Comparing the efficacy in the intravenous and sublingual administration of midazolam for the sedation of patients during upper gastrointestinal endoscopy

• Mohammad Kazem Amirbeigi ^[1] ; Mohsen Nasirian ^[1] ; Shekoufeh Behdad ^[2] ; Mohsen Akhondi Meybodi ^[3] ; Vahid Ramazani ^[4]
  1. [1] Department of Gastroenterology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
  2. [2] Departments of Anesthesiology, Pain Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
  3. [3] Department of Internal Medicine, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
  4. [4] Department of Pharmaceutics, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences

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• Localización: Academic Journal of Health Sciences: Medicina Balear, ISSN-e 2255-0560, Vol. 38, Nº. 2, 2023, págs. 37-42
• Idioma: inglés
• DOI: 10.3306/AJHS.2023.38.02.37
• Títulos paralelos:
  • Comparación de la eficacia en la administración intravenosa y sublingual de midazolam para la sedación de pacientes durante la endoscopia digestiva alta
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• Resumen
  • español

    Antecedentes: La endoscopia del tracto gastrointestinal superior (GI) es un procedimiento común para el diagnóstico y tratamiento de las enfermedades del tracto digestivo superior. Es necesario aliviar el dolor y las molestias durante la endoscopia. En nuestro estudio, se comparó la administración sublingual y la inyección de midazolam en cuanto a su eficacia en la sedación de pacientes sometidos a endoscopia gastrointestinal superior.

    Métodos: En este ensayo clínico doble ciego, 80 pacientes fueron divididos en dos grupos. El primer y el segundo grupo recibieron 2,5 mg de midazolam intravenoso y 5 mg de midazolam sublingual, respectivamente. Los pacientes fueron evaluados y comparados mediante cuestionarios estándar en términos de sedación, dolor/malestar y satisfacción. También se controlaron la presión arterial, la frecuencia cardíaca y la SPO2. Los datos se analizaron con el programa informático SPSS 16 utilizando la prueba de Tukey y el coeficiente de correlación de Spearman. El nivel de significación se consideró P<0,05.

    Resultados: Según los resultados, hubo una diferencia estadísticamente significativa entre los dos grupos en cuanto a la puntuación media de Ramsay tras la administración sublingual o la inyección. En el caso de la dosis doble en el grupo sublingual, esta puntuación fue superior a la del grupo intravenoso. No hubo diferencias estadísticamente significativas entre los dos grupos en términos de dolor y satisfacción. En ambos métodos, la diferencia entre las puntuaciones medias de sedación fue estadísticamente significativa antes y después del tratamiento. El efecto de cada método también fue significativo en la mejora de la puntuación de sedación. No hubo diferencias significativas entre los dos grupos en cuanto a la presión arterial sistólica y diastólica, la frecuencia cardíaca y la SPO2.

    Conclusiones: Como se concluyó, la doble dosis de midazolam sublingual tiene un efecto estadísticamente mayor sobre la sedación que la administración intravenosa. Los efectos de los dos métodos sobre la saturación de oxígeno, la frecuencia cardíaca y la presión arterial son estadísticamente similares.

  • English

    Background: Upper gastrointestinal (GI) endoscopy is a common procedure for the diagnosis and treatment of upper digestive tract diseases. Relief of pain and discomfort during endoscopy is necessary. In our study, the sublingual administration and the injection of midazolam were compared in terms of their efficacy in the sedation of patients undergoing upper gastrointestinal endoscopy.

    Methods: In this double-blind clinical trial, 80 patients were divided into two groups. The first and the second groups received 2.5 mg intravenous and 5 mg sublingual midazolam respectively. The patients were evaluated and compared using standard questionnaires in terms of sedation, pain/discomfort, and satisfaction. They were also monitored for blood pressure, heart rate and SPO2. The data were analyzed by the SPSS 16 software using Tukey’s test and Spearman’s correlation coefficient. The significance level was considered to be P<0.05.

    Results: According to the results, there was a statistically significant difference between the two groups in terms of the mean Ramsay score after sublingual administration or injection. For the double dose in the sublingual group, this score was higher than that in the intravenous group. There was no statistically significant difference between the two groups in terms of pain and satisfaction. In both methods, the difference between the mean sedation scores was statistically significant before and after the treatment. The effect of each method was also significant on the improvement of the sedation score. There was no significant difference between the two groups in terms of systolic and diastolic blood pressures, heart rate and SPO2.

    Conclusion: As it was concluded, double dose of sublingual midazolam has a statistically greater effect on sedation than intravenous administration. The effects of the two methods on oxygen saturation, heart rate and blood pressure are statistically similar.

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