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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02580188
The Effect of Deep Neuromuscular Block on Surgical Condition During Laparoscopic Colorectal Surgery (DEEPCOL)
12 de março de 2019 atualizado por: BON WOOK KOO, Seoul National University Bundang Hospital
This study is a randomized, controlled, double-blinded, and parallel design study.
A total 96 patients were randomized to receive a deep block or a moderate block scheduled for elective laparoscopic colorectal surgery.
Investigators estimated the proportion of intra-abdominal pressure(IAP) alarm and surgical rating score.
Visão geral do estudo
Descrição detalhada
Patients >18 years of age with an america society of anesthesiologist classification of I or II who were scheduled to undergo elective laparoscopic colorectal surgery were included.
The exclusion criteria were a history of neuromuscular, renal, or hepatic disease, a history of low abdominal surgery; treatment with drugs known to interfere with neuromuscular function.
Patients were randomised to either the moderate or deep neuromuscular blockade group using Random Allocation Software (version 1.0).
Premedication with intravenous midazolam at 0.03 mg/kg was performed in the reception area.
In the operating room, routine monitoring was performed, including electrocardiography, non-invasive arterial pressure measurements, and pulse oximetry.
Additionally, acceleromyography was applied to monitor the response of the corrugator supercilii muscle.
Neuromuscular management and monitoring were performed according to the Good Clinical Research Practice guidelines.
After the induction of anaesthesia with propofol and remifentanil using target-controlled infusers and before rocuronium administration, the TOF-Watch-SX was calibrated and stabilised; a 50-Hz tetanic stimulation was applied for 5 s, the TOF-Watch-SX was calibrated, and a series of train-of-four (TOF) measurements were documented for >2 min until a stable baseline was obtained (<5% variation in the TOF ratios).
Next, intravenous rocuronium at 0.6 mg/kg was administered, and tracheal intubation was performed after confirmation of relaxation.
Anesthesia was maintained with desflurane and target-controlled infusion of remifentanil while monitoring the bispectral index.
A continuous dose of intravenous rocuronium (10-60 mg/hr) was used to maintain moderate (TOF count of 1 or 2) or deep (post-tetanic count [PTC] of 1 or 2) neuromuscular blockade.
The IAP alarm(IAP>15mmHg) rate were checked.
Any movement during the operation as reported by the surgeon or anaesthesiologist was recorded.
At the end of the operation, the surgeon rated the surgical condition on a 5-point scale.
Patients in the moderate group were reversed with neostigmine at 50 µg/kg and glycopyrrolate at 10 µg/kg at a TOF count of 1 or 2, and patients in the deep group were reversed with intravenous sugammadex at 4 mg/kg at PTC of 1 or 2. The time from administration of the reversal agents to a TOF ratio of 0.9 was recorded.
Postoperative pain and opioid consumption were evaluated at 24, 48h postoperatively.
Postoperative nausea and/or vomiting, dry mouth, were also evaluated at the same time points.
Tipo de estudo
Intervencional
Inscrição (Real)
70
Estágio
- Fase 4
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- American Society of Anesthesiologists grade 1 or 2
- Scheduled for elective laparoscopic Colorectal surgery
Exclusion Criteria:
- Severe respiratory or cardiac disease
- Severe hepatic or renal function impairment
- On medications affecting neuromuscular function
- Known allergy to the drugs to be used
- Pregnant
- Malignant hyperthernia
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Moderate block
Maintenance dose of 0.15-0.3
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of train of four count 1-2 (moderate block).
At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block.
|
|
|
Experimental: Deep block
Maintenance dose of 0.4-0.9
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
|
Maintenance dose of 0.4-0.9
mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg
Prazo: intraoperative, an averrage of 3 hour
|
Intra-abdominal pressure was maintained at 12 mmHg during pneumoperitoneum(using the carbon dioxide gas insufflation) and the pressure alarm for IAP was set at < 15 mmHg. Intra-abdominal pressure is measured in a separate machine connected to a carbon dioxide gas injection line. |
intraoperative, an averrage of 3 hour
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
Prazo: 24hr after end of operation
|
Postoperative pain is controlled by IV patient controlled analgesia using fentanyl.
If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.
|
24hr after end of operation
|
|
Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)
Prazo: 48hr after end of operation
|
Postoperative pain is controlled by IV patient controlled analgesia using fentanyl.
If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.
|
48hr after end of operation
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Ah-Young Oh, MD.,Ph.D., Seoul National Univ. Bundang Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
24 de março de 2015
Conclusão Primária (Real)
16 de junho de 2016
Conclusão do estudo (Real)
18 de junho de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
30 de setembro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de outubro de 2015
Primeira postagem (Estimativa)
20 de outubro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de março de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de março de 2019
Última verificação
1 de março de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- DNMBC-SNUBH
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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