Clinical trial NCT03331692: Monitoring of Adequate Course of General Anesthesia
Official title: A Comparison of Efficacy of Clinical Parameters With Auditory Evoked Potentials in Monitoring of Adequate Course of General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Monitoring of Depth of Anesthesia
AAI Index
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in AAI values in selected (16) time points.
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Anesthesiology and Intensive Therapy
Study officials:
References:
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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.
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):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.
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. doi: 10.1016/s0163-8343(01)00142-6.