HydrocephalusBIS1NCT02575105
BIS Monitoring of Patients With Hydrocephalus
An observational study of Hydrocephalus, run by Suez Canal University.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 month to 65 years
- Conditions the study is for
- Hydrocephalus
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2008to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: . 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.
Inclusion 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.
Exclusion Criteria: Patients with Liver disease
About this study
Official title: Bispectral Index Monitoring of Propofol Anesthesia in Patients With Hydrocephalus. A Prospective Observational Study
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
Read the detailed description
Context: Enlarged skull circumference in patients with hydrocephalus might alter bispectral index (BIS) values; as distorted skull contour distances sensors from a shifted cerebral mass as well as mental dysfunction as a result of disrupted Cerebrospinal fluid circulation.
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
- Hydrocephalus
- Keywords
- Bispectral Index Hydrocephalus
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Bispectral Index Value
Might be statistically different
Measured: Duration of Surgical Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou Medical University
- Responsible party
- Principal investigator, Ashraf Dahaba, MD, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575105
- Sponsor's protocol ID
- MUGraz
- Acronym
- BIS1
- Status last verified
- Jun 2019
- First submitted
- 10 Oct 2015
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16115989Dahaba 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.
PubMed 17698861Dahaba 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.
PubMed 20179501Dahaba 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.
PubMed 25279677
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index Monitoring of Propofol Anesthesia in Patients With Hydrocephalus. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02575105
- Acronym / sponsor ID
- BIS1 / MUGraz
- Conditions
- Hydrocephalus
- Keywords
- Bispectral Index Hydrocephalus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Collaborators
- Wenzhou Medical University
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Context: Enlarged skull circumference in patients with hydrocephalus might alter bispectral index (BIS) values; as distorted skull contour distances sensors from a shifted cerebral mass as well as mental dysfunction as a result of disrupted Cerebrospinal fluid circulation.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 month to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- . 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Bispectral Index Value
Time frame: Duration of Surgical Operation
Might be statistically different
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Background: PubMed 16115989Dahaba 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.
- Background: PubMed 17698861Dahaba 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.
- Background: PubMed 20179501Dahaba 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.
- Background: PubMed 25279677Dahaba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by Suez Canal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Bispectral Index Value (time frame: Duration of Surgical Operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02575105, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.