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Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

Sponsor
Hospital Universitari de Bellvitge (Other)
Overall Status
Completed
CT.gov ID
NCT01213602
Collaborator
(none)
85
Enrollment
1
Location
12
Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The principal objective is to notice the relevance of timing performance of femoral block for knee replacement surgery during general anesthesia and analyze the relationship with bilateral bispectral index (BIS) monitoring during induction and maintenance of anesthesia. Otherwise the investigators try to investigate if the timing of performance of this block influence in postoperative variables as pain or blood loss.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    85 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Bilateral Bispectral Index Changes During Knee Replacement Surgery With and Without Femoral Block
    Study Start Date :
    Feb 1, 2010
    Actual Primary Completion Date :
    Feb 1, 2011
    Actual Study Completion Date :
    Feb 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Femoral block preoperative

    In one group (T1) with performance of femoral block before general anesthesia and administration of bolus of local anesthetic through stimulating catheter (combined anesthesia)
    Femoral block postoperative

    In second group (T2) with a administration of local anesthetic through stimulating femoral catheter until awareness of patient (balanced anesthesia).

    Outcome Measures

    Primary Outcome Measures

    1. Sevoflurane requirements [6 months]

      Combined ( femoral block and general anesthesia) or balanced anesthesia ( intravenous analgesics and general anesthesia) is evaluated on the requirements of inhalational hypnotics during surgery. Schedule time when BIS has to be in proper range (40-60): T1 T2 T3 T4 T5 T6 T1 Induction T2 Inflated cuff ischemia T3 Incision T4 Unlocking cuff ischemia T5 End surgery T6 Time to wake the patient from the close of the sevoflurane vaporizer Each time include a period of adjustment in 5 minutes

    Secondary Outcome Measures

    1. Intraoperative and postoperative opiates requirements and relations with CVI [Time surgery and 24,48 and 72 h postoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Exclusion Criteria:

    ASA IV, patients with difficult airway management, patients with antecedent of cerebral ischemia, presence of atrioventricular fistula, patients with absent distal pulses or history of vascular surgery in the involved limbs, patients with high risk of deep vein thrombosis.-

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Antoni Sabate Pes Hospitalet de Llobregat Barcelona Spain 08907

    Sponsors and Collaborators

    • Hospital Universitari de Bellvitge

    Investigators

    • Principal Investigator: Antoni Sabate Pes, MD PhD DEEA, Hospital Universitari Bellvitge

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01213602
    Other Study ID Numbers:
    • SAB-ANE-2010-01
    First Posted:
    Oct 4, 2010
    Last Update Posted:
    Jul 25, 2011
    Last Verified:
    Feb 1, 2011
    Keywords provided by , ,
    Trauma patients

    Study Results

    No Results Posted as of Jul 25, 2011