Trial Outcomes & Findings for Automatic Control of Total Intravenous Anesthesia (ACTIVA) (NCT NCT04432974)
NCT ID: NCT04432974
Last Updated: 2024-10-04
Results Overview
The depth of hypnosis adequacy is assessed by evaluating, for each patient enrolled, the percentage of maintenance duration during which the Bispectral Index Scale (BIS) is kept within the recommended range from 40 to 60 (BIS \[40,60\]). The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study. The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the BIS is kept below 40 (BIS\<40) is also specified. Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds. The BIS ranges from 0 (absence of brain activity) to 100 (fully awake patient).
COMPLETED
NA
139 participants
During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.
2024-10-04
Participant Flow
The recruited patients were patients scheduled for elective plastic surgery for whom general anesthesia performed in TIVA was deemed appropriate. The recruitments took place at the Spedali Civili di Brescia hospital, in the plastic surgery operating room. The first participant was enrolled on July 2, 2019 and the last participant was enrolled on April 4, 2023.
Patients were approached and informed of the possibility to participate in the study during the preoperative anesthesia visit, which takes place two weeks before the scheduled surgical procedure. If the patient wishes to participate in the study, the informed consent is obtained on the day of surgery, at the patient's arrival in the preoperative holding area.
Participant milestones
| Measure |
ACTIVA
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Overall Study
STARTED
|
139
|
|
Overall Study
Operating Room Admission
|
139
|
|
Overall Study
Operating Room Discharge
|
139
|
|
Overall Study
Recovery Room Admission
|
139
|
|
Overall Study
Recovery Room Discharge
|
139
|
|
Overall Study
Ward 6 Hours Post-surgery
|
139
|
|
Overall Study
Ward 24 Hours Post-surgery
|
139
|
|
Overall Study
COMPLETED
|
139
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Age, Continuous
|
57 years
n=139 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=139 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=139 Participants
|
|
Region of Enrollment
Italy
|
139 Participants
n=139 Participants
|
|
Weight
|
70 kg
n=139 Participants
|
|
Height
|
165 cm
n=139 Participants
|
|
Mean arterial pressure
|
100 mmHg
n=139 Participants
|
|
Heart rate
|
71 beats per minute
n=139 Participants
|
|
ASA status
ASA 1
|
12 Participants
n=139 Participants
|
|
ASA status
ASA 2
|
96 Participants
n=139 Participants
|
|
ASA status
ASA 3
|
31 Participants
n=139 Participants
|
|
PONV risk
0
|
8 Participants
n=139 Participants
|
|
PONV risk
1
|
34 Participants
n=139 Participants
|
|
PONV risk
2
|
39 Participants
n=139 Participants
|
|
PONV risk
3
|
45 Participants
n=139 Participants
|
|
PONV risk
4
|
13 Participants
n=139 Participants
|
|
Type of surgery
Skin cancer exeresis
|
54 Participants
n=139 Participants
|
|
Type of surgery
Mastectomy
|
34 Participants
n=139 Participants
|
|
Type of surgery
Mastoplasty
|
28 Participants
n=139 Participants
|
|
Type of surgery
Surgical treatment of wounds
|
7 Participants
n=139 Participants
|
|
Type of surgery
Electrochemotherapy
|
7 Participants
n=139 Participants
|
|
Type of surgery
Lipofilling
|
5 Participants
n=139 Participants
|
|
Type of surgery
Eyelid surgery
|
2 Participants
n=139 Participants
|
|
Type of surgery
Rhinoplasty
|
1 Participants
n=139 Participants
|
|
Type of surgery
Brachioplasty
|
1 Participants
n=139 Participants
|
PRIMARY outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.The depth of hypnosis adequacy is assessed by evaluating, for each patient enrolled, the percentage of maintenance duration during which the Bispectral Index Scale (BIS) is kept within the recommended range from 40 to 60 (BIS \[40,60\]). The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study. The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the BIS is kept below 40 (BIS\<40) is also specified. Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds. The BIS ranges from 0 (absence of brain activity) to 100 (fully awake patient).
