AAI Index Clinical Trial
— MoDAOfficial title:
A Comparison of Efficacy of Clinical Parameters With Auditory Evoked Potentials in Monitoring of Adequate Course of General Anesthesia
| Verified date | October 2017 |
| Source | Military Institute of Medicine, Poland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 208 |
| Est. completion date | July 14, 2014 |
| Est. primary completion date | August 30, 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 61 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Department of Anesthesiology and Intensive Therapy | Warsaw |
| Lead Sponsor | Collaborator |
|---|---|
| Military Institute of Medicine, Poland |
Poland,
Ghoneim MM, Block RI, Haffarnan M, Mathews MJ. Awareness during anesthesia: risk factors, causes and sequelae: a review of reported cases in the literature. Anesth Analg. 2009 Feb;108(2):527-35. doi: 10.1213/ane.0b013e318193c634. Review. — View Citation
Lu J, Nelson LE, Franks N, Maze M, Chamberlin NL, Saper CB. Role of endogenous sleep-wake and analgesic systems in anesthesia. J Comp Neurol. 2008 Jun 1;508(4):648-62. doi: 10.1002/cne.21685. — View Citation
Nelson LE, Guo TZ, Lu J, Saper CB, Franks NP, Maze M. The sedative component of anesthesia is mediated by GABA(A) receptors in an endogenous sleep pathway. Nat Neurosci. 2002 Oct;5(10):979-84. — View Citation
Osterman JE, Hopper J, Heran WJ, Keane TM, van der Kolk BA. Awareness under anesthesia and the development of posttraumatic stress disorder. Gen Hosp Psychiatry. 2001 Jul-Aug;23(4):198-204. — View Citation
Saper CB, Chou TC, Scammell TE. The sleep switch: hypothalamic control of sleep and wakefulness. Trends Neurosci. 2001 Dec;24(12):726-31. Review. — View Citation
Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-9, table of contents. — View Citation
Wang DS, Orser BA. Inhibition of learning and memory by general anesthetics. Can J Anaesth. 2011 Feb;58(2):167-77. doi: 10.1007/s12630-010-9428-8. Epub 2010 Dec 23. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |