RESUMO
Abstract Introduction Spinal infusions of either fentanyl or sufentanil have been reported in international reports, articles, and scientific events worldwide. This study aimed to determine whether intrathecal fentanyl or sufentanil offers safety in mortality and perioperative adverse events. Methods MEDLINE (via PubMed), EMBASE, CENTRAL (Cochrane library databases), gray literature, hand-searching, and clinicaltrials.gov were systematically searched. Randomized controlled trials with no language, data, or status restrictions were included, comparing the effectiveness and safety of adding spinal lipophilic opioid to local anesthetics (LAs). Data were pooled using the random-effects models or fixed-effect models based on heterogeneity. Results The initial search retrieved 4469 records; 3241 records were eligible, and 3152 articles were excluded after reading titles and abstracts, with a high agreement rate (98.6%). After reading the full texts, 76 articles remained. Spinal fentanyl and sufentanil significantly reduced postoperative pain and opioid consumption, increased analgesia and pruritus. Fentanyl, but not sufentanil, significantly reduced both postoperative nausea and vomiting, and postoperative shivering; compared to LAs alone. The analyzed studies did not report any case of in-hospital mortality related to spinal lipophilic opioids. The rate of respiratory depression was 0.7% and 0.8% when spinal fentanyl or sufentanil was added and when it was not, respectively. Episodes of respiratory depression were rare, uneventful, occurred intraoperatively, and were easily manageable. Conclusion There is moderate to high quality certainty that there is evidence regarding the safety and effectiveness of adding lipophilic opioids to LAs in spinal anesthesia.
Assuntos
Humanos , Fentanila/efeitos adversos , Raquianestesia/efeitos adversos , Dor Pós-Operatória , Sufentanil/efeitos adversos , Ensaios Clínicos Controlados não Aleatórios como Assunto , Analgésicos Opioides/efeitos adversos , Anestésicos Locais/efeitos adversosRESUMO
INTRODUCTION: Spinal infusions of either fentanyl or sufentanil have been reported in international reports, articles, and scientific events worldwide. This study aimed to determine whether intrathecal fentanyl or sufentanil offers safety in mortality and perioperative adverse events. METHODS: MEDLINE (via PubMed), EMBASE, CENTRAL (Cochrane library databases), gray literature, hand-searching, and clinicaltrials.gov were systematically searched. Randomized controlled trials with no language, data, or status restrictions were included, comparing the effectiveness and safety of adding spinal lipophilic opioid to local anesthetics (LAs). Data were pooled using the random-effects models or fixed-effect models based on heterogeneity. RESULTS: The initial search retrieved 4469 records; 3241 records were eligible, and 3152 articles were excluded after reading titles and abstracts, with a high agreement rate (98.6%). After reading the full texts, 76 articles remained. Spinal fentanyl and sufentanil significantly reduced postoperative pain and opioid consumption, increased analgesia and pruritus. Fentanyl, but not sufentanil, significantly reduced both postoperative nausea and vomiting, and postoperative shivering; compared to LAs alone. The analyzed studies did not report any case of in-hospital mortality related to spinal lipophilic opioids. The rate of respiratory depression was 0.7% and 0.8% when spinal fentanyl or sufentanil was added and when it was not, respectively. Episodes of respiratory depression were rare, uneventful, occurred intraoperatively, and were easily manageable. CONCLUSION: There is moderate to high quality certainty that there is evidence regarding the safety and effectiveness of adding lipophilic opioids to LAs in spinal anesthesia.
Assuntos
Raquianestesia , Fentanila , Humanos , Fentanila/efeitos adversos , Raquianestesia/efeitos adversos , Analgésicos Opioides/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Sufentanil/efeitos adversos , Anestésicos Locais/efeitos adversos , Dor Pós-OperatóriaRESUMO
Abstract Background Postoperative pain represents an important concern when remifentanil is used for total intravenous anesthesia because of its ultrashort half-life. Longer acting opioids, such as sufentanil, have been used during induction of remifentanil-based total intravenous anesthesia as a means to overcome this shortcoming. However, the effectiveness and safety of such strategy still lacks evidence from randomized clinical trials. Hence, we aimed to assess the postoperative analgesic efficacy and safety of a single dose of sufentanil administered during the induction of remifentanil-based total intravenous anesthesia. Methods Forty patients, scheduled for elective open abdominal surgery, were randomized to receive remifentanil-based total intravenous anesthesia with or without a single dose of sufentanil upon induction. We assessed the postoperative morphine consumption administered through a patient-controlled analgesia pump. Self-reported pain scores and the occurrence of nausea, vomiting, pruritus, agitation, somnolence and respiratory depression were also assessed up to 2 days after surgery. Results The mean difference between the sufentanil and control groups regarding morphine consumption in the post-anesthetic care unit and at 12, 24 and 48 h after surgery were -7.2 mg (95%CI: -12.5 to -2.1, p < 0.001), -3.9 mg (95%CI: -11.9 to 4.7, p = 0.26), -0.6 mg (95%CI: (-12.7 to 12.7, p = 0.80), and -1.8 mg (95%CI: (-11.6 to 15.6, p = 0.94), respectively. Neither self-reported pain nor the incidence of adverse events were significantly different between groups at any time point. Conclusion Our findings suggest that the administration of sufentanil during induction of remifentanil-based total intravenous anesthesia is associated with decreased early postoperative opioid consumption.
