Trial Outcomes & Findings for 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 (NCT NCT01282203)

NCT ID: NCT01282203

Last Updated: 2013-03-04

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: 1122 participants
• Primary outcome timeframe: Up to 10 minutes
• Results posted on: 2013-03-04

Participant Flow

Participant milestones

Measure	Adults Requiring Anesthesia for Surgery Adult patients requiring general anesthesia for surgery
Overall Study STARTED	1122
Overall Study COMPLETED	1121
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Adults Requiring Anesthesia for Surgery Adult patients requiring general anesthesia for surgery
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Adults Requiring Anesthesia for Surgery n=1122 Participants Adult patients requiring general anesthesia for surgery
Age Continuous	45.1 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	619 Participants n=5 Participants
Sex: Female, Male Male	503 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 10 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=945 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Time to Loss of Consciousness of Patients Administered Anesthesia	2.7 Minutes Standard Deviation 1.4	—	—

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=1116 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Time to Awakening of Patients	15.4 Minutes Standard Deviation 19.8	—	—

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=1010 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Time to Extubation of Patients	65.7 Minutes Standard Deviation 127.5	—	—

PRIMARY outcome

Timeframe: Day 1

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

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).

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1116 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Anesthesiologists' Satisfaction With Using Sevorane for Induction and Maintenance Anesthesia	9.2 units on a scale Standard Deviation 1.1	—	—

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=1114 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Patients' Overall Impression of Anesthesia With Sevorane Excellent	476 Participants	—	—
Patients' Overall Impression of Anesthesia With Sevorane Positive	627 Participants	—	—
Patients' Overall Impression of Anesthesia With Sevorane Indifferent	11 Participants	—	—
Patients' Overall Impression of Anesthesia With Sevorane Other	0 Participants	—	—

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the surgery

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

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=995 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Systolic Blood Pressure Before anesthesia	137.5 mm Hg Standard Deviation 23.9	—	—
Systolic Blood Pressure Induction anesthesia (after intubation)	125.3 mm Hg Standard Deviation 22.3	—	—
Systolic Blood Pressure After surgical incision	117.6 mm Hg Standard Deviation 17.8	—	—
Systolic Blood Pressure After extubation	125.5 mm Hg Standard Deviation 14.1	—	—
Systolic Blood Pressure One hour after surgery	124.2 mm Hg Standard Deviation 12.5	—	—

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the surgery

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

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=995 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Diastolic Blood Pressure Before anesthesia	84.7 mm Hg Standard Deviation 13.4	—	—
Diastolic Blood Pressure Induction anesthesia (after intubation)	78.5 mm Hg Standard Deviation 30.2	—	—
Diastolic Blood Pressure After surgical incision	73.2 mm Hg Standard Deviation 12.3	—	—
Diastolic Blood Pressure After extubation	77.9 mm Hg Standard Deviation 11.7	—	—
Diastolic Blood Pressure One hour after surgery	76.9 mm Hg Standard Deviation 10.5	—	—

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the surgery

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

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=973 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Mean Arterial Pressure Before anesthesia	103.9 mm Hg Standard Deviation 17.9	—	—
Mean Arterial Pressure Induction anesthesia (after intubation)	95.3 mm Hg Standard Deviation 18.0	—	—
Mean Arterial Pressure After surgical incision	89.5 mm Hg Standard Deviation 15.0	—	—
Mean Arterial Pressure After extubation	95.5 mm Hg Standard Deviation 13.0	—	—
Mean Arterial Pressure One hour after surgery	95.0 mm Hg Standard Deviation 12.1	—	—

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the surgery

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

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=983 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Heart Rate Before anesthesia	83.4 beats per minute Standard Deviation 14.9	—	—
Heart Rate Induction anesthesia (after intubation)	81.9 beats per minute Standard Deviation 15.0	—	—
Heart Rate After surgical incision	79.1 beats per minute Standard Deviation 13.5	—	—
Heart Rate After extubation	82.8 beats per minute Standard Deviation 10.4	—	—
Heart Rate One hour after surgery	79.2 beats per minute Standard Deviation 9.0	—	—

SECONDARY outcome

Timeframe: During induction and maintenance of anesthesia

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=1057 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Blockades (induction)	9 Participants	—	—
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Blockades (maintenance)	12 Participants	—	—
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Extrasystoles (induction)	3 Participants	—	—
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Extrasystoles (maintenance)	10 Participants	—	—
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Arrhythmia (induction)	8 Participants	—	—
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Arrhythmia (maintenance)	21 Participants	—	—
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Myocardial ischemia (induction)	70 Participants	—	—
Presence of Deviations in Electrocardiogram Assessments During Anesthesia Myocardial ischemia (maintenance)	74 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 24 hours after anesthesia

Population: No data were available for the creatine kinase myocardial isoenzyme outcome measure.

