Study Results
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Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2008-05-31
2011-05-31
Brief Summary
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Detailed Description
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Objectives: Investigators tested the hypothesis that BIS values are altered in pediatric patients with hydrocephaly. Investigators also tested the hypothesis that BIS values are altered in adult post cerebral hemorrhage patients with hydrocephaly undergoing ventricular-peritoneal shunt placement.
Methods: After ethics committee approval participants, or their next of kin, who gave written informed consent were recruited in the study. Investigators excluded potential participants suffering from hepatic disease. In the first study 15 pediatric patients with hydrocephaly and 15 pediatric control patients at approximately the same age group were included in the study.
In the second study 15 post cerebral hemorrhage adult patients undergoing ventricular-peritoneal shunt placements and 15 adult control patients were included in the study.
2 BIS sensors were placed on patients' forehead and connected to BIS-Vista monitors. In a quiet anesthesia induction room investigators recorded BIS-Vista for 10 min before induction.
Remifentanil 4 ng ml-1 was started and propofol TCI was kept constant at 4 microg ml-1 with no adjustments for a 1 h anesthesia maintenance study-recording period when time of surgery allowed. Investigators also noted BIS values immediately before and after a patent ventricular-peritoneal shunt was successfully installed. After conclusion of surgical procedures, remifentanil and propofol infusions were terminated and this marked the beginning of the recovery phase of the study where we recorded BIS values for another 20 min emergence from anesthesia.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Pediatric Hydrocephalus
In the first study 15 pediatric patients with hydrocephaly and 15 pediatric control patients at approximately the same age group will be included in the study.
No interventions assigned to this group
Pediatric Control
In the first study 15 pediatric patients with hydrocephaly and 15 pediatric control patients at approximately the same age group will be included in the study.
No interventions assigned to this group
Adult Hydrocephalus
In the second study 15 post cerebral hemorrhage adult patients undergoing ventriculo-peritoneal shunt placements and 15 adult control patients will be included in the study
No interventions assigned to this group
Adult Control
In the second study 15 post cerebral hemorrhage adult patients undergoing ventriculo-peritoneal shunt placements and 15 adult control patients will be included in the study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1 Month
65 Years
ALL
No
Sponsors
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Wenzhou Medical University
OTHER
Suez Canal University
OTHER
Responsible Party
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Ashraf Dahaba, MD
Doz. Dr.
References
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Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg. 2005 Sep;101(3):765-773. doi: 10.1213/01.ane.0000167269.62966.af.
Dahaba AA, Worm HC, Zhu SM, Bao FP, Salah A, Zakaria S, Bornemann H, Stadlbauer V, Rehak PH, Metzler H, Stauber RE. Sensitivity and specificity of bispectral index for classification of overt hepatic encephalopathy: a multicentre, observer blinded, validation study. Gut. 2008 Jan;57(1):77-83. doi: 10.1136/gut.2007.129130. Epub 2007 Aug 14.
Dahaba AA, Xue JX, Zhao GG, Liu QH, Xu GX, Bornemann H, Rehak PH, Metzler H. BIS-vista occipital montage in patients undergoing neurosurgical procedures during propofol-remifentanil anesthesia. Anesthesiology. 2010 Mar;112(3):645-51. doi: 10.1097/ALN.0b013e3181cf4111.
Dahaba AA, Lin H, Ye XF, Lin J, Zhang N, Lian QQ. Bispectral index monitoring of propofol anesthesia in pediatric patients with hydrocephalus. A prospective observational study. Paediatr Anaesth. 2014 Nov;24(11):1190-2. doi: 10.1111/pan.12508. No abstract available.
Other Identifiers
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MUGraz
Identifier Type: -
Identifier Source: org_study_id
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