Public trial
RBR-2qfz6q The role of anesthetics in breast surgery
Date of registration: 06/10/2019 (mm/dd/yyyy)Last approval date : 06/10/2019 (mm/dd/yyyy)
Study type:
Observational
Scientific title:
en
Total venous anaesthesia versus balanced anaesthesia in breast surgery
pt-br
Anestesia venosa versus anestesia balanceada em cirurgia de mama
Trial identification
- UTN code: U1111-1228-1152
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Public title:
en
The role of anesthetics in breast surgery
pt-br
O papel dos anestésicos em cirurgia de mama
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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CAAE 07510919.1.0000.5461
Issuing authority: Plataforma Brasil
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Parecer 3.152.383
Issuing authority: Comite de Etica do Hospital Sirio Libanes
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CAAE 07510919.1.0000.5461
Sponsors
- Primary sponsor: Hospital Sírio-Libanês
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Secondary sponsor:
- Institution: Hospital Sírio-Libanês
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Supporting source:
- Institution: Hospital Sírio-Libanês
Health conditions
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Health conditions:
en
Malignant neoplasm of breast
pt-br
Neoplasia maligna de mama
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General descriptors for health conditions:
en
C00-D48 II - Neoplasms
pt-br
C00-D48 II - Neoplasias [tumores]
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Specific descriptors:
Interventions
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Interventions:
en
IT will be included data from 200 patients with breast cancer who underwent surgical indication of radical mastectomy performed with total venous anesthesia or balanced anesthesia.
pt-br
Serão incluídos dados de prontuário de 200 pacientes com câncer de mama que foram submetidos a mastectomia radical e que durante a cirurgia receberam anestesia venosa total ou anestesia balanceada.
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Descriptors:
en
D05.9 Carcinoma in situ of breast, unspecified
pt-br
D05.9 Carcinoma in situ da mama, não especificado
es
D05.9 Carcinoma in situ de la mama, parte no especificada
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 03/01/2019 (mm/dd/yyyy)
- Date last enrollment: 06/19/2019 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 200 F 18 Y 75 Y -
Inclusion criteria:
en
Female patients between the ages of 18 and 75 undergoing radical mastectomy.
pt-br
Pacientes do sexo feminino entre 18 e 75 anos submetidas à mastectomia radical.
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Exclusion criteria:
en
Patients with previous diagnosis of psychiatric disease Missing analogue visual scale (EVA) data, tool used for pain assessment Patient with pain before the surgical procedure. Patient who used the Patient Controlled Analgesia Pump (PCA) after surgery. Patient who underwent anesthetic block during the surgical procedure.
pt-br
Pacientes com diagnóstico prévio de doença psiquiátrica Faltando dados da escala visual analógico (EVA), ferramenta utilizada para avaliação da dor Paciente com dor previamente ao procedimento cirúrgico. Paciente que utilizou Bomba de Analgesia Controlada pelo Paciente (PCA) pós cirurgia. Paciente que realizou bloqueio anestésico durante o procedimento cirúrgico.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Prognostic Parallel 2 Open Non-randomized-controlled N/A
Outcomes
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Primary outcomes:
en
Evaluate the efficacy of total venous anesthesia compared to the balanced one in breast surgery considering postoperative pain.
pt-br
Avaliar a eficácia da anestesia venosa total em comparação com a balanceada em cirurgia de mama considerando-se a dor pós-operatória.
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Secondary outcomes:
en
Evaluate the use of analgesics in the postoperative period.
pt-br
Avaliar o uso de analgésicos no pós-operatório.
en
To evaluate the patients' time of hospitalization after the surgical procedure.
pt-br
Avaliar o tempo de internação dos pacientes após a realização do procedimento cirúrgico.
en
Side effects evaluation (such as nausea, vomiting, pruritus, sedation, dizziness, abdominal distension and sweating) and adverse events (such as hypoventilation, hypotension and respiratory depression) in the postoperative period.
pt-br
Efeitos colaterais (como por exemplo náuseas, vômito, prurido, sedação, tontura, distensão abdominal e sudorese) e eventos adversos (como hipoventilação, hipotensão e depressão respiratória) no pós-cirúrgico.
Contacts
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Public contact
- Full name: Marcio Matsumoto
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- Address: Rua Prof Daher Cutait, 69
- City: Sao Paulo / Brazil
- Zip code: 01308-060
- Phone: +55(11)33944779
- Email: marciomatsumoto46@hotmail.com
- Affiliation: Hospital Sírio-Libanês
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Scientific contact
- Full name: Marcio Matsumoto
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- Address: Rua Prof Daher Cutait, 69
- City: Sao Paulo / Brazil
- Zip code: 01308-060
- Phone: +55(11)33944779
- Email: marciomatsumoto46@hotmail.com
- Affiliation: Hospital Sírio-Libanês
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Site contact
- Full name: Marcio Matsumoto
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- Address: Rua Prof Daher Cutait, 69
- City: Sao Paulo / Brazil
- Zip code: 01308-060
- Phone: +55(11)33944779
- Email: marciomatsumoto46@hotmail.com
- Affiliation: Hospital Sírio-Libanês
Additional links:
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