BIS Monitoring of Patients With Hydrocephalus

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Brief Title

BIS Monitoring of Patients With Hydrocephalus

Official Title

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

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
    

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


Primary Outcome

Difference in Bispectral Index Value


Condition

Hydrocephalus


Study Arms / Comparison Groups

 Pediatric Hydrocephalus
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

May 2008

Completion Date

May 2011

Primary Completion Date

December 2010

Eligibility Criteria

        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
      

Gender

All

Ages

1 Month - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT02575105

Organization ID

MUGraz


Responsible Party

Principal Investigator

Study Sponsor

Suez Canal University

Collaborators

 Wenzhou Medical University

Study Sponsor

, , 


Verification Date

June 2019