Trial Outcomes & Findings for Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane 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 (NCT NCT01282086)

NCT ID: NCT01282086

Last Updated: 2013-02-04

Results Overview

Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.

• Recruitment status: COMPLETED
• Target enrollment: 1365 participants
• Primary outcome timeframe: Up to 16 minutes
• Results posted on: 2013-02-04

Participant Flow

Participant milestones

Measure	Adults Requiring Anesthesia for Surgery Adult patients requiring general anesthesia for surgery
Overall Study STARTED	1365
Overall Study COMPLETED	1365
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane 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

Baseline characteristics by cohort

Measure	Adults Requiring Anesthesia for Surgery n=1365 Participants Adult patients requiring general anesthesia for surgery
Age Continuous	44.6 years STANDARD_DEVIATION 3.0 • n=5 Participants
Sex: Female, Male Female	894 Participants n=5 Participants
Sex: Female, Male Male	471 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 16 minutes

Population: All participants with available data were included in the analysis.

Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (loss of eyelash reflex) occurred.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1343 Participants Adult patients requiring general anesthesia for surgery
Time to Loss of Consciousness of Patients Administered Anesthesia	3.0 minutes Standard Deviation 1.8

PRIMARY outcome

Timeframe: Every minute after anesthesia was stopped until the patient responded to a verbal command

Population: All participants with available data were included in the analysis.

Measured from the time anesthesia administration was stopped until the patient responded to a verbal command.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1359 Participants Adult patients requiring general anesthesia for surgery
Time to Awakening of Patients	16.3 minutes Standard Deviation 38.7

PRIMARY outcome

Timeframe: Every minute after anesthesia was stopped until extubation occurred

Population: All participants with available data were included in the analysis.

Time to extubation was measured from the time anesthesia administration was stopped until tracheal extubation occurred.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1359 Participants Adult patients requiring general anesthesia for surgery
Time to Extubation of Patients	99.2 minutes Standard Deviation 481.8

PRIMARY outcome

Timeframe: Day 1

Population: All participants with available data were included in the analysis.

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).

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1365 Participants Adult patients requiring general anesthesia for surgery
Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia	8.6 units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: Day 1

Population: All participants with available data were included in the analysis.

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1354 Participants Adult patients requiring general anesthesia for surgery
Patients' Overall Impression of the Anesthesia With Sevorane Excellent	527 participants
Patients' Overall Impression of the Anesthesia With Sevorane Positive	767 participants
Patients' Overall Impression of the Anesthesia With Sevorane Indifferent	56 participants
Patients' Overall Impression of the Anesthesia With Sevorane Other	4 participants

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the operation

Population: All participants with available data were included in the analysis. n= the number of participants with available data at given time point.

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1363 Participants Adult patients requiring general anesthesia for surgery
Systolic Blood Pressure Before anesthesia (n=1363)	135.4 mm Hg Standard Deviation 17.9
Systolic Blood Pressure Induction anesthesia (after intubation) (n=1362)	116.6 mm Hg Standard Deviation 19.0
Systolic Blood Pressure After surgical incision (n=1362)	115.0 mm Hg Standard Deviation 16.7
Systolic Blood Pressure After extubation (n=1360)	123.8 mm Hg Standard Deviation 15.8
Systolic Blood Pressure One hour after operation (n=1339)	122.3 mm Hg Standard Deviation 14.5

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the operation

Population: All participants with available data were included in the analysis. n=the number of participants with available data at given time point.

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1364 Participants Adult patients requiring general anesthesia for surgery
Diastolic Blood Pressure Before anesthesia (n=1364)	83.1 mm Hg Standard Deviation 12.2
Diastolic Blood Pressure Induction anesthesia (after intubation) (n=1363)	72.8 mm Hg Standard Deviation 13.5
Diastolic Blood Pressure After surgical incision (n=1363)	71.6 mm Hg Standard Deviation 12.7
Diastolic Blood Pressure After extubation (n=1361)	76.0 mm Hg Standard Deviation 12.2
Diastolic Blood Pressure One hour after operation (n=1340)	75.1 mm Hg Standard Deviation 11.2

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the operation

Population: All participants with available data were included in the analysis. n=the number of participants with available data at given time point.

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1341 Participants Adult patients requiring general anesthesia for surgery
Mean Arterial Pressure One hour after operation (n=1316)	91.7 mm Hg Standard Deviation 13.3
Mean Arterial Pressure Before anesthesia (n=1341)	101.9 mm Hg Standard Deviation 16.4
Mean Arterial Pressure Induction anesthesia (after intubation) (n=1340)	88.2 mm Hg Standard Deviation 16.4
Mean Arterial Pressure After surgical incision (n=1340)	86.8 mm Hg Standard Deviation 14.2
Mean Arterial Pressure After extubation (n=1336)	94.1 mm Hg Standard Deviation 33.5

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the operation

Population: All participants with available data were included in the analysis. n=the number of participants with available data at given time point.

