RBR-6g2vcnx Evaluation of the effect of a neuromuscular blocker in patients undergoing gastric bypass surgery by videolaparoscopy

Date of registration: 05/21/2024 ^(mm/dd/yyyy)
Last approval date : 05/21/2024 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1275-4823

• Public title:

  en

  Evaluation of the effect of a neuromuscular blocker in patients undergoing gastric bypass surgery by videolaparoscopy

  pt-br

  Avaliação do efeito do bloqueador neuromuscular em pacientes submetidos a cirurgia de redução do estômago por videolaparoscopia

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 4.987.496
    Issuing authority: Comitê de Ética em Pesquisa do Hospital e Maternidade São Domingos
  • 51338721.8.0000.5085
    Issuing authority: Plataforma Brasil

Sponsors

• Primary sponsor: Hospital São Domingos
• Secondary sponsor:
  • Institution: Hospital São Domingos
• Supporting source:
  • Institution: Hospital São Domingos

Health conditions

• Health conditions:

  en

  Obesity; Postoperative Pain; Gastric Bypass

  pt-br

  Obesidade; Dor Pós-Operatória; Derivação Gástrica

• General descriptors for health conditions:

  en

  E02.650.500.062 Bariatric surgery

  pt-br

  E02.650.500.062 Cirurgia Bariátrica

• Specific descriptors:

  en

  C23.550.767.700 Pain Postoperative

  pt-br

  C23.550.767.700 Dor Pós-Operatória

  en

  C23.888.144.699.500 Obesity

  pt-br

  C23.888.144.699.500 Obesidade

  en

  E02.650.500.062.249 Gastric Bypass

  pt-br

  E02.650.500.062.249 Derivação Gástrica

Interventions

• Interventions:

  en

  All patients will receive intravenous general anesthesia with propofol 2 mg.kg-1, fentanyl 3 mcg.kg-1, dexmedetomidine 0.5 mcg.kg-1 and rocuronium (dose depending on randomization). Intraoperatively, the patient will receive propofol with an estimated BIS between 40-50. In case of > 15% increase in heart rate or mean arterial pressure compared to preoperative values, remifentanil (0.05-0.2 mcg.kg-1.min-1) will be administered. Monitoring will consist of electrocardiography, capnography, non-invasive blood pressure and heart rate. Management of postoperative pain will initially be based on preventive treatment with dipyrone 2g, ketoprofen 100 mg. Prophylaxis of nausea and vomiting will be with dexamethasone 10 mg at induction of anesthesia and ondansetron 8 mg at the end of surgery. Neuromuscular function will be monitored using acceleromyography. For this purpose, two electrodes will be placed on the ulnar nerve of the left or right wrist, and a flexible adapter will be placed on the ipsilateral thumb to generate preload and a sensor will be placed on its tip. Adduction of the thumb through contractions of the adductor pollicis brevis muscle will be detected by the thumb sensor. After induction of anesthesia, but prior to any administration of rocuronium, the device will be calibrated according to the manufacturer's specifications. In the study, we will measure the twitch response to four subsequent electrical stimuli (i.e. train-of-four “sequence of four stimuli” or TOF) at 10-minute intervals. If no thumb twitch is detected, the post-tetanic count (PTC) will be measured. Patients will be randomly assigned to two groups using Randomizer® software. Moderate (group 1) or profound (group 2) neuromuscular blockade (NMB), each group with a sample of 50 subjects. The numbers of patients and the groups they will belong to will be drawn. These numbers will be placed in envelopes, which will be drawn on the day of the surgery. The distribution of patients in groups will be done by lot before starting the study, and identified in sealed envelopes numbered from 1 to 100. On the day of surgery, an envelope will be drawn and opened immediately before anesthetic induction The study will have a double-blind design with the surgeons and research team completely blinded to the treatment. Only the responsible anesthesiologist will not be blinded and will be responsible for administering the correct NMB, according to the drawn group. The responsible anesthesiologist will receive the randomization code upon induction from an independent individual who will not be part of the research team. Patients will receive 0.6 mg.kg-1 intravenous rocuronium before intubation. By placing the camera in the abdominal cavity, the surgeon will assess the surgical quality of the cavity. Thereafter repeated intravenous doses of 10 mg of rocuronium will be administered to achieve a TOF count of 1-2 contractions (moderate NMB) or TOF with 0 contractions and 2-3 contractions in CTP (deep NMB). Such monitoring and repeated intravenous doses will be administered until surgery is completed. At the end of the surgery, moderate NMB will be reversed with sugammadex (2 mg/kg ideal body weight), while deep NMB will be reversed with sugammadex (4 mg/kg ideal body weight) . The endotracheal tube will be removed when the TOF ratio > 0.9 and the patient is fully awake and breathing spontaneously. After surgery, all patients will be monitored in the anesthetic recovery room and, subsequently, referred to the ward. All will have a PCA pump to control postoperative pain. Morphine, 0.5 mg, will be administered on demand, every 5 minutes, according to the patient's request.Patients will be randomly assigned to two groups using Randomizer® software. Moderate (group 1) or profound (group 2) neuromuscular blockade (NMB), each group with a sample of 50 subjects. The numbers of patients and the groups they will belong to will be drawn. These numbers will be placed in envelopes, which will be drawn on the day of the surgery. The distribution of patients in groups will be done by lot before starting the study, and identified in sealed envelopes numbered from 1 to 100. On the day of surgery, an envelope will be drawn and opened immediately before anesthetic induction The study will have a double-blind design with the surgeons and research team completely blinded to the treatment. Only the responsible anesthesiologist will not be blinded and will be responsible for administering the correct NMB, according to the drawn group. The responsible anesthesiologist will receive the randomization code upon induction from an independent individual who will not be part of the research team. Patients will receive 0.6 mg.kg-1 intravenous rocuronium before intubation. By placing the camera in the abdominal cavity, the surgeon will assess the surgical quality of the cavity. Thereafter repeated intravenous doses of 10 mg of rocuronium will be administered to achieve a TOF count of 1-2 contractions (moderate NMB) or TOF with 0 contractions and 2-3 contractions in CTP (deep NMB). Such monitoring and repeated intravenous doses will be administered until surgery is completed. At the end of the surgery, moderate NMB will be reversed with sugammadex (2 mg/kg ideal body weight), while deep NMB will be reversed with sugammadex (4 mg/kg ideal body weight) . The endotracheal tube will be removed when the TOF ratio > 0.9 and the patient is fully awake and breathing spontaneously. After surgery, all patients will be monitored in the anesthetic recovery room and, subsequently, referred to the ward. All will have a patient-controlled analgesia pump (PCA) to control postoperative pain. Morphine, 0.5 mg, will be administered on demand, every 5 minutes, according to the patient's request.

