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Effect of Remifentanil on the Recovery Profile After Prolonged Head and Neck Surgery

14 de abril de 2015 atualizado por: Suhitharan Thangavelautham, Singapore General Hospital
Opioid tolerance in the perioperative period is inevitable especially with ultra-short acting agents such as remifentanil. Existing evidence had shown that opioid induced hyperalgesia due to neuroplastic changes in the central as well as peripheral nervous system leads to sensitization of pro-nociceptive pathways. However there has been a controversy of occurrence of such tolerance following the use of remifentanil and the quality of recovery as compared to conventional opioids. The investigators evaluated the occurrence of opioid tolerance and other significant adverse effects with remifentanil in subjects undergoing head and neck surgeries. The investigators studied ASA physical status I and II adult subjects undergoing elective head and neck procedures, under general anesthesia with minimum expected duration of 2 hours. The remifentanil infusion was used in one group and intermittent boluses of morphine or fentanyl administered in another group. They were evaluated for immediate post-operative pain by using numerical rating scale (NRS), the opioid consumption, post-operative nausea, vomiting, other significant adverse effects of remifentanil and the time to discharge from PACU.

Visão geral do estudo

Descrição detalhada

We have studied 222 of you between the age of 21 and 80 years, over a period of 2 years at Singapore General Hospital, Singapore. All of you were ASA I to II and scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia. The methodology of this observational study was approved by the International review Board at Singapore General Hospital, Singapore. Informed consent was obtained from you prior to the procedure. If you had previous history of either drug or alcohol abuse, have been using opioids for long term, mental disorder with difficult to understand pain scoring system, ASA physical status of III and above, your surgical procedure warranting elective postoperative ventilation you would have been excluded from this study. The study was not randomized and the choice of intra-operative opioids were left to the discretion of anesthesiologist attending you.

You were not premedicated and instructed about 11 point numerical rating score after reaching induction room. Upon arrival in the operating room, you were monitored with EKG, non-invasive arterial pressure and pulse oxymetry. The attending anesthesiologist gave you either Remifentanil or conventional opioids at standard doses from the induction of anesthesia to end of surgery. Sevoflurane, desflurane or isoflurane with oxygen air mixture were utilized to maintain anesthesia at the minimum alveolar concentration of 0.8 to 1.2 . Choice of opioid, volatile agent, muscle relaxants, airway was left to the discretion of the anesthesiologist attending the patient. Parameters including type of volatile anesthetic agent, method of air way establishment, the duration of surgery, the remifentanil used (microgram.kg-1 ) and amount of morphine or fentanyl (microgram.kg-1) were documented. Upon arrival to the PACU you were assessed for the pain.

For the first 15 minutes behavioral score (0 - calm patient with no verbal or behavioral manifestation of pain, 1 - behavioral or verbal expression of pain, and 2 - intense behavioral or verbal manifestation [crying or extreme agitation]) were utilized and subsequently numerical rating scale (NRS) was used for every 5 minutes until discharge from the PACU.

Intravenous morphine or fentanyl was used to treat immediate post-operative pain in PACU till the NRS is less than or equal to 3 as per PACU acute pain management protocol. Maximum NRS of pain, amount of morphine or fentanyl used for rescue analgesia, occurrence of either nausea or vomiting and the antiemetic used was gathered every 15 minutes. Upon discharge from the PACU, total opioids consumed, duration of the PACU (defined by time since admission to decision made for discharge by PACU anesthesiologists, to rule out the prolong PACU stay from other reasons) and occurrence of other potential side effects that affect the quality of recovery such as drowsy, nausea, vomiting, shivering and evidence of respiratory suppression ( desaturation or bradypnea ) were documented.

Our primary outcome was amount of opioids used in PACU and the secondary outcomes were the duration of PACU stay and the adverse effects of remifentanil that influence the recovery as stated above.

Tipo de estudo

Observacional

Inscrição (Real)

222

Contactos e Locais

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Locais de estudo

      • Singapore, Cingapura, 169608
        • Department of Anesthesia Singapore General Hospital

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

21 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

We studied 222 adult subjects between 21 and 80 years, over two years at Singapore General Hospital, Singapore. All subjects were ASA I to II and scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia.

Descrição

Inclusion Criteria:

Patients with ASA I to II, scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia

Exclusion Criteria:

previous history of either drug or alcohol abuse those who have been using opioids for long term mental disorder with difficult to understand pain scoring system ASA physical status of III and above surgical procedure warranting elective postoperative ventilation

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

  • Modelos de observação: Controle de caso
  • Perspectivas de Tempo: Prospectivo

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
remifentanil group
Group received intra op remifentanil infusion
The remifentanil infusion was used intra operatively in remifentanil group and intermittent boluses of morphine or fentanyl administered for conventional opioid group
conventional opioid gropup
Group received only conventional opioids and No infusion of remifentanil

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Amount of opioids used in PACU in morphine equivalent
Prazo: 90 minutes
average time spent in PACU
90 minutes

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Duration of PACU
Prazo: 90 minutes
average time spent in PACU
90 minutes
Adverse effects of remifentanil
Prazo: 90 minutes
Occurrence of following adverse events such Drowsy, nausea, vomiting, shivering and evidence of respiratory suppression ( desaturation or bradypnea ) were documented.
90 minutes

Colaboradores e Investigadores

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

Publicações e links úteis

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Publicações Gerais

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

1 de agosto de 2011

Conclusão Primária (Real)

1 de julho de 2013

Conclusão do estudo (Real)

1 de julho de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

7 de abril de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

14 de abril de 2015

Primeira postagem (Estimativa)

15 de abril de 2015

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

15 de abril de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de abril de 2015

Última verificação

1 de abril de 2015

Mais Informações

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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