RBR-88hg3bh Acupuncture on the control of nausea and vomiting in patients undergoing Bariatric Surgery in a private hospital in São...

Date of registration: 10/03/2025 ^(mm/dd/yyyy)
Last approval date : 10/03/2025 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1324-5368

• Public title:

  en

  Acupuncture on the control of nausea and vomiting in patients undergoing Bariatric Surgery in a private hospital in São Luís-Ma

  pt-br

  Acupuntura no controle de náuseas e vômitos em pacientes submetidos à Cirurgia Bariátrica em um hospital particular de São Luís-Ma

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 82824724.2.0000.5085
    Issuing authority: Plataforma Brasil
  • 7.109.631
    Issuing authority: Comitê de Ética em Pesquisa do Hospital São Domingos

Sponsors

• Primary sponsor: Hospital São Domingos
• Secondary sponsor:
  • Institution: Hospital São Domingos
• Supporting source:
  • Institution: Universidade Federal do Maranhão

Health conditions

• Health conditions:

  en

  Postoperative Nausea and Vomiting

  pt-br

  Náusea e Vômito Pós-Operatórios

• General descriptors for health conditions:

  en

  C18.654.726.750.500 Obesity

  pt-br

  C18.654.726.750.500 Obesidade

• Specific descriptors:

  en

  C23.550.767.859 Postoperative Nausea and Vomiting

  pt-br

  C23.550.767.859 Náusea e Vômito Pós-Operatórios

Interventions

• Interventions:

  en

  This is a randomized, three-arm, double-blind clinical trial. Group C: 34 obese patients will receive treatment with antiemetics. Group Z: 34 obese patients will receive treatment with antiemetics associated with acupoint Zusanli (ST36). Group I: 34 obese patients will receive treatment with antiemetics associated with acupoints Zusanli (ST36), LI4 (Hegu), PC6 (Neiguan) and Danzhong (CV17)

  pt-br

  Trata-se de um um ensaio clínico, randomizado, com três braços e duplo cego. Grupo C: 34 pacientes com obesidade receberão tratamento com antieméticos. Grupo Z: 34 pacientes com obesidade receberão tratamento com antieméticos associados com acuponto Zusanli (ST36). Grupo I: 34 pacientes com obesidade receberão tratamento com antieméticos associado com os acupontos Zusanli (ST36), LI4 (Hegu), PC6 (Neiguan) e Danzhong (CV17)

• Descriptors:

  en

  H02.004 Acupuncture

  pt-br

  H02.004 Acupuntura

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 12/01/2025 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  102	-	18 Y	0

• Inclusion criteria:

  en

  Patients undergoing bariatric surgery; aged 18 or over; with assessment of postoperative nausea and vomiting will be included in the study

  pt-br

  Pacientes submetido à cirurgia bariátrica; com 18 anos ou mais; com avaliação de náuseas e vômitos pós-operatórios

• Exclusion criteria:

  en

  Those who do not consent to participate in the research; contraindications to acupuncture techniques such as rash at the point of stimulation on the skin or systemic infection; severe obstructive sleep apnea syndrome; uncontrolled systemic diseases of the heart, lung, kidney or liver; coagulation disorders

  pt-br

  Aqueles que não consentirem em participar da pesquisa; contraindicação das técnicas de acupuntura, como erupção cutânea no ponto de estimulação na pele; infecção sistêmica síndrome de apneia obstrutiva do sono grave; doenças sistêmicas do coração, pulmão, rim ou fígado não controlados; distúrbios de coagulação

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Prevention	Parallel	3	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  It is expected to observe a lower occurrence of postoperative nausea and vomiting in patients undergoing bariatric surgery with acupuncture points

  pt-br

  Espera-se observar menor ocorrência de náuseas e vômitos pós-operatório de pacientes submetidos a cirurgia bariátrica com pontos de acupuntura

• Secondary outcomes:

  en

  It is expected to observe better quality of the postoperative period, assessed by the Quality of Recovery-15 (QoR-15) questionnaire, in the groups with acupuncture points

  pt-br

  Espera-se observar melhor qualidade do pós-operatório, avaliada pelo questionário Quality of Recovery-15 (QoR-15), nos grupos com pontos de acupuntura

Contacts

• Public contact
  • Full name: Sérgio Sousa Sena Santos
  • • Address: Av. dos Portugueses, 1966 - Vila Bacanga
    • City: São Luís / Brazil
    • Zip code: 65080-805
  • Phone: +5598981741711
  • Email: sergiouema@gmail.com
  • Affiliation: Hospital São Domingos
   
• Scientific contact
  • Full name: Sérgio Sousa Sena Santos
  • • Address: Av. dos Portugueses, 1966 - Vila Bacanga
    • City: São Luís / Brazil
    • Zip code: 65080-805
  • Phone: +5598981741711
  • Email: sergiouema@gmail.com
  • Affiliation: Hospital São Domingos
   
• Site contact
  • Full name: Sérgio Sousa Sena Santos
  • • Address: Av. dos Portugueses, 1966 - Vila Bacanga
    • City: São Luís / Brazil
    • Zip code: 65080-805
  • Phone: +5598981741711
  • Email: sergiouema@gmail.com
  • Affiliation: Hospital São Domingos
   

Additional links:

• Download in ICTRP format