EUCTR2015-002645-54-BE
Active, not recruiting
Phase 1
Comparison of efficacy between dexmedetomidine (DEX) and nicardipine (NIC) in adult facial surgery
niversitair Ziekenhuis Brussel0 sites40 target enrollmentSeptember 10, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- - maxillofacial surgery- pain relief requirement- surgical vision- hemodynamic stability- propofol remifentanil use
- Sponsor
- niversitair Ziekenhuis Brussel
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Adults: 18 years or older.
- •\- ASA I or II.
- •\- The subject has to undergo a maxillofacial surgery of more than 1 hour.
- •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 40
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •\-Use of anticoagulant drugs / anti\-platelet drugs
- •\-Hepatic dysfunction
- •\-Poorly controlled hypertension / hypotension
- •\-Active coronary artery disease
- •\-\<18 years or \>65 years
- •\-Advanced AV\-block (2nd or 3th degree), unless paced
- •\-Basal heart frequency less than 50 bpm
- •\-Pregnancy / Breastfeeding
- •\-No informed consent
- •\-Psychological disorders
Outcomes
Primary Outcomes
Not specified
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