Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

NCT01213602 | Completed DMC

• 1 other identifier: SAB-ANE-2010-01
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Replacement Surgery

Keywords

Trauma patients

Outcome Measures

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

  6 months

Secondary Outcomes (1)

• Intraoperative and postoperative opiates requirements and relations with CVI

  Time surgery and 24,48 and 72 h postoperative

Study Arms (2)

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 Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• 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.-

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Antoni Sabate Pes

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Study Officials

• Antoni Sabate Pes, MD PhD DEEA

  Hospital Universitari Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 25, 2011

Record last verified: 2011-02

Locations

ES (1)