We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213602
First Posted: October 4, 2010
Last Update Posted: July 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Universitari de Bellvitge
  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:


Further study details as provided by Hospital Universitari de Bellvitge:

Primary Outcome Measures:
  • Sevoflurane requirements [ Time Frame: 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:
  • Intraoperative and postoperative opiates requirements and relations with CVI [ Time Frame: Time surgery and 24,48 and 72 h postoperative ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hospital Universitari de Bellvitge, Anesthesiology Department
ClinicalTrials.gov Identifier: NCT01213602     History of Changes
Other Study ID Numbers: SAB-ANE-2010-01
First Submitted: October 1, 2010
First Posted: October 4, 2010
Last Update Posted: July 25, 2011
Last Verified: February 2011

Keywords provided by Hospital Universitari de Bellvitge:
Trauma patients