Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
208 participants
INTERVENTIONAL
2012-04-20
2014-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TIVA group
The participants scheduled for elective ENT procedures or for elective discectomy. The surgery was performed under totally intravenous anesthesia.
During procedure, monitoring of the proper level of general anesthesia both clinical and instrumental was performed.
monitoring of the proper level of general anesthesia
The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.
VA group
The participants scheduled for elective ENT procedures or for elective discectomy. The surgery was performed under volatile anesthesia. During procedure, monitoring of the proper level of general anesthesia both clinical and instrumental was performed.
monitoring of the proper level of general anesthesia
The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
monitoring of the proper level of general anesthesia
The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* preoperative health status I or II according to ASA score.
Exclusion Criteria
* 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.
18 Years
61 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Military Institute od Medicine National Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dariusz Tomaszewski
Adjunct professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Anesthesiology and Intensive Therapy
Warsaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Saper CB, Chou TC, Scammell TE. The sleep switch: hypothalamic control of sleep and wakefulness. Trends Neurosci. 2001 Dec;24(12):726-31. doi: 10.1016/s0166-2236(00)02002-6.
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. doi: 10.1038/nn913.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06101968-05
Identifier Type: -
Identifier Source: org_study_id