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Depth of Hypnosis Adequacy
BIS [40,60]
|
79.4 percentage of maintenance duration
Interval 68.6 to 87.1
|
|
Depth of Hypnosis Adequacy
BIS<40
|
16.2 percentage of maintenance duration
Interval 10.0 to 26.2
|
SECONDARY outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to the point at which the automatic control is turned off at the conclusion of surgery, an average of 2 hours.Number of participants for which the ACTIVA system showed dysfunctions. The results are presented in a table where each row indicates the type of dysfunction and the number of participants for which that particular type of dysfunction occurred.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Number of Participants for Which the System Showed Dysfunctions
Venous access occlusion
|
8 Participants
|
|
Number of Participants for Which the System Showed Dysfunctions
Infusion pumps failure
|
8 Participants
|
|
Number of Participants for Which the System Showed Dysfunctions
No system dysfunctions
|
123 Participants
|
SECONDARY outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to the point at which the automatic control is turned off at the conclusion of surgery, an average of 2 hours.Levels of satisfaction of the experimenter regarding three aspects of the ACTIVA system. The first aspect is the ease of use of the ACTIVA software and its infusion system. The second aspect is the behavior of the ACTIVA system during the induction phase of anesthesia. The third aspect is the behavior of the ACTIVA system during the maintenance phase of anesthesia. For each aspect, the level of satisfaction is expressed by the experimenter by assigning a score on a scale ranging from 0 (extremely unsatisfied) to 10 (extremely satisfied). Thus, higher values represent a better outcome. Note that the scoring scale employed is the same for each of the three aspects. The results are reported in a table divided in three rows, one for each aspect evaluated. Each row is divided in eleven categories representing the scores from 0 to 10. For each category it is indicated the number of patients for which the experimenter expressed that specific score.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 0
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 1
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 2
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 3
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 4
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 5
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 6
|
6 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 7
|
23 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 8
|
56 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 9
|
42 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
General level of satisfaction · 10
|
12 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 0
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 1
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 2
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 3
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 4
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 5
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 6
|
7 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 7
|
14 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 8
|
35 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 9
|
53 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia induction · 10
|
30 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 0
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 1
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 2
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 3
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 4
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 5
|
0 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 6
|
10 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 7
|
16 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 8
|
32 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 9
|
48 Participants
|
|
Levels of Satisfaction of the Experimenter Expressed as Number of Participants Who Have Received a Specific Score
Level of satisfaction regarding anesthesia maintenance · 10
|
33 Participants
|
SECONDARY outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.The effect of drugs delivery on heart rate is assessed by evaluating, for each patient enrolled, the percentage of the anesthesia maintenance duration in which the heart rate (HR) is kept inside the range from 50 to 100 beats per minute (HR \[50,100\]). The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study. The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the HR is kept below 50 (HR\<50) is also specified. Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Effect of Drugs Delivery on Heart Rate
HR [50,100]
|
99.7 percentage of maintanance duration
Interval 91.9 to 100.0
|
|
Effect of Drugs Delivery on Heart Rate
HR<50
|
0.3 percentage of maintanance duration
Interval 0.0 to 8.1
|
SECONDARY outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.The effect of drugs delivery on mean arterial pressure (MAP) is assessed by evaluating, for each patient enrolled, the anesthesia maintenance duration in which the non-invasively measured MAP is kept inside the range from 65 to 110 mmHg (MAP \[65,110\]). The outcome measure is defined as the median of these percentages calculated over all the patients enrolled in the study. The median of the percentages, calculated over all the patients enrolled in the study, of the anesthesia maintenance duration in which the MAP is kept below 65 (MAP\<65) is also specified. Maintenance duration is the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds. MAP is defined as diastolic pressure + 1/3(systolic pressure - diastolic pressure).
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Effect of Drugs Delivery on Mean Arterial Pressure (MAP)
MAP [65,110]
|
79.0 percentage of maintenance duration
Interval 63.1 to 92.1
|
|
Effect of Drugs Delivery on Mean Arterial Pressure (MAP)
MAP<65
|
15.7 percentage of maintenance duration
Interval 5.9 to 34.6
|
SECONDARY outcome
Timeframe: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.The postoperative heart rate is assessed by measuring the heart rate in beats per minute (bpm).
