Effect of dexmedetomidine on monitoring of central nervous system during brain surgery

• Conditions: Patients scheduled for supratentorial craniotomy or brainstem surgery with intraoperative monitoring of motor evoked potentials (MEP).; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-000962-23-ES
• Lead Sponsor: Consorci Parc de Salut Mar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-09
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1- Male and females over 18 years.
2- Patients undergoing supratentorial craniotomy or brainstem surgery due to tumors located in these areas.
3- Patients who have given the informed written consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients with hypovolemic shock or atrioventricular block
Patients with liver disease ( altered transaminases)
Motor and sensory deficit prior preoperative anaesthetic evaluation
Moderate- severe renal insufficiency( creatinine clearance< 60 ml/min)
Allergy or hypersensitivity to drugs or excipients used in the study
Pregnancy
Patients who have entered in other study, three months before surgery

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified