mean arterial pressure of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.	Before starting anesthesia to one hour after the operation	No
Secondary	Heart Rate	The heart rate of each patient was recorded at different time points from just before the start of anesthesia to one hour after the operation concluded.	Before starting anesthesia to one hour after the operation	No
Secondary	Presence of Deviations in Electrocardiogram Assessments During Anesthesia	Electrocardiogram (ECG) assessments performed during induction of the anesthesia and maintenance were analyzed with respect to the presence of the following deviations: blockades (problems with heart electrical activity), extrasystoles (extra abnormal heart beats), arrhythmia (abnormal heart rate or rhythm), and myocardial ischemia (decreased blood flow to the heart).	During induction and maintenance of anesthesia on Day 1	No
Secondary	Cardiac Troponin (Troponin T) (if Available)	Troponin T values measured within 24 hours of anesthesia were to be collected when available. No data were reported for this outcome measure during the study.	Within 24 hours after anesthesia	No
Secondary	Creatine Kinase Myocardial Isoenzyme (if Available)	Creatine kinase myocardial isoenzyme (CK-MB) values measured within 24 hours of anesthesia were to be collected when available.	Within 24 hours after anesthesia	No
Secondary	Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia	The anesthesiologists' length of clinical experience with Sevorane was collected. The influence of this experience on the changes in hemodynamic parameters during anesthesia with Sevorane was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with Sevorane and the changes in blood pressure, mean arterial pressure, and heart rate between T0 (before anesthesia) and T1 (at the end of induction), T2 (at the end of surgical incision), T3 (at the end of extubation), T4 (1 hour after the operation), and the minimum and maximum values, respectively.	Before starting anesthesia to one hour after the operation	No
Secondary	Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening	Anesthesiologists' length of clinical experience with general anesthesia and modern inhalation agents was collected. The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience (exp) with inhalation (inh) anesthesia and Sevorane on the time to extubation and the time to awakening, respectively.	Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.	No