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Postoperative Heart Rate Stability
Operating room discharge
|
72 beats per minute
Interval 64.0 to 80.0
|
|
Postoperative Heart Rate Stability
Recovery room admission
|
74 beats per minute
Interval 67.0 to 80.0
|
|
Postoperative Heart Rate Stability
Recovery room discharge
|
74 beats per minute
Interval 65.0 to 80.0
|
|
Postoperative Heart Rate Stability
6 hours after surgery
|
74 beats per minute
Interval 65.0 to 80.0
|
|
Postoperative Heart Rate Stability
24 hours after surgery
|
72 beats per minute
Interval 68.0 to 80.0
|
SECONDARY outcome
Timeframe: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.The postoperative mean arterial pressure (MAP) stability is assessed by non-invasively measuring the MAP with an electronic sphygmomanometer trough an inflatable cuff. Mean arterial pressure (MAP) is defined as diastolic pressure + 1/3(systolic pressure - diastolic pressure).
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Postoperative Mean Arterial Pressure (MAP) Stability
Operating room discharge
|
82 mmHg
Interval 75.0 to 93.0
|
|
Postoperative Mean Arterial Pressure (MAP) Stability
Recovery room admission
|
83 mmHg
Interval 77.0 to 92.0
|
|
Postoperative Mean Arterial Pressure (MAP) Stability
Recovery room discharge
|
85 mmHg
Interval 78.0 to 92.0
|
|
Postoperative Mean Arterial Pressure (MAP) Stability
6 hours after surgery
|
90 mmHg
Interval 80.0 to 97.0
|
|
Postoperative Mean Arterial Pressure (MAP) Stability
24 hours after surgery
|
88 mmHg
Interval 80.0 to 97.0
|
SECONDARY outcome
Timeframe: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.The postoperative sedation is assessed by means of a Sedation Score scale. It is a 3 point scale from 0 (fully awake) to 3 (fully sedated)
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 0
|
97 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 1
|
40 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 2
|
2 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 3
|
0 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 0
|
115 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 1
|
24 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 2
|
0 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 3
|
0 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 0
|
135 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 1
|
4 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 2
|
0 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 3
|
0 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 0
|
139 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 1
|
0 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 2
|
0 Participants
|
|
Postoperative Sedation Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 3
|
0 Participants
|
SECONDARY outcome
Timeframe: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.Postoperative Nausea and Vomiting is assessed by means of the Bellville PONV scale. It is a 3 point scale from 0 (no nausea \& vomiting) to 3 (vomiting present)
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 2
|
0 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 3
|
1 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 0
|
136 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 1
|
3 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 2
|
0 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 3
|
0 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 0
|
133 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 1
|
4 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 2
|
1 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 3
|
1 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 0
|
135 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 1
|
4 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 2
|
0 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 3
|
0 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 0
|
136 Participants
|
|
Postoperative Nausea and Vomiting (PONV) Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 1
|
2 Participants
|
SECONDARY outcome
Timeframe: End of anesthesia (operating room discharge, recovery room admission, recovery room discharge), 6 hours after surgery, 24 hours after surgery.The postoperative analgesia is assessed using a 10-point numeric rating scale (NRS). It is a 10 point scale from 0 (no pain) to 10 (maximum pain).