Resumo Justificativa A dor pós-operatória é uma grande preocupação quando o remifentanil é usado para anestesia intravenosa total devido à sua meia-vida ultracurta. Os opioides de ação mais longa, como o sufentanil, têm sido usados durante a indução de anestesia intravenosa total à base de remifentanil como um meio de superar essa deficiência. Porém, a eficácia e segurança de tal estratégia ainda precisam de evidências advindas de ensaios clínicos randômicos. Portanto, objetivamos avaliar a eficácia analgésica e a segurança pós-operatória de uma dose única de sufentanil administrada durante a indução de anestesia intravenosa total à base de remifentanil. Métodos Quarenta pacientes eletivamente agendados para cirurgia abdominal aberta foram randomizados para receber anestesia intravenosa total à base de remifentanil, com ou sem uma dose única de sufentanil, após a indução da anestesia. Avaliamos o consumo de morfina no pós-operatório, administrado através de uma bomba de analgesia controlada pelo paciente. Os escores de dor autorrelatados e a ocorrência de náusea, vômito, prurido, agitação, sonolência e depressão respiratória também foram avaliados até dois dias após a cirurgia. Resultados A diferença média entre os grupos sufentanil e controle em relação ao consumo de morfina em sala de recuperação pós-anestesia e após 12, 24 e 48 horas da cirurgia foi de -7,2 mg (IC 95%: -12,5 a -2,1, p < 0,001), -3,9 mg (IC 95%: -11,9 a 4,7, p = 0,26), -0,6 mg (IC 95%: (-12,7 a 12,7, p = 0,80) e -1,8 mg (IC 95%: -11,6 para 15,6, p = 0,94), respectivamente. Não houve diferença significativa tanto nos escores de dor autorrelatados, quanto na incidência de eventos adversos entre os grupos. Conclusão Nossos achados sugerem que a administração de sufentanil durante a indução de anestesia intravenosa total à base de remifentanil está associada à redução do consumo de opioides no pós-operatório imediato.
Assuntos
Humanos , Masculino , Feminino , Adulto , Idoso , Dor Pós-Operatória/prevenção & controle , Sufentanil/administração & dosagem , Remifentanil/administração & dosagem , Analgésicos Opioides/administração & dosagem , Anestesia Intravenosa/métodos , Fatores de Tempo , Método Duplo-Cego , Analgesia Controlada pelo Paciente/estatística & dados numéricos , Sufentanil/efeitos adversos , Remifentanil/efeitos adversos , Pessoa de Meia-Idade , Morfina/administração & dosagemRESUMO
BACKGROUND: Postoperative pain represents an important concern when remifentanil is used for total intravenous anesthesia because of its ultrashort half-life. Longer acting opioids, such as sufentanil, have been used during induction of remifentanil-based total intravenous anesthesia as a means to overcome this shortcoming. However, the effectiveness and safety of such strategy still lacks evidence from randomized clinical trials. Hence, we aimed to assess the postoperative analgesic efficacy and safety of a single dose of sufentanil administered during the induction of remifentanil-based total intravenous anesthesia. METHODS: Forty patients, scheduled for elective open abdominal surgery, were randomized to receive remifentanil-based total intravenous anesthesia with or without a single dose of sufentanil upon induction. We assessed the postoperative morphine consumption administered through a patient-controlled analgesia pump. Self-reported pain scores and the occurrence of nausea, vomiting, pruritus, agitation, somnolence and respiratory depression were also assessed up to 2 days after surgery. RESULTS: The mean difference between the sufentanil and control groups regarding morphine consumption in the post-anesthetic care unit and at 12, 24 and 48h after surgery were -7.2mg (95%CI: -12.5 to -2.1, p<0.001), -3.9mg (95%CI: -11.9 to 4.7, p=0.26), -0.6mg (95%CI: (-12.7 to 12.7, p=0.80), and -1.8mg (95%CI: (-11.6 to 15.6, p=0.94), respectively. Neither self-reported pain nor the incidence of adverse events were significantly different between groups at any time point. CONCLUSION: Our findings suggest that the administration of sufentanil during induction of remifentanil-based total intravenous anesthesia is associated with decreased early postoperative opioid consumption.
