The effect of 1-mg versus 3-mg granisetron on shivering and nausea in cesarean section: a randomized, controlled, triple-blind, clinical trial
O efeito de 1 mg versus 3 mg de granisetrona sobre tremor e náuseas em cesariana: ensaio clínico randomizado, controlado, triplo-cego
Laleh Dehghanpisheh, Simin Azemati, Mahdi Hamedi, Zeinabsadat Fattahisaravi
Abstract
Introduction
Intra- and post-operative nausea, vomiting and shivering are mentioned as the most common problem following spinal anesthesia. The aim of this study is to compare two different doses of granisetron to control the shivering, nausea, and vomiting caused by spinal anesthesia in women undergoing C/S.
Method
This study is a randomized, triple-blind clinical trial. The participants received 1-mg or 3-mg granisetron. Women who underwent elective C/S were enrolled. Inclusion criteria were grade I or II of physical status classification system according to the American Society of Anesthesiologists guideline and age range of 18–40. Primary outcome was changes in the score of shivering and nausea and vomiting. Secondary outcomes were Apgar score, mean arterial pressure, systolic blood pressure, diastolic blood pressure, temperature and heart rate.
Results
According to binary logistic regression, the incidence of shivering (6.9% vs. 1.5%; p-value = 0.049) and nausea and vomiting (19.2% vs. 9.2%; p-value = 0.024) was significantly higher in patients received 1-mg granisetron in comparison with 3-mg granisetron. Multinomial logistic regression showed that, the occurrence of shivering and nausea and vomiting were not associated with dose of granisetron. There was no significant difference between the age and Apgar score of 1 (p = 0.908) and 5 (p = 0.843) minute (s) between the two groups.
Conclusion
This study showed that although 3-mg of granisetron reduces the incidence of intra- and post-operative shivering, nausea and vomiting after spinal anesthesia in comparison with 1-mg of granisetron, but the difference was not statistically significant.
Keywords
Resumo
Introdução: Náuseas, vômitos e tremor intra e pós-operatórios são mencionados como os problemas mais comuns após a raquianestesia. O objetivo deste estudo é comparar duas doses diferentes de granisetron para controlar os tremores, náuseas e vômitos causados pela raquianestesia em mulheres submetidas à cesariana. Método: Este estudo é um ensaio clínico randomizado, triplo-cego. Os participantes receberam 1 mg ou 3 mg de granisetrona. As mulheres que foram submetidas a cesariana eletiva foram inscritas. Os critérios de inclusão foram grau I ou II do sistema de classificação do estado físico de acordo com a diretriz da Sociedade Americana de Anestesiologistas e faixa etária de 18 a 40 anos. O desfecho primário foi alterações na pontuação de tremor e náuseas e vômitos. Os desfechos secundários foram escore de Apgar, pressão arterial média, pressão arterial sistólica, pressão arterial diastólica, temperatura e frequência cardíaca. Resultados: De acordo com a regressão logística binária, a incidência de tremor (6,9% vs 1,5%; valor p=0,049) e náuseas e vômitos (19,2% vs 9,2%; valor p=0,024) foi significativamente maior nos pacientes que receberam 1 mg de granisetrona em comparação com 3 mg de granisetrona. A regressão logística multinomial mostrou que a ocorrência de tremor, náuseas e vômitos não esteve associada à dose de granisetrona. Não houve diferença significativa entre a idade e o índice de Apgar de 1 (p=0,908) e 5 (p=0,843) minuto(s) entre os dois grupos. Conclusão: Este estudo mostrou que, embora 3 mg de granisetrona reduza a incidência de tremores, náuseas e vômitos intra e pós-operatórios após raquianestesia em comparação com 1 mg de granisetrona, mas a diferença não foi estatisticamente significativa.
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References
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