  pt-br

  Todos os pacientes receberão anestesia geral intravenosa com propofol 2 mg.kg-1, fentanil 3 mcg.kg-1, dexmedetomidina 0,5 mcg.Kg-1 e rocurônio (dose a depender da randomização). No intra-operatório, paciente receberá propofol com um BIS estimado entre 40-50. Em caso de aumento de > 15% da frequência cardíaca ou da pressão arterial média em relação aos valores pré-operatórios, será administrado remifentanil (0,05-0,2 mcg.kg-1.min-1). A monitorização será constituída pela eletrocardiografia, capnografia, pressão arterial não invasiva e frequência cardíaca. O manuseio da dor pós-operatória será inicialmente baseado no tratamento preventivo com dipirona 2g, cetoprofeno 100 mg. A profilaxia de náuseas e vômitos será com dexametasona 10 mg na indução da anestesia e ondansetrona 8 mg no final da cirurgia. A função neuromuscular será monitorada usando aceleromiografia. Para tanto, serão colocados dois eletrodos sobre o nervo ulnar do punho esquerdo ou direito, e no polegar ipsilateral serão colocados adaptador flexível para gerar a pré-carga e um sensor será colocado em sua ponta. A adução do polegar por meio de contrações do músculo adutor curto do polegar será detectada pelo sensor do polegar. Após a indução da anestesia, mas antes de qualquer administração de rocurônio, o dispositivo será calibrado de acordo com as especificações do fabricante. No estudo, mediremos a resposta de contração por quatro estímulos elétricos subsequentes (i.e. train-of-four “sequência de quatro estímulos” ou TOF) em intervalos de 10 minutos. Se nenhuma contração do polegar for detectada, a contagem pós-tetânica (CTP) será medida. Os pacientes serão designados aleatoriamente para dois grupos usando o software Randomizer®. Bloqueio neuromuscular (BNM) moderado (grupo 1) ou BNM profundo (grupo 2), cada grupo com uma amostra de 50 indivíduos. Serão sorteados os números dos pacientes e os grupos a que pertencerão. Esses números serão colocados em envelopes, que serão sorteados no dia da cirurgia. A distribuição dos pacientes nos grupos será feita por sorteio antes de ser iniciado o estudo, e identificados em envelopes lacrados numerados de 1 a 100. No dia da cirurgia, um envelope será sorteado e aberto imediatamente antes da indução anestésica O estudo terá um desenho duplo-cego com os cirurgiões e a equipe de pesquisa totalmente cegos para o tratamento. Apenas o anestesiologista responsável não será cego e será o responsável pela administração do BNM correto, conforme o grupo sorteado. O anestesiologista responsável receberá o código de randomização na indução de um indivíduo independente que não fará parte da equipe de pesquisa. Os pacientes receberão 0,6 mg.kg-1 de rocurônio intravenoso antes da intubação. Ao colocar a câmera na cavidade abdominal, o cirurgião avaliará a qualidade cirúrgica da cavidade. A partir daí doses intravenosas repetidas de 10 mg de rocurônio serão administradas para atingir uma contagem de TOF de 1-2 contrações (BNM moderado) ou TOF com 0 contrações e 2-3 contrações na CTP (BNM profundo). Essa monitorização e doses intravenosas repetidas serão administradas até o término da cirurgia. No final da cirurgia, o BNM moderado será revertido com sugamadex (2 mg/kg de peso corporal ideal), enquanto o BNM profundo será revertido com sugamadex (4 mg/kg de peso corporal ideal) . O tubo endotraqueal será removido quando a razão TOF > 0,9 e o paciente estiver totalmente acordado e respirando espontaneamente. Após a cirurgia, todos os pacientes serão monitorizados na sala de recuperação anestésica e, posteriormente, encaminhados para a enfermaria. Todos ficarão com bomba de analgesia controlada pelo paciente (PCA) para controle da dor pós-operatória. Será administrada morfina, 0,5 mg, sob demanda, a cada 5 minutos, de acordo com a solicitação do paciente.

• Descriptors:

  en

  D27.505.696.663.700.710 Neuromuscular Blockers

  pt-br

  D27.505.696.663.700.710 Bloqueadores Neuromusculares

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 10/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  100	-	18 Y	65 Y

• Inclusion criteria:

  en

  aged between 18 and 65 years, both sexes, with an ASA score from 1 to 3, undergoing roux-en-y gastric bypass by robotic surgery will be included in the study.

  pt-br

  idade entre 18 e 65 anos, ambos os sexos, com pontuação ASA de 1 a 3, submetidos a bypass gástrico em y de roux por cirurgia bobótica.

• Exclusion criteria:

  en

  Patients with cardiac arrhythmias, dilated cardiomyopathy, cardiac conduction disorder, electrolyte disturbance, acid base disturbance, known or suspected allergies to drugs used during anesthesia, family history of neuromuscular disease, family history of malignant hyperthermia, and renal failure, psychiatric, hepatic, respiratory or oncological diseases, who are receiving any type of analgesic in the week before surgery and those who receive blood products during the study period.

  pt-br

  Pacientes que apresentarem arritmias cardíacas, miocardiopatia dilatada, distúrbio de condução cardíaca, distúrbio eletrolítico, distúrbio ácido básico, alergias conhecidas ou suspeitas a medicamentos usados durante a anestesia, história familiar de doença neuromuscular, história familiar de hipertermia maligna e insuficiência renal, doenças psiquiátricas, hepáticas, respiratórias ou oncológicas, que estiverem recebendo qualquer tipo de analgésico na semana anterior à cirurgia e aqueles que receberem hemoderivados durante o período do estudo.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Prevention	Parallel	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Patients in the sustained deep neuromuscular blockade group are expected to obtain better surgical conditions with reduced postoperative pain and consequently lower postoperative pain scores. Assessment will be performed using questionnaires at defined times to check pain intensity, time of first request for opioid use and total opioid consumption in the first 24 hours.

  pt-br

  Espera-se que os pacientes do grupo do bloqueio neuromuscular profundo sustentado obtenha melhores condições cirúrgicas com redução da dor pós-operatória consequentemente com escores de dor pós-operatória menor. Será realizada a avaliação por meio de questionários em horários definidos para verificação da intensidade da dor, tempo da primeira solicitação para uso de opióide e o consumo total de opióide nas primeiras 24 horas.

• Secondary outcomes:

  en

  No secondary results expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: Hiago Parreão Braga Parreão Braga
  • • Address: Avenida Jerônimo de Albuquerque, 540
    • City: São Luis / Brazil
    • Zip code: 65060-645
  • Phone: +559832168100
  • Email: hiago_braga@hotmail.com
  • Affiliation: Hospital São Domingos
   
• Scientific contact
  • Full name: Hiago Parreão Braga Parreão Braga
  • • Address: Avenida Jerônimo de Albuquerque, 540
    • City: São Luis / Brazil
    • Zip code: 65060-645
  • Phone: +559832168100
  • Email: hiago_braga@hotmail.com
  • Affiliation: Hospital São Domingos
   
• Site contact
  • Full name: Hiago Parreão Braga Parreão Braga
  • • Address: Avenida Jerônimo de Albuquerque, 540
    • City: São Luis / Brazil
    • Zip code: 65060-645
  • Phone: +559832168100
  • Email: hiago_braga@hotmail.com
  • Affiliation: Hospital São Domingos
   

Additional links:

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