Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery

Completed

• Conditions: Carotid Surgery
• Interventions: Procedure: MED-SEP; Procedure: TRI-SEP; Procedure: neuropsychological tests

• Registration Number: NCT00484796
• Lead Sponsor: Klinikum St. Georg gGmbH

Brief Summary

Hypothesis: Trigeminus-evoked somatosensory potentials (TRI-SEP) may be used as an alternative technique to medianus-evoked somatosensory potentials (MED-SEP) in patients undergoing elective carotid surgery.

Detailed Description

For CNS-monitoring somatosensory-evoked responses ba electrical stimulation of the contralateral median nerve are established: A reduction of amplitude and a delay in latency may represent a sensible marker of imminent cerebral ischemia. This study will evaluate a new concept by using trigeminal nerve evoked somatosensory evoked potentials in comparison to the established MED-SEP. Beside the comparison of two methods of neuromonitoring, this study will investigate the neurological long-term outcome (90-day evaluation) with different neuropsychological tests for the detection of cognitive deficits.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-06-08
• Study First Submitted QC: 2007-06-08
• Study First Posted: 2007-06-11
• Primary Completion: 2011-06
• Study Completion: 2012-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-26
• Last Update Posted: 2012-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age >= 18 years
• Agreement with study procedure
• Elective carotid surgery

Exclusion Criteria

• Inability to take somatosensory potentials
• Inability to respond to neuropsychological tests
• Severe preoperative neurological deficit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	MED-SEP	Patients undergoing carotid surgery
1	TRI-SEP	Patients undergoing carotid surgery
1	neuropsychological tests	Patients undergoing carotid surgery

Primary Outcome Measures

Name	Time	Method
detection of episodes of cerebral ischemia during carotid surgery	intraoperative, 28 days, and 60 days after surgery

Trial Locations

Locations (1)

Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy; 🇩🇪 Leipzig, Sachsen, Germany