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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults requiring anesthesia for surgery | Adult patients requiring general anesthesia for surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Diastolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing planned or urgent surgery
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| Name | Affiliation | Role |
|---|---|---|
| Irina Magdik, MD, PhD, MBA | Abbott Laboratories S.A., Ukraine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 49151 | Dnipropetrovsk | 49005 | Ukraine | |||
| Site Ref # / Investigator 49142 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults Requiring Anesthesia for Surgery | Adult patients requiring general anesthesia for surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| Kharkiv |
| 61018 |
| Ukraine |
| Site Ref # / Investigator 52986 | Kyiv | 01014 | Ukraine |
| Site Ref # / Investigator 44445 | Kyiv | 01133 | Ukraine |
| Site Ref # / Investigator 49144 | Kyiv | 02660 | Ukraine |
| Site Ref # / Investigator 49145 | Kyiv | 03680 | Ukraine |
| Site Ref # / Investigator 49146 | Lviv | 79010 | Ukraine |
| Site Ref # / Investigator 49154 | Mykolaiv | 54058 | Ukraine |
| Site Ref # / Investigator 49148 | Odesa | 65025 | Ukraine |
| Site Ref # / Investigator 49152 | Zaporizhia | 69600 | Ukraine |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults Requiring Anesthesia for Surgery | Adult patients requiring general anesthesia for surgery |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Up to 16 minutes |
|
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| Primary | Time to Awakening of Patients | Measured from the time anesthesia administration was stopped until the patient responded to a verbal command. | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Every minute after anesthesia was stopped until the patient responded to a verbal command |
|
| ||||||||||||||||||||||||||
| Primary | Time to Extubation of Patients | Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred. | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | minutes | Every minute after anesthesia was stopped until extubation occurred |
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| 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). | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
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| 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. | All participants with available data were included in the analysis. | Posted | Number | participants | Day 1 |
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| 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. | All participants with available data were included in the analysis. n= the number of participants with available data at given time point. | Posted | Mean | Standard Deviation | mm Hg | Before starting anesthesia to one hour after the operation |
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| 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. | All participants with available data were included in the analysis. n=the number of participants with available data at given time point. | Posted | Mean | Standard Deviation | mm Hg | Before starting anesthesia to one hour after the operation |
|
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| 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. | All participants with available data were included in the analysis. n=the number of participants with available data at given time point. | Posted | Mean | Standard Deviation | mm Hg | Before starting anesthesia to one hour after the operation |
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| 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. | All participants with available data were included in the analysis. n=the number of participants with available data at given time point. | Posted | Mean | Standard Deviation | beats per minute | Before starting anesthesia to one hour after the operation |
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| 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). | All participants with valid data were included in the analysis. | Posted | Number | participants | During induction and maintenance of anesthesia on Day 1 |
|
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| 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. | No data were available for the cardiac troponin outcome measure. | Posted | Within 24 hours after anesthesia |
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| 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. | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | U/L | Within 24 hours after anesthesia |
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| 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. | All participants with available data were included in the analysis. n=the number of participants with available data at given time point. | Posted | Number | Spearman's correlation coefficient | Before starting anesthesia to one hour after the operation |
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| 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. | All participants with available data at each time point were included in the analysis. | Posted | Number | Spearman's correlation coefficient | Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command. |
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Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults Requiring Anesthesia for Surgery | Adult patients requiring general anesthesia for surgery | 2 | 1,365 | 7 | 1,365 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| Operative Hemorrhage | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unwanted Awareness During Anesthesia | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 14.0 | Systematic Assessment |
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| Cognitive Disorders | Nervous system disorders | 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 14.0 | Systematic Assessment |
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| Hyperthermia | General disorders | 14.0 | Systematic Assessment |
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| Psychomotor Hyperactivity | Psychiatric disorders | 14.0 | Systematic Assessment |
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| Laryngospasm | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | 14.0 | Systematic Assessment |
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| Endotracheal Intubation Complication | Injury, poisoning and procedural complications | 14.0 | Systematic Assessment |
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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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott (Ukraine) | 1-800-633-9110 |
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