The use of oral midazolam for perioperative anxiolysis of healthy patients undergoing Mohs surgery: conclusions from randomized controlled and prospective studies.
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.


CONCLUSIONS
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.
Division of Dermatology, Ohio State University, Columbus, OH, USA. larisa.ravitskiy@osumc.edu
Larisa
L
Ravitskiy
Pamela K
PK
Phillips
Randall K
RK
Roenigk
Amy L
AL
Weaver
Jill M
JM
Killian
Alyssa
A
Hoverson Schott
Clark C
CC
Otley
D000284:Administration, Oral; D000368:Aged; D000556:Ambulatory Surgical Procedures; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008874:Midazolam / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D015580:Mohs Surgery / Q000379:methods*; D017060:Patient Satisfaction; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000601:surgery
D014151:Anti-Anxiety Agents; D008874:Midazolam