RBR-6s3kkr Blood pressure control with metoprolol or clonidine medications in ear, nose or throat surgeries in patients with high…

Date of registration: 04/24/2019 ^(mm/dd/yyyy)
Last approval date : 04/24/2019 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1211-7890

• Public title:

  en

  Blood pressure control with metoprolol or clonidine medications in ear, nose or throat surgeries in patients with high blood pressure

  pt-br

  Controle da pressão sanguínea com as medicações metoprolol ou clonidina em cirurgias de ouvido, nariz ou garganta em pacientes com pressão alta

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 79705417.4.0000.5208
    Issuing authority: Plataforma Brasil
  • Parecer número 2.514.730
    Issuing authority: Cômite de Ètica em Pesquisa do Centro de Ciências da Saúde da UFPE

Sponsors

• Primary sponsor: Hospital das Clínicas
• Secondary sponsor:
  • Institution: Hospital das Clínicas
• Supporting source:
  • Institution: Hospital das Clínicas

Health conditions

• Health conditions:

  en

  Hypertension

  pt-br

  Hipertensao essencial (primaria)

• General descriptors for health conditions:

  en

  C23 Pathological conditions, signs and symptoms

  pt-br

  C23 Condições patológicas, sinais e sintomas

  es

  C23 Condiciones patológicas, signos y síntomas

• Specific descriptors:

Interventions

• Interventions:

  en

  Control group, clonidine will be made 150 mcg, IV (intravenous), with 31 patients. Intervention group will be made metoprolol 10 mg, IV, with 31 patients. In either group, either clonidine, or metoprolol, will be administered once, 20 minutes before surgery. Patients will be followed up during surgery and after surgery for up to 6 hours

  pt-br

  Grupo controle, será feito clonidina 150 mcg, IV (intra-venoso), com 31 pacientes. Grupo intervenção, será feito metoprolol 10 mg, IV, com 31 pacientes. Em cada grupo, será administrado ou clonidina, ou metoprolol, uma vez, 20 minutos antes da cirurgia. Os pacientes serão acompanhados durante a cirurgia e após a cirurgia por até 6 horas.

• Descriptors:

  en

  D03.383.129.308.436.500 Clonidine

  pt-br

  D03.383.129.308.436.500 Clonidina

  es

  D03.383.129.308.436.500 Clonidina

  en

  D02.033.100.624.698.573 Metoprolol

  pt-br

  D02.033.100.624.698.573 Metoprolol

  es

  D02.033.100.624.698.573 Metoprolol

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 10/10/2018 ^(mm/dd/yyyy)
• Date last enrollment: 05/01/2020 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  62	-	18 Y	65 Y

• Inclusion criteria:

  en

  Patients older than 18 years and up to 65 years old, hypertensive, who arrive at the surgical center to perform otorhinolaryngological surgeries

  pt-br

  Pacientes maiores de 18 anos e com até 65 anos de idade, hipertensos, que chegam ao centro cirúrgico para realizar cirurgias otorrinolaringológicas

• Exclusion criteria:

  en

  Patients with a heart rate of less than 60 beats per minute, patients with contraindication or allergy to clonidine or metoprolol, patients weighing less than 50 kg or patients weighing more than 100 kg, patients using a pacemaker

  pt-br

  Pacientes com frequencia cardíaca menor que 60 batimentos por minuto, pacientes com contra-indicação ou alergia ao uso de clonidina ou metoprolol, pacientes pesando menos de 50 kg ou pacientes pesando mais de 100 kg, pacientes em uso de marcapasso

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Double-blind	Randomized-controlled	4

Outcomes

• Primary outcomes:

  en

  Systolic blood pressure lower than 140 mmHg and diastolic blood pressure lower than 90 mmHg after the end of anesthesia. We will determine the percentage of patients who reach hypertensive patients at the surgical center, and at the end of surgery, they have normal blood pressure values

  pt-br

  Pressão arterial sistólica menor que 140 mmHg e pressão arterial diastólica menor que 90 mmHg após término da anestesia. Determinaremos o percentual de pacientes que chegam hipertensos ao bloco cirúrgico, e ao final da cirurgia, encontram-se com valores normais de pressão arterial

• Secondary outcomes:

  en

  Systolic and diastolic blood pressure and heart rate measured every 15 minutes intraoperatively; postoperative heart rate, total dose of vasopressors, bleeding of the surgical field and postoperative bleeding, need for surgical reintervention after surgery, blood pressure measurement and heart rate four hours after discharge from the post-anesthetic recovery room between patients receiving clonidine and Metoprolol

  pt-br

  Pressão arterial sistólica e diastólica, e frequência cardíaca medidos a cada 15 minutos no intraoperatório; frequência cardíaca pós-operatória, dose total do uso de vasopressores, sangramento do campo cirúrgico e sangramento pós-operatório, necessidade de reintervenção cirúrgica após a cirurgia, medida da pressão arterial e frequencia cardíaca quatro horas após a alta da sala de recuperação pós-anestésica entre pacientes medicados com clonidina e Metoprolol

Contacts

• Public contact
  • Full name: Sérgio Veloso da Silveira Menezes
  • • Address: Rua Real Da Torre, 955, apartamento 2901
    • City: Recife / Brazil
    • Zip code: 52050-030
  • Phone: +55-081-992161866
  • Email: sergiovdsm@gmail.com
  • Affiliation: Hospital das Clínicas
   
• Scientific contact
  • Full name: Sérgio Veloso da Silveira Menezes
  • • Address: Rua Real Da Torre, 955, apartamento 2901
    • City: Recife / Brazil
    • Zip code: 52050-030
  • Phone: +55-081-992161866
  • Email: sergiovdsm@gmail.com
  • Affiliation: Hospital das Clínicas
   
• Site contact
  • Full name: Sérgio Veloso da Silveira Menezes
  • • Address: Rua Real Da Torre, 955, apartamento 2901
    • City: Recife / Brazil
    • Zip code: 52050-030
  • Phone: +55-081-992161866
  • Email: sergiovdsm@gmail.com
  • Affiliation: Hospital das Clínicas
   

Additional links:

• Download in ICTRP format