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 0
|
92 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 1
|
4 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 2
|
7 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 3
|
6 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 4
|
13 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 5
|
6 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 6
|
3 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 7
|
5 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 8
|
2 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 9
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room admission · 10
|
1 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 0
|
74 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 1
|
6 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 2
|
16 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 3
|
18 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 4
|
7 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 5
|
6 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 6
|
5 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 7
|
6 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 8
|
1 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 9
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
Recovery room discharge · 10
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 0
|
71 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 1
|
12 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 2
|
17 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 3
|
18 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 4
|
12 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 5
|
4 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 6
|
3 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 7
|
2 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 8
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 9
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
6 hours after surgery · 10
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 0
|
88 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 1
|
18 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 2
|
12 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 3
|
9 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 4
|
7 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 5
|
4 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 6
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 7
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 8
|
1 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 9
|
0 Participants
|
|
Postoperative Analgesia Expressed as Number of Participants Who Have Received a Specific Score
24 hours after surgery · 10
|
0 Participants
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to the point at which the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds, an average of 110 seconds.The induction time is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Induction Time
|
103 seconds
Interval 79.0 to 162.0
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to 60 seconds following the induction time, an average of 170 seconds.The lowest Bispectral Index (BIS) is the lowest BIS value observed within the 60 seconds following the induction time. The BIS quantifies the cerebral activity and ranges from 99 (corresponding to a fully awake and aware patient) to 0 (corresponding to the absence of brain activity. For general anesthesia it is recommended to keep the BIS inside the range 40-60. Values above 60 represent a too light anesthesia while values below 40 represents a too deep anesthesia.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Lowest Bispectral Index (BIS) Induction
|
42 units on a scale (BIS)
Interval 36.0 to 45.0
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to the point at which the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds, an average of 170 seconds.Propofol dose administered by the system throughout the induction time.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Propofol Induction Dose
|
1.90 mg/kg
Interval 1.63 to 2.19
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to the point at which the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds, an average of 170 seconds.Remifentanil dose administered by the system throughout the induction time.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Remifentanil Induction Dose
|
2.16 ug/kg
Interval 1.73 to 2.61
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to the 5 minutes following the induction time, an average of 410 seconds.The lowest heart rate is the lowest heart rate value observed within the 5 minutes following the induction time.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Lowest Heart Rate Induction
|
54 beats per minute
Interval 48.0 to 59.0
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to the 5 minutes following the induction time, an average of 410 seconds.The lowest mean arterial pressure (MAP) is the lowest value of the MAP observed within the 5 minutes following the induction time. It is assessed by non-invasively measuring the MAP with an electronic sphygmomanometer embedded in a multiparametric patient monitor through an inflatable cuff. Mean arterial pressure (MAP) is defined as diastolic pressure + 1/3(systolic pressure - diastolic pressure).
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Lowest Mean Arterial Pressure (MAP) Induction
|
69 mmHg
Interval 58.0 to 76.0
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to the 5 minutes following the induction time, an average of 410 seconds.Number of Participants that showed the occurrence of a burst-suppression episode within the 5 minutes following the induction time. A burst-suppression episode is defined as a value of burst-suppression ratio (BSR) above 10% for at least 60 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Number of Participants With Burst-Suppression Episode Following Anesthesia Induction
|
6 Participants
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.The MDPE is the median performance error calculated during the maintenance phase. The performance error (PE) is calculated for each patient (i) and for each BIS sample (j) according to the formula: PEij=((BISij-BIS\_Target)/BIS\_Target)\*100, where BIS\_Target is set equal to 50. The MDPE is a measure of bias and describes whether the measured BIS values are systematically distributed either above or below the BIS target. The MDPE is calculated according to the formula: MDPEi=median{PEij}. The maintenance phase is defined as the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
MDPE
|
-10 percentage of target BIS value
Interval -16.0 to -6.0
