BIS Monitoring of Patients With Hydrocephalus
BIS1
Bispectral Index Monitoring of Propofol Anesthesia in Patients With Hydrocephalus. A Prospective Observational Study
1 other identifier
observational
60
0 countries
N/A
Brief Summary
We tested the hypothesis that BIS values are altered in pediatric patients with hydrocephaly. We also tested the hypothesis that BIS values are altered in adult post cerebral hemorrhage patients with hydrocephaly undergoing ventricular-peritoneal shunt placement
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2008
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 10, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedJune 24, 2019
June 1, 2019
2.6 years
October 10, 2015
June 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Bispectral Index Value
Might be statistically different
Duration of Surgical Operation
Study Arms (4)
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.
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.
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
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
Eligibility Criteria
. 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. 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.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Suez Canal Universitylead
- Wenzhou Medical Universitycollaborator
Related Publications (4)
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.
PMID: 16115989BACKGROUNDDahaba 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.
PMID: 17698861BACKGROUNDDahaba 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.
PMID: 20179501BACKGROUNDDahaba 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.
PMID: 25279677BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doz. Dr.
Study Record Dates
First Submitted
October 10, 2015
First Posted
October 14, 2015
Study Start
May 1, 2008
Primary Completion
December 1, 2010
Study Completion
May 1, 2011
Last Updated
June 24, 2019
Record last verified: 2019-06