Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

Bilateral Bispectral Index Changes During Knee Replacement Surgery With and Without Femoral Block

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.

Study Overview

• Status: Completed
• Conditions: Knee Replacement Surgery

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Antoni Sabate Pes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Intraoperative and postoperative opiates requirements and relations with CVI	Time surgery and 24,48 and 72 h postoperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 1, 2010
• First Submitted That Met QC Criteria: October 1, 2010
• First Posted (Estimate): October 4, 2010

Study Record Updates

• Last Update Posted (Estimate): July 25, 2011
• Last Update Submitted That Met QC Criteria: July 22, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Trauma patients
• Other Study ID Numbers: SAB-ANE-2010-01