Assuntos
Analgésicos Opioides/administração & dosagem , Anestesia Intravenosa/métodos , Dor Pós-Operatória/prevenção & controle , Remifentanil/administração & dosagem , Sufentanil/administração & dosagem , Adulto , Idoso , Analgesia Controlada pelo Paciente/estatística & dados numéricos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Morfina/administração & dosagem , Remifentanil/efeitos adversos , Sufentanil/efeitos adversos , Fatores de TempoRESUMO
Abstract A double blind randomized clinical trial of sufentanil as an adjunct in spinal anesthesia for cesarean section and, thereby, be able to reduce the dose of bupivacaine, a local anesthetic, with the same result of an anesthetic block with higher doses but with fewer perioperative side effects, such as hypotension.
Resumo Ensaio clínico randomizado duplamente encoberto sobre o uso do sufentanil como adjuvante em raquianestesia para cesariana e, possibilitando a redução da dose do anestésico local, a bupivacaína, com o mesmo resultado de bloqueio anestésico com doses mais elevadas, mas com menos efeitos colaterais no perioperatório, como hipotensão.
Assuntos
Humanos , Feminino , Gravidez , Recém-Nascido , Adolescente , Adulto , Adulto Jovem , Bupivacaína/administração & dosagem , Bupivacaína/efeitos adversos , Cesárea/métodos , Sufentanil/administração & dosagem , Sufentanil/efeitos adversos , Anestésicos Intravenosos/administração & dosagem , Anestésicos Intravenosos/efeitos adversos , Anestesia Obstétrica/métodos , Raquianestesia/métodos , Anestésicos Locais/administração & dosagem , Anestésicos Locais/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Método Duplo-Cego , Hipotensão/prevenção & controle , Complicações Intraoperatórias/prevenção & controleRESUMO
A double blind randomized clinical trial of sufentanil as an adjunct in spinal anesthesia for cesarean section and, thereby, be able to reduce the dose of bupivacaine, a local anesthetic, with the same result of an anesthetic block with higher doses but with fewer perioperative side effects, such as hypotension.
Assuntos
Anestesia Obstétrica/métodos , Raquianestesia/métodos , Anestésicos Intravenosos , Anestésicos Locais , Bupivacaína , Cesárea/métodos , Sufentanil , Adolescente , Adulto , Anestésicos Intravenosos/administração & dosagem , Anestésicos Intravenosos/efeitos adversos , Anestésicos Locais/administração & dosagem , Anestésicos Locais/efeitos adversos , Bupivacaína/administração & dosagem , Bupivacaína/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Hipotensão/prevenção & controle , Recém-Nascido , Complicações Intraoperatórias/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Gravidez , Sufentanil/administração & dosagem , Sufentanil/efeitos adversos , Adulto JovemRESUMO
PURPOSE: To evaluate the efficacy and side-effects of fentanyl and sufentanil combined with hyperbaric spinal bupivacaine in elective cesarean section. METHODS: A prospective, randomized, double-blind study with 64 term parturients, distributed into 2 groups according to the opioid combined with hyperbaric bupivacaine 0.5% (10mg): GF - fentanyl (25 µg) and GS - sufentanil (5.0 µg). The latency and maximum sensory block level; degree and duration of motor block; duration and quality of analgesia; maternal-fetal repercussions were evaluated. This was an intention-to-treat analysis with a 5% significance level. RESULTS: The latency period, maximum sensory block level, motor block degree and perioperative analgesia were similar in both groups. Motor block and analgesia had a longer duration in the sufentanil group. Maternal adverse effects and neonatal repercussions were similar. The incidence of hypotension was higher in the fentanyl group. In both groups, there was a predominance of patients who were awake and either calm or sleepy. CONCLUSIONS: The addition of fentanyl and sufentanil to hyperbaric subarachnoid bupivacaine was shown to be effective for the performance of cesarean section, and safe for the mother and fetus. Analgesia was more prolonged with sufentanil.