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1363 Participants Adult patients requiring general anesthesia for surgery
Heart Rate Before anesthesia (n=1363)	83.2 beats per minute Standard Deviation 14.6
Heart Rate Induction anesthesia (after intubation) (n=1363)	79.8 beats per minute Standard Deviation 15.4
Heart Rate After surgical incision (n=1363)	77.4 beats per minute Standard Deviation 13.9
Heart Rate After extubation (n=1353)	81.2 beats per minute Standard Deviation 13.2
Heart Rate One hour after operation (n=1336)	77.5 beats per minute Standard Deviation 11.1

SECONDARY outcome

Timeframe: During induction and maintenance of anesthesia on Day 1

Population: All participants with valid data were included in the analysis.

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).

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1347 Participants Adult patients requiring general anesthesia for surgery
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Extrasystoles (maintenance)	20 participants
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Blockades (induction)	1 participants
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Blockades (maintenance)	6 participants
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Extrasystoles (induction)	3 participants
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Arrhythmia (induction)	5 participants
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Arrhythmia (maintenance)	15 participants
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Myocardial ischemia (induction)	0 participants
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Myocardial ischemia (maintenance)	8 participants

SECONDARY outcome

Timeframe: Within 24 hours after anesthesia

Population: No data were available for the cardiac troponin outcome measure.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 24 hours after anesthesia

Population: All participants with available data were included in the analysis.

Creatine kinase myocardial isoenzyme (CK-MB) values measured within 24 hours of anesthesia were to be collected when available.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=47 Participants Adult patients requiring general anesthesia for surgery
Creatine Kinase Myocardial Isoenzyme (if Available)	34.0 U/L Standard Deviation 12.3

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the operation

Population: All participants with available data were included in the analysis. n=the number of participants with available data at given time point.

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1364 Participants Adult patients requiring general anesthesia for surgery
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (T1-T0; n=1363)	-0.017 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (T2-T0; n=1363)	-0.072 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (T3-T0; n=1361)	-0.111 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (T4-T0; n=1340)	-0.165 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (Minimum-T0; n=1364)	-0.168 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (Maximum-T0; n=1364)	-0.078 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (T1-T0; n=1363)	-0.054 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (T2-T0; n=1363)	-0.103 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (T3-T0; n=1361)	-0.031 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (T4-T0; n=1340)	-0.010 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (Minimum-T0; n=1364)	-0.181 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (Maximum-T0; n=1364)	-0.071 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (T1-T0; n=1340)	-0.038 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (T2-T0; n=1340)	-0.100 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (T3-T0; n=1336)	-0.062 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (T4-T0; n=1341)	-0.111 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (Minimum-T0; n=1341)	-0.180 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (Maximum-T0; n=1340)	-0.083 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (T1-T0; n=1363)	-0.214 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (T2-T0; n=1363)	-0.165 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (T3-T0; n=1353)	-0.215 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (T4-T0; n=1336)	-0.152 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (Minimum-T0; n=1362)	-0.194 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (Maximum-T0; n=1358)	-0.222 Spearman's correlation coefficient

SECONDARY outcome

Timeframe: Every minute after anesthesia was stopped until the patient was extubated and until the patient responded to a verbal command.

Population: All participants with available data at each time point were included in the analysis.

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1359 Participants Adult patients requiring general anesthesia for surgery
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Exp w/ inh anesthesia (time to extubation)	0.019 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Exp w/ inh anesthesia (time to awakening)	-0.142 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Exp w/ Sevorane (time to extubation)	0.016 Spearman's correlation coefficient
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Exp w/ Sevorane (time to awakening)	0.211 Spearman's correlation coefficient

Adverse Events

Adults Requiring Anesthesia for Surgery

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adults Requiring Anesthesia for Surgery n=1365 participants at risk Adult patients requiring general anesthesia for surgery
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Injury, poisoning and procedural complications Operative Hemorrhage	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.

Other adverse events

Measure	Adults Requiring Anesthesia for Surgery n=1365 participants at risk Adult patients requiring general anesthesia for surgery
Injury, poisoning and procedural complications Unwanted Awareness During Anesthesia	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Gastrointestinal disorders Nausea	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Gastrointestinal disorders Vomiting	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Nervous system disorders Cognitive Disorders	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Nervous system disorders Dizziness	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
General disorders Hyperthermia	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Psychiatric disorders Psychomotor Hyperactivity	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.
Injury, poisoning and procedural complications Endotracheal Intubation Complication	0.07% 1/1365 • Physicians were to report all adverse events occurring during the induction phase, maintenance phase, and recovery phase of surgery.

Additional Information

Global Medical Services

Abbott (Ukraine)

Phone: 1-800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER