- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06867302
Dexmedetomidina e agitação após cirurgia nasal
Eficácia do bolus único versus infusão contínua de dexmedetomidina na mitigação da agitação em adultos submetidos a cirurgia nasal: um estudo prospectivo randomizado
The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery.
Visão geral do estudo
Status
Condições
Descrição detalhada
Agitation during emergence from general anesthesia is a potentially serious phenomenon that has not been studied in adults as often as in pediatric population. When agitation, serious self-injury, or violence towards the medical team occur, with the risk of aspiration, bleeding, hypoxia, arrhythmias, or simply pulling the endotracheal tubes, removal of drains or catheters. Moreover, agitated patients are not only at risk of developing complications but also, they are labor intensive as they require more medical attention, rescue drugs, and more attending staff till agitation attack safely subside. Recognized risk factors to develop emergence agitation (EA) in adults include ear, nose, and throat surgery, obesity, sevoflurane anesthesia, endotracheal tube, and history of psychological illness. In adults, adjuvants have been co-administered with general anesthesia in order to negate or reduce the incidence of EA especially in patients with identified risk factors.
dexmedetomidine is a highly selective α2 sympatholytic, has been proposed as an attractive candidate for the prophylaxis of EA. By interacting with α2 receptors in locus coeruleus of the pons, Dex exerts its unique anxiolytic, sedative and sympathetic antagonistic action with no respiratory depression. Moreover, it has pain-modulating effect due to interaction with α2 receptor sites in the dorsal horn and supra-spinal regions.
Nevertheless, there have been conflicting data about Dex optimal dose and time of administration when used as prophylaxis against EA. Indeed, different dosing protocols are associated with over sedation, prolonged extubation time, and delayed post-anaesthesia care unit time.
No premedication. Basic general anesthesia monitoring included electrocardiogram, pulse oximetry, non-invasive arterial pressure, and capnography, were recorded every 5 min. Preoxygenation with 100% oxygen for 5 min was performed before fentanyl 1 μg/kg and propofol 1.5-2 mg/ kg, were administered as induction agents. Intubation with facilitated with atracurium besylate 0.5 mg/ kg. The size of endotracheal tubes was 6.5-7.5 mm, for females and males, respectively. Mechanical ventilation was set on 6 ml/kg tidal volume, and respiratory rate was adjusted to keep end-tidal CO2 between 35 and 40 mmHg, in 50% O2/air. All patients at induction were given dexamethasone 4 mg i.v., ondansetron, 4 mg i.v to prevent post-operative nausea and vomiting, plus Ringers lactate solution 6 mg/ kg drip for basic volume maintenance. Blood loss was compensated for with Ringers lactate, intraoperatively. Maintenance of anesthesia was carried out with Isoflurane, regulated at 2-3%, Titrated incremental doses of atropine 0.5 mg, esmolol 10 mg, and ephedrine 6 mg were given i.v., when HR ≤ 45, HR ≥ 120 and MAP ≤ 60, in the mentioned order. ketorolac 30 mg was given I.M., at the time of nasal packing.
When surgery was finished, gentle suction was attempted, non-depolarizing muscle relaxant reverse with atropine, 0.5 mg and neostigmine 0.02 mg/kg was given. Next, isoflurane was turned off and respiration was then converted back to manual ventilation with 100% oxygen at 7 L/min. The patients were not disturbed, except by continual verbal requests to open their eyes. All other stimuli were prevented. Extubation was done when patients were able to breathe spontaneously and interact with verbal demands. When patients were awake, calm, and sedated, they were transferred to the PACU. Patients were discharged from the PACU when their Aldrete score was ≥ 9.
Statistical analysis:
Statistical analysis will be conducted using IBM SPSS Statistics 22 (IBM Corporation, USA). The normal distribution of data will be assessed by the Kolmogorov-Smirnov and Shapiro-Wilk tests. Mean and standard deviation will be used as descriptive statistics for normally distributed numerical variables, while median and interquartile range (25th to 75th percentiles) will be used as descriptive statistics for non-normally distributed numerical variables. In addition, Chi-square test or fisher exact test will be employed to test the significance between categorical variables as appropriate. Independent t test will be employed for numerical data that exhibited normal distribution, whereas the Mann-Whitney test will be used for numerical data that did not adhere to normal distribution. A significance level of p < 0.05 will be deemed to be statistically significant.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yasser S Mostafa, MD
- Número de telefone: +2 01010509735
- E-mail: ysm03@fayoum.edu.eg
Estude backup de contato
- Nome: Mohamed A Shawky, MD
- Número de telefone: +2 0 109 525 4547
- E-mail: mas14@fayoum.edu.eg
Locais de estudo
-
-
Faiyum Governorate
-
Al Fayyum, Faiyum Governorate, Egito, 63514
- Recrutamento
- Fayoum University Hospital
-
Contato:
- Yasser S Mostafa, MD.