Assuntos
Analgésicos Opioides/administração & dosagem , Anestesia Obstétrica/métodos , Anestésicos Locais/administração & dosagem , Bupivacaína/administração & dosagem , Cesárea/métodos , Fentanila/administração & dosagem , Sufentanil/administração & dosagem , Adulto , Analgésicos Opioides/efeitos adversos , Análise de Variância , Raquianestesia/métodos , Anestésicos Locais/efeitos adversos , Bupivacaína/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Fentanila/efeitos adversos , Humanos , Duração da Cirurgia , Gravidez , Estudos Prospectivos , Reprodutibilidade dos Testes , Sufentanil/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: To evaluate the efficacy and side-effects of fentanyl and sufentanil combined with hyperbaric spinal bupivacaine in elective cesarean section. METHODS: A prospective, randomized, double-blind study with 64 term parturients, distributed into 2 groups according to the opioid combined with hyperbaric bupivacaine 0.5% (10mg): GF - fentanyl (25µg) and GS - sufentanil (5.0µg). The latency and maximum sensory block level; degree and duration of motor block; duration and quality of analgesia; maternal-fetal repercussions were evaluated. This was an intention-to-treat analysis with a 5% significance level. RESULTS: The latency period, maximum sensory block level, motor block degree and perioperative analgesia were similar in both groups. Motor block and analgesia had a longer duration in the sufentanil group. Maternal adverse effects and neonatal repercussions were similar. The incidence of hypotension was higher in the fentanyl group. In both groups, there was a predominance of patients who were awake and either calm or sleepy. CONCLUSIONS: The addition of fentanyl and sufentanil to hyperbaric subarachnoid bupivacaine was shown to be effective for the performance of cesarean section, and safe for the mother and fetus. Analgesia was more prolonged with sufentanil. .
Assuntos
Adulto , Feminino , Humanos , Gravidez , Analgésicos Opioides/administração & dosagem , Anestesia Obstétrica/métodos , Anestésicos Locais/administração & dosagem , Bupivacaína/administração & dosagem , Cesárea/métodos , Fentanila/administração & dosagem , Sufentanil/administração & dosagem , Análise de Variância , Analgésicos Opioides/efeitos adversos , Raquianestesia/métodos , Anestésicos Locais/efeitos adversos , Bupivacaína/efeitos adversos , Método Duplo-Cego , Combinação de Medicamentos , Fentanila/efeitos adversos , Duração da Cirurgia , Estudos Prospectivos , Reprodutibilidade dos Testes , Sufentanil/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE:To evaluate the efficacy and side-effects of fentanyl and sufentanil combined with hyperbaric spinal bupivacaine in elective cesarean section.METHODS:A prospective, randomized, double-blind study with 64 term parturients, distributed into 2 groups according to the opioid combined with hyperbaric bupivacaine 0.5% (10mg): GF - fentanyl (25µg) and GS - sufentanil (5.0µg). The latency and maximum sensory block level; degree and duration of motor block; duration and quality of analgesia; maternal-fetal repercussions were evaluated. This was an intention-to-treat analysis with a 5% significance level.RESULTS:The latency period, maximum sensory block level, motor block degree and perioperative analgesia were similar in both groups. Motor block and analgesia had a longer duration in the sufentanil group. Maternal adverse effects and neonatal repercussions were similar. The incidence of hypotension was higher in the fentanyl group. In both groups, there was a predominance of patients who were awake and either calm or sleepy.CONCLUSIONS:The addition of fentanyl and sufentanil to hyperbaric subarachnoid bupivacaine was shown to be effective for the performance of cesarean section, and safe for the mother and fetus. Analgesia was more prolonged with sufentanil.(AU)
Assuntos
Humanos , Feminino , Gravidez , Gestantes , Fentanila/efeitos adversos , Fentanila/análise , Sufentanil/efeitos adversos , Sufentanil/análise , Bupivacaína , Cesárea , Espaço Subaracnóideo , Anestésicos Combinados , Analgésicos Opioides , Distribuição AleatóriaRESUMO
JUSTIFICATIVA E OBJETIVO: Tremores são causa de desconforto e insatisfação das pacientes submetidas à cesariana. O objetivo deste estudo foi analisar o impacto do uso de sufentanil intratecal na incidência de tremores após cesarianas. PACIENTES E MÉTODOS: Em um ensaio clínico prospectivo aleatório encoberto, foram incluídas no estudo gestantes submetidas à cesariana sob raquianestesia. Foram excluídas as gestantes em trabalho de parto, febris, obesas, com doença hipertensiva da gravidez, com falha do bloqueio anestésico ou complicação cirúrgica. As pacientes foram distribuídas aleatoriamente em dois grupos. No Grupo I foram administrados 10 mg de bupivacaína 0,5% hiperbárica associados a 80 mcg de morfina e 2,5 mcg de sufentanil. No Grupo II foram administrados 10 mg de bupivacaína 0,5% hiperbárica associados a 80 mcg de morfina. Na Sala de Recuperação Pós-Anestésica as pacientes foram avaliadas quanto à presença de sinais de tremores por observador que desconhecia o grupo ao qual a paciente havia sido alocada. RESULTADOS: A amostra constou de 80 pacientes. Em ambos os grupos houve diminuição na temperatura axilar das pacientes após a cesariana (p < 0,001). Essa diminuição não se mostrou diferente entre os grupos (p < 0,21). No Grupo I a incidência de tremores foi de 13/40 (32,5%) pacientes e no Grupo II foi de 25/40 (62,5%) (p < 0,007) - Risco Relativo 0,53 (IC 95% 0,32-0,87). CONCLUSÕES: Sugere-se que a adição de sufentanil à bupivacaína hiperbárica e morfina durante raquianestesia para cesariana proporciona diminuição na incidência de tremores no período pós-operatório imediato.
