Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

Knee Replacement Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213602
• Other study ID #: SAB-ANE-2010-01
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: July 22, 2011
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Replacement Surgery

Locations

Country	Name	City	State
Spain	Antoni Sabate Pes	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Intraoperative and postoperative opiates requirements and relations with CVI		Time surgery and 24,48 and 72 h postoperative	Yes