Comparison in efficacy between dexmedetomidine (DEX) and nicardipine (NIC) in adult facial surgery

Phase 1

Conditions: - maxillofacial surgery- pain relief requirement- surgical vision- hemodynamic stability- propofol remifentanil use
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-002645-54-BE

Lead Sponsor: niversitair Ziekenhuis Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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

-Smoking
-Asthma
-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
-Soya allergy
-PONV antecedents
-Gastric duodenal impairment
-DM
-pheochromocytoma

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The goal of this study is to determine the effects of a continuous infusion on: surgical vision quality on the operation field;Secondary Objective: The goal of this study is to determine the effects of a continuous infusion on: postoperative pain relief;Primary end point(s): Visibility of the surgical field;Timepoint(s) of evaluation of this end point: the surgeon will evaluate the quality of visibilty during the operation,the score will be taken place after the operation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The need for pain relief after the operation;Timepoint(s) of evaluation of this end point: Evaluation every 4 hours with a VAS-score (pain scale) in the postoperative room (PACU) and until 24 hours later .