BACKGROUND AND OBJECTIVES: Shivering is a cause of discomfort and dissatisfaction in patients undergoing cesarean section. The objective of this study paper was to assess the impact of intrathecal administration of sufentanil on the incidence of shivering after cesarean section. METHOD: In a prospective blinded, randomized clinical trial, pregnant women undergoing cesarean section under spinal anesthesia were enrolled. Pregnant women in labor, febrile, obese, with pregnancy-induced hypertension, anesthetic block failure or surgical complications were excluded. Patients were randomly assigned to two groups. In Group I, 10 mg of 0.5% hyperbaric bupivacaine combined with 80 mcg of morphine and 2.5 mcg of sufentanil were administered. In Group II, 10 mg of 0.5% hyperbaric bupivacaine combined with 80 mcg of morphine were administered. In the post-anesthesia care unit, patients were evaluated for signs of shivering by an investigator blinded to the patient's group allocation. RESULTS: The sample consisted of 80 patients. In both groups there was a decrease in axillary temperature of patients after cesarean section (p < 0.001). This decrease was not different between groups (p < 0.21). In Group I, the incidence of tremor was 32.5% (13/40) and in Group II it was 62.5% (25/40) (p < 0.007); RR 0.53 (CI 95% 0.32-0.87). CONCLUSIONS: It has been suggested that the addition of sufentanil to hyperbaric bupivacaine and morphine during spinal anesthesia for cesarean section provides a decrease in the incidence of shivering in the immediate postoperative period.
JUSTIFICATIVA Y OBJETIVOS: Los temblores son provenientes de la incomodidad y de la insatisfacción de las pacientes sometidas a la cesárea. El objetivo de este estudio, fue analizar el impacto del uso de sufentanilo intratecal en la incidencia de temblores posteriores a las cesáreas. PACIENTES Y MÉTODOS: En un ensayo clínico prospectivo randomizado encubierto, se incluyeron en el estudio embarazadas sometidas a la cesárea bajo raquianestesia. Se excluyeron las embarazadas en trabajo de parto, febriles, obesas, con enfermedad hipertensiva del embarazo, con fallo en el bloqueo anestésico o complicación quirúrgica. Las pacientes se distribuyeron aleatoriamente en dos grupos. En el Grupo I, fueron administrados 10 mg de bupivacaína al 0,5% hiperbárica asociados a 80 mcg de morfina y 2,5 mcg de sufentanilo. En el Grupo II, fueron administrados 10 mg de bupivacaína al 0,5% hiperbárica asociados a 80 mcg de morfina. En la Sala de Recuperación Postanestésica, las pacientes se evaluaron en cuanto a la presencia de signos de temblores por un observador que no conocía el grupo en el cual la paciente había sido ubicada. RESULTADOS: La muestra constó de 80 pacientes. En los dos grupos se produjo una reducción en la temperatura axilar de las pacientes después de la cesárea (p < 0,001). Esa disminución no fue diferente entre los grupos (p < 0,21). En el Grupo I la incidencia de temblores fue de 13/40 (32,5%) pacientes y en el Grupo II de 25/40 (62,5%) (p < 0,007) - Riesgo Relativo 0,53 (IC 95% 0,32-0,87). CONCLUSIONES: Sugerimos que la adición de sufentanilo a la bupivacaína hiperbárica y morfina durante la raquianestesia para la cesárea, proporciona la disminución en la incidencia de temblores en el período postoperatorio inmediato.