BACKGROUND: An increased anxiety may be associated with a higher risk of surgical site infection (SSI), but there is little objective data on the effect of preoperative anxiolytic interventions on SSI. To address this issue, we evaluated the effects of preoperative diazepam on postoperative SSI following abdominal hysterectomy. METHODS: This randomized, double-blinded, placebo-controlled study included 130 patients, American Society of Anesthesiologist physical status 1 or 2. Patients were randomly assigned to receive either oral diazepam 10 mg (n = 65) or placebo (n = 65) the night before and 1 hour prior to surgery. The assessment instruments were the Visual Analogue Scale and the State-Trait Anxiety Inventory. SSI was diagnosed according to the criteria of the Centers for Disease Control and Prevention with standard follow-up of 30 days. RESULTS: The relative risk (RR) was 1.79 (95% confidence interval [CI]: 1.31-2.43), and the number of patients that needed to be treated was 5.2 (95% CI: 2.74-50.76) to prevent 1 additional SSI. The RR for SSI in placebo-treated patients with high postoperative anxiety was 1.65 (95% CI: 1.07-2.56). CONCLUSION:Diazepam-treated patients showed lower postoperative anxiety and lower incidence of SSI up to 30 days after surgery compared with placebo in patients undergoing abdominal hysterectomy.
RCT Entities:
BACKGROUND: An increased anxiety may be associated with a higher risk of surgical site infection (SSI), but there is little objective data on the effect of preoperative anxiolytic interventions on SSI. To address this issue, we evaluated the effects of preoperative diazepam on postoperative SSI following abdominal hysterectomy. METHODS: This randomized, double-blinded, placebo-controlled study included 130 patients, American Society of Anesthesiologist physical status 1 or 2. Patients were randomly assigned to receive either oral diazepam 10 mg (n = 65) or placebo (n = 65) the night before and 1 hour prior to surgery. The assessment instruments were the Visual Analogue Scale and the State-Trait Anxiety Inventory. SSI was diagnosed according to the criteria of the Centers for Disease Control and Prevention with standard follow-up of 30 days. RESULTS: The relative risk (RR) was 1.79 (95% confidence interval [CI]: 1.31-2.43), and the number of patients that needed to be treated was 5.2 (95% CI: 2.74-50.76) to prevent 1 additional SSI. The RR for SSI in placebo-treated patients with high postoperative anxiety was 1.65 (95% CI: 1.07-2.56). CONCLUSION:Diazepam-treated patients showed lower postoperative anxiety and lower incidence of SSI up to 30 days after surgery compared with placebo in patients undergoing abdominal hysterectomy.