OBJECTIVE: The objective of this study was to assess the role of midazolam in reducing surgical stress as measured using subjective and objective variables. STUDY DESIGN: The study was a double-blind randomized controlled trial. Thirty-eight male patients undergoing surgical removal of third molars under general anesthesia were recruited for this study, each patient was given premedication (midazolam or placebo) and subjective variables (HAD scale) were obtained and objective variables (salivary cortisol samples and vital signs) were collected pre-, peri-, and postoperatively. The salivary samples were analyzed by direct immunofluorimetric assay using the "DELFIA" system. RESULTS: There were no significant differences in anxiety between the treatment group and the control group before the administration of the premedication. Following the administration of premedication, the majority of the control group showed high cortisol levels on the day of surgery, compared with relatively low cortisol levels in the majority of the treatment group. A few patients in the control group gave a placebo effect (sedative effect) and a number of the treatment group were unresponsive to the drug. There was a slight drop in the blood pressure and respiration rate with a slight increase in the heart rate in the treatment group; however these results were not statistically significant. The HAD scores were not statistically different between the 2 groups. CONCLUSION:Midazolam has proved to be very successful in reducing anxiety and stress pre-, peri-, and postoperatively with no significant effect on the vital signs of a healthy patient. Salivary cortisol technique is an easy, noninvasive method to assess anxiety and stress level in patients undergoing surgery.
RCT Entities:
OBJECTIVE: The objective of this study was to assess the role of midazolam in reducing surgical stress as measured using subjective and objective variables. STUDY DESIGN: The study was a double-blind randomized controlled trial. Thirty-eight male patients undergoing surgical removal of third molars under general anesthesia were recruited for this study, each patient was given premedication (midazolam or placebo) and subjective variables (HAD scale) were obtained and objective variables (salivary cortisol samples and vital signs) were collected pre-, peri-, and postoperatively. The salivary samples were analyzed by direct immunofluorimetric assay using the "DELFIA" system. RESULTS: There were no significant differences in anxiety between the treatment group and the control group before the administration of the premedication. Following the administration of premedication, the majority of the control group showed high cortisol levels on the day of surgery, compared with relatively low cortisol levels in the majority of the treatment group. A few patients in the control group gave a placebo effect (sedative effect) and a number of the treatment group were unresponsive to the drug. There was a slight drop in the blood pressure and respiration rate with a slight increase in the heart rate in the treatment group; however these results were not statistically significant. The HAD scores were not statistically different between the 2 groups. CONCLUSION:Midazolam has proved to be very successful in reducing anxiety and stress pre-, peri-, and postoperatively with no significant effect on the vital signs of a healthy patient. Salivary cortisol technique is an easy, noninvasive method to assess anxiety and stress level in patients undergoing surgery.
Authors: Hécio Henrique Araújo de Morais; Jimmy Charles Melo Barbalho; Ricardo José de Holanda Vasconcellos; Fabricio Souza Landim; Fábio Andrey da Costa Araújo; Tasiana Guedes de Souza Dias Journal: Oral Maxillofac Surg Date: 2015-02-25