BACKGROUND: Anxiety can complicate any outpatient procedure by causing elevation in blood pressure and heart rate with resultant increase in intraoperative and postoperative bleeding. Anxiety may also reduce patient satisfaction with the surgical experience. Midazolam is an efficacious short-acting benzodiazepine with an excellent safety record. However, little experience is documented on the use of midazolam in outpatient dermatologic surgery. OBJECTIVE: To establish the safety and efficacy of oral midazolam in healthy patients undergoing Mohs micrographic surgery. METHODS:Patients undergoing outpatient Mohs surgery were randomized in a double-blind, placebo-controlled study of single-dose midazolam for efficacy and safety in producing anxiolysis of short duration. A subpopulation of patients was evaluated prospectively in a nonrandomized arm of the study. Data on vital signs, anxiety, adverse events, and overall satisfaction were collected and compared using analysis of covariance model. RESULTS:Forty-four patients were randomized and 31 patients were enrolled in the prospective arm. Socioeconomic and surgical characteristics were similar among the groups. At 60 minutes, there was a clinically and statistically significant reduction in anxiety and alertness in both randomized and prospective arms. There were no major adverse events. Patients in all 3 groups were equally satisfied with their experience. LIMITATIONS: Few patients with high perioperative anxiety were willing to participate in a randomized controlled trial of anxiolytic medication. CONCLUSIONS:Midazolam is safe and efficacious in perioperative anxiolysis for healthy patients undergoing outpatient Mohs micrographic surgery. Midazolam offers the benefits of amnesia, reduced alertness, and reduced blood pressure with no clinically significant adverse effects. Copyright Â
RCT Entities:
BACKGROUND:Anxiety can complicate any outpatient procedure by causing elevation in blood pressure and heart rate with resultant increase in intraoperative and postoperative bleeding. Anxiety may also reduce patient satisfaction with the surgical experience. Midazolam is an efficacious short-acting benzodiazepine with an excellent safety record. However, little experience is documented on the use of midazolam in outpatient dermatologic surgery. OBJECTIVE: To establish the safety and efficacy of oral midazolam in healthy patients undergoing Mohs micrographic surgery. METHODS:Patients undergoing outpatient Mohs surgery were randomized in a double-blind, placebo-controlled study of single-dose midazolam for efficacy and safety in producing anxiolysis of short duration. A subpopulation of patients was evaluated prospectively in a nonrandomized arm of the study. Data on vital signs, anxiety, adverse events, and overall satisfaction were collected and compared using analysis of covariance model. RESULTS: Forty-four patients were randomized and 31 patients were enrolled in the prospective arm. Socioeconomic and surgical characteristics were similar among the groups. At 60 minutes, there was a clinically and statistically significant reduction in anxiety and alertness in both randomized and prospective arms. There were no major adverse events. Patients in all 3 groups were equally satisfied with their experience. LIMITATIONS: Few patients with high perioperative anxiety were willing to participate in a randomized controlled trial of anxiolytic medication. CONCLUSIONS:Midazolam is safe and efficacious in perioperative anxiolysis for healthy patients undergoing outpatient Mohs micrographic surgery. Midazolam offers the benefits of amnesia, reduced alertness, and reduced blood pressure with no clinically significant adverse effects. Copyright Â
Authors: Mark Biro; InYoung Kim; Andrea Huynh; Pingfu Fu; Margaret Mann; Daniel L Popkin Journal: J Am Acad Dermatol Date: 2019-06-01 Impact factor: 11.527