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Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT01213602
First received: October 1, 2010
Last updated: July 22, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Knee Replacement Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bilateral Bispectral Index Changes During Knee Replacement Surgery With and Without Femoral Block

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Sevoflurane requirements [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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:
  • Intraoperative and postoperative opiates requirements and relations with CVI [ Time Frame: Time surgery and 24,48 and 72 h postoperative ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ASA physical status I-III patients scheduled for total knee arthoplasty

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213602

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Hospital Universitari de Bellvitge, Anesthesiology Department
ClinicalTrials.gov Identifier: NCT01213602     History of Changes
Other Study ID Numbers: SAB-ANE-2010-01
Study First Received: October 1, 2010
Last Updated: July 22, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari de Bellvitge:
Trauma patients

ClinicalTrials.gov processed this record on May 22, 2013