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Dexmedetomidina e agitação após cirurgia nasal

26 de setembro de 2026 atualizado por: Yasser S Mostafa, MD, Fayoum University Hospital

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

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

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

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:
        • Contato:

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 a 50 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

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

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: 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

An infusion given all through intraoperative time

Outros nomes:
  • Infusão de dexmedetomidina
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:
  • Bolus de dexmedetomidina

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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Yasser S Mostafa, MD, Fayoum University
  • Cadeira de estudo: Mohamed A Shawky, MD, Fayoum University

Publicações e links úteis

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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)

1 de agosto de 2025

Conclusão Primária (Estimado)

1 de novembro de 2026

Conclusão do estudo (Estimado)

1 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

4 de março de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de março de 2025

Primeira postagem (Real)

10 de março de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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