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CompletedNCT01213602Updated Jul 25, 2011

Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

An observational study in Knee Replacement Surgery, sponsored by Hospital Universitari de Bellvitge. Completed at 1 site in Spain. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-07-25.

Sponsored by Hospital Universitari de Bellvitge · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
50 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Knee Replacement Surgery

Keywords

  • Trauma patients
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In context

Lead sponsor

Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility 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.-

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (actual)

Groups and 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).

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What researchers measure

Primary outcomes

  1. Sevoflurane requirements

    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

    Time frame: 6 months

Secondary outcomes

  1. Intraoperative and postoperative opiates requirements and relations with CVI

    Time frame: Time surgery and 24,48 and 72 h postoperative

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Study locations

1 site
  • Antoni Sabate Pes
    Hospitalet de Llobregat, Barcelona 08907, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01213602
Lead sponsor
Hospital Universitari de Bellvitge
First posted
Oct 4, 2010
Start date
Feb 2010
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Jul 25, 2011

Study contacts

Antoni Sabate Pes, MD PhD DEEA
principal investigator · Hospital Universitari Bellvitge

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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