Anesthesia, GeneralSEVOPROTECTIONNCT01282086

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

An observational study of Anesthesia, General, run by Abbott (Ukraine) at 10 sites in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anesthesia, General
How many people: 1,365 participants
Where: 10 sitesUkraine
Study dates: Apr 2011to Dec 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing planned or urgent surgery

Who may be able to join

Patients needing general anesthesia for planned or urgent surgery for whom Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Ukraine10 sites

Site Ref # / Investigator 49151
Dnipropetrovsk, 49005
Site Ref # / Investigator 49142
Kharkiv, 61018
Site Ref # / Investigator 52986
Kyiv, 01014
Site Ref # / Investigator 44445
Kyiv, 01133
Site Ref # / Investigator 49144
Kyiv, 02660
Site Ref # / Investigator 49145
Kyiv, 03680
Site Ref # / Investigator 49146
Lviv, 79010
Site Ref # / Investigator 49154
Mykolaiv, 54058
Site Ref # / Investigator 49148
Odesa, 65025
Site Ref # / Investigator 49152
Zaporizhia, 69600

Other trials in Ukraine

About this study

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)

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.

Read the 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 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: Anesthesia, General
Keywords: Sevorane, Sevoflurane, General anesthesia, Inhalation anesthesia, General surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01282086
Study group	Role	What they receive
Adults requiring anesthesia for surgery		Adult patients requiring general anesthesia for surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 16 minutes
Time to Awakening of Patients
Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.
Measured: Every minute after anesthesia was stopped until the patient responded to a verbal command
Time to Extubation of Patients
Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.
Measured: Every minute after anesthesia was stopped until extubation occurred
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).
Measured: Day 1
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.
Measured: Day 1

Secondary outcomes (9)

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.
Measured: Before starting anesthesia to one hour after the operation
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.
Measured: Before starting anesthesia to one hour after the operation
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.
Measured: Before starting anesthesia to one hour after the operation
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.
Measured: Before starting anesthesia to one hour after the operation
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).
Measured: During induction and maintenance of anesthesia on Day 1
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.
Measured: Within 24 hours after anesthesia
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.
Measured: Within 24 hours after anesthesia
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.
Measured: Before starting anesthesia to one hour after the operation
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.
Measured: Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Dec 2011

First posted24 Jan 2011 (estimated)
Study startApr 2011
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 1,365 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01282086
Sponsor's protocol ID: P12-637
Acronym: SEVOPROTECTION
Status last verified: Jan 2013
First submitted: 21 Jan 2011
Last updated: 4 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anesthesia, General trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01282086
Acronym / sponsor ID: SEVOPROTECTION / P12-637
Conditions: Anesthesia, General
Keywords: Sevorane, Sevoflurane, General anesthesia, Inhalation anesthesia, General surgery
Study type: Observational
Recruitment status: Completed
Enrolment: 1,365 participants (actual)
Lead sponsor: Abbott (Ukraine)Industry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 24 Jan 2011 (estimated)
Results: Posted 4 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Adults requiring anesthesia for surgery	–	–Adult patients requiring general anesthesia for surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing planned or urgent surgery

Key inclusion criteria (1 listed)

Patients needing general anesthesia for planned or urgent surgery for whom Sevorane is used for induction and maintenance anesthesia by the choice of anesthesiologist

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Time to Loss of Consciousness of Patients Administered Anesthesia
Time frame: Up to 16 minutes
Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.
Time to Awakening of Patients
Time frame: Every minute after anesthesia was stopped until the patient responded to a verbal command
Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.
Time to Extubation of Patients
Time frame: Every minute after anesthesia was stopped until extubation occurred
Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.
Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia
Time frame: Day 1
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).
Patients' Overall Impression of the Anesthesia With Sevorane
Time frame: Day 1
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.

9 secondary outcomes

Systolic Blood Pressure
Time frame: Before starting anesthesia to one hour after the operation
Diastolic Blood Pressure
Time frame: Before starting anesthesia to one hour after the operation
Mean Arterial Pressure
Time frame: Before starting anesthesia to one hour after the operation
Heart Rate
Time frame: Before starting anesthesia to one hour after the operation
Presence of Deviations in Electrocardiogram Assessments During Anesthesia
Time frame: During induction and maintenance of anesthesia on Day 1
Cardiac Troponin (Troponin T) (if Available)
Time frame: Within 24 hours after anesthesia
Creatine Kinase Myocardial Isoenzyme (if Available)
Time frame: Within 24 hours after anesthesia
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia
Time frame: Before starting anesthesia to one hour after the operation
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening
Time frame: Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.

Results and safety

Results posted to the registry on 4 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adults Requiring Anesthesia for Surgery	1,365	1,365

Primary outcome: Time to Loss of Consciousness of Patients Administered Anesthesia

Time frame: Up to 16 minutes. Mean (Standard Deviation). Unit: minutes

Measure	Adults Requiring Anesthesia for Surgery n = 1343
Value	3.0 (1.8)

Population analysed: All participants with available data were included in the analysis.

Primary outcome: Time to Awakening of Patients

Time frame: Every minute after anesthesia was stopped until the patient responded to a verbal command. Mean (Standard Deviation). Unit: minutes

Measure	Adults Requiring Anesthesia for Surgery n = 1359
Value	16.3 (38.7)

Population analysed: All participants with available data were included in the analysis.

Primary outcome: Time to Extubation of Patients

Time frame: Every minute after anesthesia was stopped until extubation occurred. Mean (Standard Deviation). Unit: minutes

Measure	Adults Requiring Anesthesia for Surgery n = 1359
Value	99.2 (481.8)

Population analysed: All participants with available data were included in the analysis.

Primary outcome: Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia

Time frame: Day 1. Mean (Standard Deviation). Unit: units on a scale

Measure	Adults Requiring Anesthesia for Surgery n = 1365
Value	8.6 (1.4)

Population analysed: All participants with available data were included in the analysis.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adults Requiring Anesthesia for Surgery	2 of 1,365 (0.1%)	7 of 1,365 (0.5%)	Not reported

Limitations and caveats (from the sponsor): The data on troponin T values were not collected in the study and CK-MB was detected in a small number of patients, therefore no conclusions can be made regarding the influence of VIMA with Sevorane on myocardial ischemia markers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Irina Magdik, MD, PhD, MBA study director

Abbott Laboratories S.A., Ukraine

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, General, run by Abbott (Ukraine) at 10 sites in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Loss of Consciousness of Patients Administered Anesthesia (time frame: Up to 16 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01282086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.