Anesthesia, General Clinical Trial
— SEVOPROTECTIONOfficial 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 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.
Status | Completed |
Enrollment | 1122 |
Est. completion date | November 2011 |
Est. primary completion date | November 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 - Age greater than or equal to 18 years 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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Kazakhstan | Site Reference ID/Investigator# 51851 | Almaty | |
Kazakhstan | Site Reference ID/Investigator# 54703 | Almaty | |
Kazakhstan | Site Reference ID/Investigator# 51843 | Astana | |
Kazakhstan | Site Reference ID/Investigator# 51844 | Astana | |
Kazakhstan | Site Reference ID/Investigator# 54705 | Astana | |
Kazakhstan | Site Reference ID/Investigator# 51842 | Kokshetau | |
Kazakhstan | Site Reference ID/Investigator# 51847 | Kostanay | |
Kazakhstan | Site Reference ID/Investigator# 64462 | Kyzylorda | |
Kazakhstan | Site Reference ID/Investigator# 51845 | Semey | |
Kazakhstan | Site Reference ID/Investigator# 51848 | Shymkent | |
Kazakhstan | Site Reference ID/Investigator# 54704 | Uralsk | |
Kazakhstan | Site Reference ID/Investigator# 44446 | Zhezkazgan |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
Kazakhstan,
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 10 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 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 | No |
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. | 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 surgery concluded. | Before starting anesthesia to one hour after the surgery | 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 surgery concluded. | Before starting anesthesia to one hour after the surgery | 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 surgery concluded. | Before starting anesthesia to one hour after the surgery | 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 surgery concluded. | Before starting anesthesia to one hour after the surgery | 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 | No |
Secondary | Cardiac Troponin (if Available) | Troponin T values measured within 24 hours of anesthesia were to be collected when available. | Within 24 hours after anesthesia | No |
Secondary | 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 | No |
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. | Before starting anesthesia to one hour after the surgery | 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 (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 | No |
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.) | Baseline | No |
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