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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 (SEVOPROTECTION)

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ClinicalTrials.gov Identifier: NCT01282203
Recruitment Status : Completed
First Posted : January 24, 2011
Results First Posted : January 7, 2013
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Time Perspective: Prospective
Condition Anesthesia, General
Enrollment 1122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adults Requiring Anesthesia for Surgery
Hide Arm/Group Description Adult patients requiring general anesthesia for surgery
Period Title: Overall Study
Started 1122
Completed 1121
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Adults Requiring Anesthesia for Surgery
Hide Arm/Group Description Adult patients requiring general anesthesia for surgery
Overall Number of Baseline Participants 1122
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1122 participants
45.1  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1122 participants
Female
619
  55.2%
Male
503
  44.8%
1.Primary Outcome
Title Time to Loss of Consciousness of Patients Administered Anesthesia
Hide Description Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.
Time Frame Up to 10 minutes
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Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 945
Mean (Standard Deviation)
Unit of Measure: Minutes
2.7  (1.4)
2.Primary Outcome
Title Time to Awakening of Patients
Hide Description Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.
Time Frame Every minute after anesthesia was stopped until the patient responded to a verbal command.
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Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 1116
Mean (Standard Deviation)
Unit of Measure: Minutes
15.4  (19.8)
3.Primary Outcome
Title Time to Extubation of Patients
Hide Description Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.
Time Frame Every minute after anesthesia was stopped until extubation occurred
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Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 1010
Mean (Standard Deviation)
Unit of Measure: Minutes
65.7  (127.5)
4.Primary Outcome
Title Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia
Hide Description 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).
Time Frame Day 1
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Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 1116
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.2  (1.1)
5.Primary Outcome
Title Patients' Overall Impression of Anesthesia With Sevorane
Hide Description 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 Frame Day 1
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Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 1114
Measure Type: Number
Unit of Measure: Participants
Excellent 476
Positive 627
Indifferent 11
Other 0
6.Secondary Outcome
Title Systolic Blood Pressure
Hide Description 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.
Time Frame Before starting anesthesia to one hour after the surgery
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Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 995
Mean (Standard Deviation)
Unit of Measure: mm Hg
Before anesthesia 137.5  (23.9)
Induction anesthesia (after intubation) 125.3  (22.3)
After surgical incision 117.6  (17.8)
After extubation 125.5  (14.1)
One hour after surgery 124.2  (12.5)
7.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description 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.
Time Frame Before starting anesthesia to one hour after the surgery
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Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 995
Mean (Standard Deviation)
Unit of Measure: mm Hg
Before anesthesia 84.7  (13.4)
Induction anesthesia (after intubation) 78.5  (30.2)
After surgical incision 73.2  (12.3)
After extubation 77.9  (11.7)
One hour after surgery 76.9  (10.5)
8.Secondary Outcome
Title Mean Arterial Pressure
Hide Description 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.
Time Frame Before starting anesthesia to one hour after the surgery
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Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 973
Mean (Standard Deviation)
Unit of Measure: mm Hg
Before anesthesia 103.9  (17.9)
Induction anesthesia (after intubation) 95.3  (18.0)
After surgical incision 89.5  (15.0)
After extubation 95.5  (13.0)
One hour after surgery 95.0  (12.1)
9.Secondary Outcome
Title Heart Rate
Hide Description 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.
Time Frame Before starting anesthesia to one hour after the surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with available data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 983
Mean (Standard Deviation)
Unit of Measure: beats per minute
Before anesthesia 83.4  (14.9)
Induction anesthesia (after intubation) 81.9  (15.0)
After surgical incision 79.1  (13.5)
After extubation 82.8  (10.4)
One hour after surgery 79.2  (9.0)
10.Secondary Outcome
Title Presence of Deviations in Electrocardiogram Assessments During Anesthesia
Hide Description 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).
Time Frame During induction and maintenance of anesthesia
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Hide Analysis Population Description
All participants with valid data were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 1057
Measure Type: Number
Unit of Measure: Participants
Blockades (induction) 9
Blockades (maintenance) 12
Extrasystoles (induction) 3
Extrasystoles (maintenance) 10
Arrhythmia (induction) 8
Arrhythmia (maintenance) 21
Myocardial ischemia (induction) 70
Myocardial ischemia (maintenance) 74
11.Secondary Outcome
Title Cardiac Troponin (if Available)
Hide Description Troponin T values measured within 24 hours of anesthesia were to be collected when available.
Time Frame Within 24 hours after anesthesia
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Hide Analysis Population Description
No data were available for the cardiac troponin outcome measure.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Creatine Kinase Myocardial Isoenzyme (if Available)
Hide Description Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.