Creatine kinase myocardial isoenzyme values measured within 24 hours of anesthesia were to be collected when available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before starting anesthesia to one hour after the surgery

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

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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1121 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (T4 -T0; n=1105)	0.131 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (Minimum -T0; n=1120)	0.213 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (Maximum -T0; n=1120)	0.153 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (T1-T0; n=1119)	0.289 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (T2-T0; n=1119)	0.243 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (T3-T0; n=1005)	0.203 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (T4-T0; n=1105)	0.196 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (Minimum-T0; n=1118)	0.288 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Diastolic blood pressure (Maximum-T0; n=1118)	0.163 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (T1-T0; n=1101)	0.308 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (T2-T0; n=1102)	0.250 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (T3-T0; n=988)	0.199 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (T4-T0; n=1084)	0.196 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (Minimum-T0; n=1099)	0.288 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Mean arterial blood pressure (Maximum-T0; n=1099)	0.177 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (T1-T0; n=1117)	0.269 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (T2-T0; n=1116)	0.245 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (T3-T0; n=995)	-0.040 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (T4-T0; n=1101)	-0.030 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (Minimum-T0; n=1115)	0.223 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Heart rate (Maximum-T0; n=1116)	0.120 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (T1- T0; n=1121)	0.271 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (T2-T0; n=1121)	0.207 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Hemodynamic Parameters During Anesthesia Systolic blood pressure (T3 -T0; n=1005)	0.143 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 (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.

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=1116 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane Duration of experience with Sevorane.
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Exp w/ inh anesthesia (time to extubation; n=1010)	-0.720 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Exp w/ inh anesthesia (time to awakening; n=1116)	-0.415 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Exp w/ Sevorane (time to extubation; n=1010)	-0.681 Spearman's correlation coefficient	—	—
Correlation Between Anesthesiologists' Clinical Experience and Time to Extubation and Awakening Exp w/ Sevorane (time to awakening; n=1116)	-0.294 Spearman's correlation coefficient	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Number of anesthesiologists participating in study.

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.)

Outcome measures

Measure	Adults Requiring Anesthesia for Surgery n=12 Participants Adult patients requiring general anesthesia for surgery	Inhalation Anesthesia n=12 Participants Duration of experience with inhalation anesthesia.	Anesthesia With Sevorane n=12 Participants Duration of experience with Sevorane.
Anesthesiologists' Duration of Clinical Experience With Anesthesia	17.8 years Standard Deviation 9.2	15.4 years Standard Deviation 11.6	3.5 years Standard Deviation 2.5

Adverse Events

Adults Requiring Anesthesia for Surgery

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adults Requiring Anesthesia for Surgery n=1122 participants at risk Adult patients requiring general anesthesia for surgery
Cardiac disorders Ventricular fibrillation	0.18% 2/1122 • 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.
Cardiac disorders Cardiac failure acute	0.09% 1/1122 • 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.
Cardiac disorders Myocardial infarction	0.09% 1/1122 • 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.
Cardiac disorders Atrial fibrillation	0.09% 1/1122 • 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.
Cardiac disorders Cardiac arrest	0.09% 1/1122 • 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.
Vascular disorders Hypertension	0.09% 1/1122 • 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.
Injury, poisoning and procedural complications Post-procedural hemorrhage	0.09% 1/1122 • 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.
Investigations Hypokalemia	0.09% 1/1122 • 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.

Other adverse events

Measure	Adults Requiring Anesthesia for Surgery n=1122 participants at risk Adult patients requiring general anesthesia for surgery
Vascular disorders Blood pressure increased	0.09% 1/1122 • 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.

Additional Information

Global Medical Services

AbbVie (prior sponsor Abbott)

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