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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002645-54-BE

Enrollment

Registered

2015-09-10

Start date

2015-12-23

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Rydene Product Name: nicardipine Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: nicardipine CAS Number: 54527-84-3 Other descriptive name: NICARDIPINE HYDROCHLOR

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: - Smoking - Asthma - Use of anticoagulant drugs / anti-platelet drugs - Hepatic dysfunction - Poorly controlled hypertension / hypotension - Active coronary artery disease - 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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 .	—

Countries

Belgium

Contacts

Public ContactData Nurse

Universitair Ziekenhuis Brussel

veerle.vanmossevelde@uzbrussel.be+3224763134

Outcome results