Bilateral Bispectral Index (BIS)-Monitoring in Trauma Surgery

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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Key information

Conditions

Knee Replacement Surgery

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antoni Sabate Pes

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Oct 4, 2010
Registry last updated: Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed