AAI Index, Monitoring of Depth of Anesthesia
Conditions
Brief summary
Clinical monitoring is the most common method of adjustment of the appropriate level of general anesthesia. However, the episodes of intraoperative awareness are still reported, suggesting that clinical observations may not be sufficient in some cases. The objective of the study was to compare the efficacy of clinical and instrumental neuromonitoring with auditory evoked potentials in intraoperative analysis of the proper level of general anesthesia. The patients scheduled for elective surgery were included into the study, and randomly divided into two groups. Patients in the first group (TIVA group) underwent intravenous, in the second group (VA group) underwent volatile anesthesia. The adequacy of anesthesia was analyzed with standard clinical parameters. All the participants were instrumentally monitored with AAI index. After the anesthesia patients received a questionnaire with the questions regarding possible intraoperative awareness.
Interventions
OTHERmonitoring of the proper level of general anesthesia
The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.
Sponsors
Military Institute od Medicine National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
During the anesthesia, in all the participants an AAI-A line ARX index was continuously monitored. The electrodes were placed after the induction of anesthesia. Intraoperatively, both auditory evoked potentials with AAI index and electroencephalogram with burst suppression analysis was recorded. Recorded data were blinded for anesthesiologists, so were not used for analysis of level of anesthesia during surgery.
Intervention model description
Participants are assigned to intravenous or volatile anesthesia. In both groups both the clinical and instrumental monitoring of the proper level of anesthesia was analyzed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 61 Years
Healthy volunteers
Yes
Inclusion criteria
* patients scheduled for ENT procedures or discectomy, * preoperative health status I or II according to ASA score.
Exclusion criteria
* patients below 18 or above 61 year old, * ASA status III or higher, * patients suffering from: (i) hearing problems or tinnitus, (ii) chronic inflammation of the ear, (iii) epilepsy, and (iv) mental disorders, * pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in AAI values in selected (16) time points. | T1: after premedication, just before the onset of anesthesia; T2: 30 seconds after intravenous administration of propofol; T3: just before the endotracheal intubation; T4: 60 seconds after the endotracheal intubation; T5: 5 minutes after the endotracheal |
Countries
Poland
Outcome results
None listed