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.The MDAPE is the median absolute performance error calculated during the maintenance phase. The performance error (PE) is calculated for each patient (i) and for each BIS sample (j) according to the formula: PEij=((BISij-BIS\_Target)/BIS\_Target)\*100, where BIS\_Target is set equal to 50. The MDAPE is a measure of inaccuracy. The MDAPE is calculated according to the formula: MDAPEi=median{\|PEij\|}. The maintenance phase is defined as the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
MDAPE
|
12 percentage of target BIS value
Interval 10.0 to 16.0
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.The WOBBLE is an index of time-related changes in the performance and measures the intra-patient variability in performance errors. It is calculated during the maintenance phase. The performance error (PE) is calculated for each patient (i) and for each BIS sample (j) according to the formula: PEij=((BISij BIS\_Target)/BIS\_Target)\*100, where BIS\_Target is set equal to 50. The WOBBLE is calculated according to the formula: WOBBLEi=median{\|PEij-MDPEi\|}. The maintenance phase is defined as the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
WOBBLE
|
8 percentage of target BIS value
Interval 6.0 to 10.0
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.The Global Score (GS) is a performance index that characterize the overall control performance. It is calculated as (MDAPE+WOBBLE)/BIS \[40,60\]. For each patient (i) and for each Bispectral Index Scale (BIS) sample (j): PEij=((BISij BIS\_Target)/BIS\_Target)\*100, with BIS\_Target=50. MDAPEi=median{\|PEij\|}. WOBBLEi=median{\|PEij-MDPEi\|}. BIS \[40,60\] is the percentage of the anesthesia maintenance duration in which the BIS is kept between 40 and 60. The maintenance phase is defined as the period of time that goes from the end of anesthesia induction, defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds, to the point at which the automatic control is turned off at the conclusion of surgery. The GS ranges from zero to infinity. The lower the GS, the better the control performance. Specifically, a GS value of zero would correspond to the case where the BIS is always maintained at its target value.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Global Score (GS)
|
26.3 Dimensionless
Interval 22.2 to 36.7
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.It is the median value of the propofol infusion rate administered by the ACTIVA system during the maintenance phase of anesthesia. The outcome measure is defined as the median of the propofol infusion rates administered by the ACTIVA system during the maintenance phase of anesthesia calculated over all the patients enrolled in the study. The maintenance phase is defined as the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Median Maintenance Propofol Infusion Rate
|
6.19 mg/kg/h
Interval 5.05 to 7.26
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.It is the median value of the remifentanil infusion rate administered by the ACTIVA system during the maintenance phase of anesthesia. The outcome measure is defined as the median of the remifentanil infusion rates administered by the ACTIVA system during the maintenance phase of anesthesia calculated over all the patients enrolled in the study. The maintenance phase is defined as the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Median Maintenance Remifentanil Infusion Rate
|
0.16 ug/kg/min
Interval 0.13 to 0.21
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.It is the median propofol effect-site concentration achieved by the ACTIVA system during the maintenance phase of anesthesia. It is estimated according to the Schnider model. The outcome measure is defined as the median of the propofol effect-site concentrations achieved by the ACTIVA system during the maintenance phase of anesthesia calculated over all the patients enrolled in the study. The maintenance phase is defined as the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Median Maintenance Propofol Effect-Site Concentration
|
2.72 ug/ml
Interval 2.41 to 3.18
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.It is the median remifentanil effect-site concentration achieved by the ACTIVA system during the maintenance phase of anesthesia. It is estimated according to the Minto model. The outcome measure is defined as the median of the remifentanil effect-site concentrations achieved by the ACTIVA system during the maintenance phase of anesthesia calculated over all the patients enrolled in the study. The maintenance phase is defined as the period of time that goes from the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Median Maintenance Remifentanil Effect-Site Concentration
|
5.02 ng/ml
Interval 4.21 to 6.25
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds to the point at which the automatic control is turned off (maintenance duration), an average of 2 hours.Number of Participants that showed the occurrence of a burst-suppression episode during the maintenance phase. A burst-suppression episode is defined as a value of burst-suppression ratio (BSR) above 10% for at least 60 seconds. The maintenance phase here is defined as the period of time that goes from the 5 minutes after the end of anesthesia induction to the point at which the automatic control is turned off at the conclusion of surgery. The end of anesthesia induction is defined as the time instant when the BIS drops below 60 for the first time and remains there for the subsequent 30 seconds.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Number of Participants With Burst-Suppression Episode During Anesthesia Maintenance
|
25 Participants
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is started to incision for the cases before incision. During anesthesia from incision to the time instant when the automatic control is stopped for the cases after incision.Number of Participants that showed cases of hypotension treated with ephedrine or etilefrine before and after the beginning of the surgical stimulation (incision).
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Number of Participants That Received Hemodynamic Interventions
Before incision
|
26 Participants
|
|
Number of Participants That Received Hemodynamic Interventions
After incision
|
71 Participants
|
POST_HOC outcome
Timeframe: During anesthesia from the time instant when the automatic control is stopped to when the patient is extubated, up to 11 minutes.The extubation time is the time interval that elapses from the time instant when the automatic control is stopped to when the patient is extubated. It is an indicator of the awakening time.
Outcome measures
| Measure |
ACTIVA
n=139 Participants
Participants received total intravenous anesthesia performed with the ACTIVA automatic control system.
|
|---|---|
|
Extubation Time
|
496 seconds
Interval 374.0 to 608.0
|
Adverse Events
ACTIVA
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Massimiliano Paltenghi
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place