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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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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 10 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 overall satisfaction of the anesthesiologist 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 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 surgery concluded. | Before starting anesthesia to one hour after the surgery |
| 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 |
|---|---|---|
| Galyna Bryn, PhD | Abbott Laboratories S.A., Ukraine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 51851 | Almaty | 050000 | Kazakhstan | |||
| Site Reference ID/Investigator# 54703 |
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| Label | URL |
|---|---|
| Related Info | View source |
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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 surgery concluded. |
| Before starting anesthesia to one hour after the surgery |
| 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 surgery concluded. | Before starting anesthesia to one hour after the surgery |
| 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 surgery concluded. | Before starting anesthesia to one hour after the surgery |
| 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 |
| Cardiac Troponin (if Available) | Troponin T values measured within 24 hours of anesthesia were to be collected when available. | Within 24 hours after anesthesia |
| Creatine Kinase Myocardial Isoenzyme (if Available) | Creatine kinase myocardial isoenzyme 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 (see Outcome Measure 15). 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 surgery), and the minimum and maximum values, respectively. | Before starting anesthesia to one hour after the surgery |
| 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 (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation 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 |
| Anesthesiologists' Duration of Clinical Experience With Anesthesia | Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.) | Baseline |
| Almaty |
| 050012 |
| Kazakhstan |
| Site Reference ID/Investigator# 51843 | Astana | 010000 | Kazakhstan |
| Site Reference ID/Investigator# 51844 | Astana | 010000 | Kazakhstan |
| Site Reference ID/Investigator# 54705 | Astana | 010000 | Kazakhstan |
| Site Reference ID/Investigator# 51842 | Kokshetau | 020000 | Kazakhstan |
| Site Reference ID/Investigator# 51847 | Kostanay | 110000 | Kazakhstan |
| Site Reference ID/Investigator# 64462 | Kyzylorda | 120008 | Kazakhstan |
| Site Reference ID/Investigator# 54704 | Oral | 090000 | Kazakhstan |
| Site Reference ID/Investigator# 51845 | Semey | 071403 | Kazakhstan |
| Site Reference ID/Investigator# 51848 | Shymkent | 160000 | Kazakhstan |
| Site Reference ID/Investigator# 44446 | Zhezqazghan | 100600 | Kazakhstan |
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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 10 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. |
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| 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 overall satisfaction of the anesthesiologist 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 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 surgery concluded. | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | mm Hg | Before starting anesthesia to one hour after the surgery |
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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 surgery concluded. | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | mm Hg | Before starting anesthesia to one hour after the surgery |
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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 surgery concluded. | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | mm Hg | Before starting anesthesia to one hour after the surgery |
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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 surgery concluded. | All participants with available data were included in the analysis. | Posted | Mean | Standard Deviation | beats per minute | Before starting anesthesia to one hour after the surgery |
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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 |
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| Secondary | Cardiac Troponin (if Available) | Troponin T values measured within 24 hours of anesthesia were to be collected when available. | 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 values measured within 24 hours of anesthesia were to be collected when available. | No data were available for the creatine kinase myocardial isoenzyme outcome measure. | Posted | 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 (see Outcome Measure 15). 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 surgery), and the minimum and maximum values, respectively. | All participants with available data at each time point were included in the analysis. | Posted | Number | Spearman's correlation coefficient | Before starting anesthesia to one hour after the surgery |
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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 (see Outcome Measure 15). The influence of this clinical experience on anesthesia parameters was evaluated by calculating Spearman's correlation coefficient between the duration of clinical experience with inhalation 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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| Secondary | Anesthesiologists' Duration of Clinical Experience With Anesthesia | Mean number of years of participating anesthesiologists' clinical experience with general anesthesia, with modern inhalation agents, and with Sevorane. (See Outcome Measures 13 and 14 for correlated data.) | Number of anesthesiologists participating in study. | Posted | Mean | Standard Deviation | years | Baseline |
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Physicians reported all serious adverse events occurring during the induction, maintenance, and recovery phases of surgery until 30 days or 5 half-lives following termination of Sevorane. Mean (SD) total duration of anesthesia was 98.4 (67.2) minutes.
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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 | 4 | 1,122 | 1 | 1,122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Post-procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Hypokalemia | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure increased | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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Troponin T and CK-MB values were not collected in the study, therefore no conclusions can be made regarding the influence of volatile induction and maintenance anesthesia 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 | AbbVie (prior sponsor Abbott) | 1-800-633-9110 |
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| Title | Denominators | Categories | ||||
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| Excellent |
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| Positive |
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| Indifferent |
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| Other |
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| Title | Denominators | Categories | ||||
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| Before anesthesia |
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| Induction anesthesia (after intubation) |
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| After surgical incision |
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| After extubation |
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| One hour after surgery |
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| Title | Denominators | Categories | ||||
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| Before anesthesia |
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| Induction anesthesia (after intubation) |
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| After surgical incision |
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| After extubation |
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| One hour after surgery |
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| Title | Denominators | Categories | ||||
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| Before anesthesia |
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| Induction anesthesia (after intubation) |
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| After surgical incision |
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| After extubation |
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| One hour after surgery |
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| Title | Denominators | Categories | ||||
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| Before anesthesia |
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| Induction anesthesia (after intubation) |
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| After surgical incision |
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| After extubation |
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| One hour after surgery |
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