Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

NCT ID: NCT01213602

Last Updated: 2011-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Replacement Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Femoral block postoperative

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

No interventions assigned to this group

Eligibility Criteria

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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.-
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari de Bellvitge

OTHER

Sponsor Role lead

Responsible Party

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Anesthesiology Department

Principal Investigators

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Antoni Sabate Pes, MD PhD DEEA

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Bellvitge

Locations

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Antoni Sabate Pes

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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SAB-ANE-2010-01

Identifier Type: -

Identifier Source: org_study_id

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