Time Frame Within 24 hours after anesthesia
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Hide Analysis Population Description
No data were available for the creatine kinase myocardial isoenzyme outcome measure.
Arm/Group Title Adults Requiring Anesthesia for Surgery
Hide Arm/Group Description:
Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia
Hide Description 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.
Time Frame Before starting anesthesia to one hour after the surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with available data at each time point were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 1121
Measure Type: Number
Unit of Measure: Spearman's correlation coefficient
Systolic blood pressure (T1- T0; n=1121) 0.271
Systolic blood pressure (T2-T0; n=1121) 0.207
Systolic blood pressure (T3 -T0; n=1005) 0.143
Systolic blood pressure (T4 -T0; n=1105) 0.131
Systolic blood pressure (Minimum -T0; n=1120) 0.213
Systolic blood pressure (Maximum -T0; n=1120) 0.153
Diastolic blood pressure (T1-T0; n=1119) 0.289
Diastolic blood pressure (T2-T0; n=1119) 0.243
Diastolic blood pressure (T3-T0; n=1005) 0.203
Diastolic blood pressure (T4-T0; n=1105) 0.196
Diastolic blood pressure (Minimum-T0; n=1118) 0.288
Diastolic blood pressure (Maximum-T0; n=1118) 0.163
Mean arterial blood pressure (T1-T0; n=1101) 0.308
Mean arterial blood pressure (T2-T0; n=1102) 0.250
Mean arterial blood pressure (T3-T0; n=988) 0.199
Mean arterial blood pressure (T4-T0; n=1084) 0.196
Mean arterial blood pressure (Minimum-T0; n=1099) 0.288
Mean arterial blood pressure (Maximum-T0; n=1099) 0.177
Heart rate (T1-T0; n=1117) 0.269
Heart rate (T2-T0; n=1116) 0.245
Heart rate (T3-T0; n=995) -0.040
Heart rate (T4-T0; n=1101) -0.030
Heart rate (Minimum-T0; n=1115) 0.223
Heart rate (Maximum-T0; n=1116) 0.120
14.Secondary Outcome
Title Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening
Hide Description 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.
Time Frame Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with available data at each time point were included in the analysis.
Arm/Group Title Adults Requiring Anesthesia for Surgery
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Adult patients requiring general anesthesia for surgery
Overall Number of Participants Analyzed 1116
Measure Type: Number
Unit of Measure: Spearman's correlation coefficient
Exp w/ inh anesthesia (time to extubation; n=1010) -0.720
Exp w/ inh anesthesia (time to awakening; n=1116) -0.415
Exp w/ Sevorane (time to extubation; n=1010) -0.681
Exp w/ Sevorane (time to awakening; n=1116) -0.294
15.Secondary Outcome
Title Anesthesiologists' Duration of Clinical Experience With Anesthesia
Hide Description 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.)
Time Frame Baseline
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Number of anesthesiologists participating in study.
Arm/Group Title General Anesthesia Inhalation Anesthesia Anesthesia With Sevorane
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Duration of experience with general anesthesia.
Duration of experience with inhalation anesthesia.
Duration of experience with Sevorane.
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Deviation)
Unit of Measure: years
17.8  (9.2) 15.4  (11.6) 3.5  (2.5)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adults Requiring Anesthesia for Surgery
Hide Arm/Group Description Adult patients requiring general anesthesia for surgery
All-Cause Mortality
Adults Requiring Anesthesia for Surgery
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adults Requiring Anesthesia for Surgery
Affected / at Risk (%)
Total   4/1122 (0.36%) 
Cardiac disorders   
Ventricular fibrillation  1  2/1122 (0.18%) 
Cardiac failure acute  1  1/1122 (0.09%) 
Myocardial infarction  1  1/1122 (0.09%) 
Atrial fibrillation  1  1/1122 (0.09%) 
Cardiac arrest  1  1/1122 (0.09%) 
Injury, poisoning and procedural complications   
Post-procedural hemorrhage  1  1/1122 (0.09%) 
Investigations   
Hypokalemia  1  1/1122 (0.09%) 
Vascular disorders   
Hypertension  1  1/1122 (0.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adults Requiring Anesthesia for Surgery
Affected / at Risk (%)
Total   1/1122 (0.09%) 
Vascular disorders   
Blood pressure increased  1  1/1122 (0.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor Abbott)
Phone: 1-800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01282203     History of Changes
Other Study ID Numbers: P12-638
First Submitted: January 21, 2011
First Posted: January 24, 2011
Results First Submitted: November 30, 2012
Results First Posted: January 7, 2013
Last Update Posted: March 4, 2013