Trial Outcomes & Findings for Closed Loop Isoflurane Administration With Bispectral Index in Open Heart Surgery (NCT NCT01069562)
NCT ID: NCT01069562
Last Updated: 2011-02-21
Results Overview
The duration of time depth of anesthesia was maintained in the recommended range (as measured by BIS) during the period isoflurane (general anesthetic) was administered to the study population. This value expressed as percentage is the primary outcome. BIS is an objective measure of depth of anesthesia derived from statistical(bispectral) analysis of electroencephalographic waves. BIS ranges from 0 to 100. It decreases monotonically from 100 in the awake state to lower values with sedation and anesthesia.
COMPLETED
NA
40 participants
8 hours (approximately)
2011-02-21
Participant Flow
The recruitment of participants started on 10th January 2009 and ended on 24th June 2010. All patients recruited were admitted for elective cardiac surgery in the Cardio Thoracic Surgery ward in Post Graduate Institute of Medical Education and Research, Chandigarh, India.
All the patients who were enrolled were randomized to the two study arms.
Participant milestones
| Measure |
Manual
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Closed Loop Isoflurane Administration With Bispectral Index in Open Heart Surgery
Baseline characteristics by cohort
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
46.4 years
STANDARD_DEVIATION 15.2 • n=93 Participants
|
46.4 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
46.4 years
STANDARD_DEVIATION 14.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Region of Enrollment
India
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The duration of time depth of anesthesia was maintained in the recommended range (as measured by BIS) during the period isoflurane (general anesthetic) was administered to the study population. This value expressed as percentage is the primary outcome. BIS is an objective measure of depth of anesthesia derived from statistical(bispectral) analysis of electroencephalographic waves. BIS ranges from 0 to 100. It decreases monotonically from 100 in the awake state to lower values with sedation and anesthesia.
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50
|
75.9 percentage of time
Standard Deviation 11.2
|
84.6 percentage of time
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '\_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-\_). The median value of all performance errors during isoflurane anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Median Performance Error (MDPE)
|
7.5 percentage deviation of BIS from target
Standard Deviation 7.3
|
4.8 percentage deviation of BIS from target
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Median Absolute Performance Error (MDAPE)
|
13.2 percentage deviation of absolute BIS
Standard Deviation 3.7
|
11.0 percentage deviation of absolute BIS
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Wobble
|
9.3 percentage of BIS
Standard Deviation 3.5
|
8.7 percentage of BIS
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The duration of time heart rate remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Percentage of Time Heart Rate Remained Within 25% of Pre-op Baseline
|
77.3 percentage of time
Standard Deviation 17.6
|
86.1 percentage of time
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The duration of time mean arterial pressure remained within 25% of the pre-operative baseline value during the period isoflurane (general anesthetic) was administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Percentage of Time Mean Arterial Pressure Remained Within 25% of Pre-op Baseline
|
76.0 percentage of time
Standard Deviation 17.2
|
80.4 percentage of time
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 3 days (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The number of patients who were able to recall the intra-operative events when assessed postoperatively. This was assessed by a structured protocol
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Intra-operative Awareness
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The total amount of fentanyl that was used during the procedure.
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Fentanyl Used
|
10.1 µg/kg
Standard Deviation 1.4
|
10.1 µg/kg
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The amount of adrenaline used during the procedure
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Intra Operative Adrenaline Used
|
2.6 µg/kg
Standard Deviation 0.4
|
2.7 µg/kg
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 8 hours (approximately)Population: All the patients who were randomized completed the study protocol and were included for analysis
The amount of phenylephrine used during the procedure.
Outcome measures
| Measure |
Manual
n=20 Participants
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 Participants
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
INTRA OPERATIVE PHENYLEPHRINE USED
|
5.2 .µg/kg
Standard Deviation 1.4
|
4.5 .µg/kg
Standard Deviation 1.5
|
Adverse Events
Manual
IAADS Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Manual
n=20 participants at risk
The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
|
IAADS Group
n=20 participants at risk
In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
|
|---|---|---|
|
Cardiac disorders
High inotropic requirement intra-op
|
15.0%
3/20 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
Additional Information
Puri GD
Post Graduate Institute of Medical Education and Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place