BIS Monitoring of Patients With Hydrocephalus

Hydrocephalus Clinical Trial

— BIS1  

Official title:

Bispectral Index Monitoring of Propofol Anesthesia in Patients With Hydrocephalus. A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575105
• Other study ID #: MUGraz
• Status: Completed
• Start date: May 2008
• Est. completion date: May 2011

Study information

• Verified date: June 2019
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Suez Canal University	Wenzhou Medical University

References & Publications (4)

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. — View Citation

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. Epub 2007 Aug 14. — View Citation

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. — View Citation

Dahaba AA. Different conditions that could result in the bispectral index indicating an incorrect hypnotic state. Anesth Analg. 2005 Sep;101(3):765-73. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Bispectral Index Value	Might be statistically different	Duration of Surgical Operation