Skip to main content
Clinical Trials/NCT01213602
NCT01213602CompletedNot Applicable

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

Hospital Universitari de Bellvitge1 site in 1 country85 target enrollmentStarted: February 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
85
Locations
1
Primary Endpoint
Sevoflurane requirements

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

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.-

Outcomes

Primary Outcomes

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 Outcomes

  • Intraoperative and postoperative opiates requirements and relations with CVI(Time surgery and 24,48 and 72 h postoperative)

Investigators

Sponsor
Hospital Universitari de Bellvitge
Sponsor Class
Other

Study Sites (1)

Loading locations...

Similar Trials

Bilateral Bispectral Index... | Clinical Trial