BIS Monitoring of Patients With Hydrocephalus (BIS1)

June 20, 2019 updated by: Ashraf Dahaba, MD, Suez Canal University

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Bispectral Index Value
Time Frame: Duration of Surgical Operation
Might be statistically different
Duration of Surgical Operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Collaborators

Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 10, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUGraz

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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