Evaluation of Volatile Induction and Maintenance Anesthesia (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
- Conditions
- Anesthesia, General
- Registration Number
- NCT01282203
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1122
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Awakening of Patients 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.
Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia Day 1 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).
Patients' Overall Impression of Anesthesia With Sevorane 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.
Time to Loss of Consciousness of Patients Administered Anesthesia Up to 10 minutes Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.
Time to Extubation of Patients 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.
- Secondary Outcome Measures
Name Time Method Cardiac Troponin (if Available) Within 24 hours after anesthesia Troponin T values measured within 24 hours of anesthesia were to be collected when available.
Creatine Kinase Myocardial Isoenzyme (if Available) Within 24 hours after anesthesia Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.
Mean Arterial Pressure Before starting anesthesia to one hour after the surgery 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.
Systolic Blood Pressure Before starting anesthesia to one hour after the surgery 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.
Diastolic Blood Pressure Before starting anesthesia to one hour after the surgery 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.
Presence of Deviations in Electrocardiogram Assessments During Anesthesia During induction and maintenance of 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).
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Before starting anesthesia to one hour after the surgery 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.
Heart Rate Before starting anesthesia to one hour after the surgery 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.
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command 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.
Anesthesiologists' Duration of Clinical Experience With Anesthesia Baseline 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.)
Trial Locations
- Locations (12)
Site Reference ID/Investigator# 64462
🇰🇿Kyzylorda, Kazakhstan
Site Reference ID/Investigator# 54704
🇰🇿Uralsk, 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# 54705
🇰🇿Astana, Kazakhstan
Site Reference ID/Investigator# 51844
🇰🇿Astana, Kazakhstan
Site Reference ID/Investigator# 51842
🇰🇿Kokshetau, Kazakhstan
Site Reference ID/Investigator# 51847
🇰🇿Kostanay, Kazakhstan
Site Reference ID/Investigator# 51845
🇰🇿Semey, Kazakhstan
Site Reference ID/Investigator# 51848
🇰🇿Shymkent, Kazakhstan
Site Reference ID/Investigator# 44446
🇰🇿Zhezkazgan, Kazakhstan