- Número de telefone: +2 01010509735
- E-mail: ysm03@fayoum.edu.eg
-
Contato:
- Mohamed A Shawky, MD
- Número de telefone: +2 01095254547
- E-mail: mas14@fayoum.edu.eg
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- American Society of Anesthesiologist (ASA) Ⅰ or II
- Adults with body mass index (BMI) < 30 Kg/m
- Underwent elective nasal surgery.
Exclusion Criteria:
- Significant comorbidity like hepatic, renal, or cardiac disease
- Auditory impairment
- Cognitive dysfunction
- Substance abuse
- Allergy to the studied medicines
- Planned intensive care admission after the surgery.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Bolus group
single dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery |
Medicamento: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)
An infusion given all through intraoperative time
Outros nomes:
|
|
Experimental: Infusion group
Infusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time |
Single dose given 15 minutes before end of surgery
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)
Prazo: 5 minutes after operation
|
RASS is a 10-point scoring system used to assess patient's level of agitation and sedation: 4 levels for agitation, 1 level for normal (alert and calm), and 5 levels of sedation |
5 minutes after operation
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intraoperative heart rate
Prazo: Every 15 minutes along operation
|
Beats / minute |
Every 15 minutes along operation
|
|
Intraoperative mean arterial blood pressure
Prazo: Every 15 minutes along operation
|
mmHg |
Every 15 minutes along operation
|
|
Time of first rescue analgesic
Prazo: 5 minutes before first analgesic request
|
in minutes in minutes |
5 minutes before first analgesic request
|
|
Extubation time
Prazo: 3 minutes after removal of endotracheal tube
|
time interval between shutting off anesthetics to extubation (in minutes) |
3 minutes after removal of endotracheal tube
|
|
Postanesthesia care unit time
Prazo: 5 minutes after discharge from recovery unit
|
time interval from admission to PACU till patient scored ≥ 9 on Aldrete scale (ready to discharge) |
5 minutes after discharge from recovery unit
|
|
Incidence of use of midazolam
Prazo: 2 minutes after occurence of emergence agitation
|
Yes or no |
2 minutes after occurence of emergence agitation
|
|
Numerical rating score (NRS)
Prazo: Every 10 min in postanesthesia care unit
|
10 point scale where zero meaning "no pain" and 10 meaning "the worst pain imaginable" |
Every 10 min in postanesthesia care unit
|
|
Total amount of rescue analgesic
Prazo: 24 hours postoperative
|
in milligram |
24 hours postoperative
|
|
Boezaart Surgical Field Grading Scale
Prazo: 2 hours intraoperatively
|
endoscopically using the six-point score (0-5 Scale) where 0 - No bleeding, 1 - Slight bleeding, no suctioning needed, 2 - Slight bleeding, occasional suctioning needed, 3 - Moderate bleeding, frequent suctioning needed, visibility maintained, 4 - Heavy bleeding, constant suctioning needed, visibility impaired, 5 - Severe bleeding, uncontrolled, surgery impossible |
2 hours intraoperatively
|
|
Incidence of bradycardia
Prazo: 2 hours intraoperatively
|
Yes or no |
2 hours intraoperatively
|
|
Incidence of hypotension
Prazo: 2 hours intraoperatively
|
Yes or no when mean arterial blood pressure below 60 mmHg |
2 hours intraoperatively
|
|
Incidence of nausea
Prazo: 24 hours postoperative
|
Yes or no |
24 hours postoperative
|
|
Incidence of vomiting
Prazo: 24 hours postoperative
|
Yes or no |
24 hours postoperative
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Age
Prazo: 5 minutes before entering operation department
|
in years |
5 minutes before entering operation department
|
|
Sex
Prazo: 5 minutes before entering operation department
|
Male of female |
5 minutes before entering operation department
|
|
Weight
Prazo: 5 minutes before entering operation department
|
In kilogram |
5 minutes before entering operation department
|
|
Height
Prazo: 5 minutes before entering operation department
|
In centimeter |
5 minutes before entering operation department
|
|
Duration of surgery
Prazo: 5 minutes after end of surgery
|
In minutes |
5 minutes after end of surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yasser S Mostafa, MD, Fayoum University
- Cadeira de estudo: Mohamed A Shawky, MD, Fayoum University
Publicações e links úteis
Publicações Gerais
- Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.
- Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.
- Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026.
- Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.
- Zhu M, Wang H, Zhu A, Niu K, Wang G. Meta-analysis of dexmedetomidine on emergence agitation and recovery profiles in children after sevoflurane anesthesia: different administration and different dosage. PLoS One. 2015 Apr 13;10(4):e0123728. doi: 10.1371/journal.pone.0123728. eCollection 2015.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Complicações pós-operatórias
- Processos Patológicos
- Doenças Respiratórias
- Confusão
- Manifestações Neurocomportamentais
- Distúrbios Neurocognitivos
- Doenças Otorrinolaringológicas
- Delírio
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Delírio de emergência
- Doenças do Nariz
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Azoles
- Imidazoles
- Dexmedetomidina
Outros números de identificação do estudo
- R656
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .