Abstract

Introduction: Urologists perform approximately 500.000 prostate biopsies per year in United States of

America. Currently there is no universally agreed standard of analgesia. Several studies evaluating the

tolerance of transrectal ultrasound (TRUS) guided biopsies showed that moderate to severe pain was

associated with the procedure. Patients may not return for repeat biopsies due to unpleasant experience with

prior biopsies. Large number of patients perceives the procedure painful with major psychological trauma.

Midazolam is used for gastrointestinal endoscopies because of its sedative and amnestic effects. To this end,

we evaluated the feasibility of midazolam and retrograde amnesia effect in patients undergoing transrectal

prostate biopsy.

Materials and Methods: A total of 52 patients undergoing TRUS-guided prostate biopsy were enrolled into

the study. Indications for biopsy were increased prostate specific antigen (PSA) or abnormal digital rectal

examination of the prostate. Patients were given midazolam as a bolus injection (70 mcg/kg, maximum total

dosage: 5 mg) before the biopsy procedure. All patients were examined in left lateral decubitus position and

TRUS biopsies were performed with a 7 MHz probe. Four core biopsies were obtained from the each lobe of

the prostate. After completion of biopsy, flumazenil (0.5 mg IV) was used to reverse the effects of midazolam.

All patients were placed on oxygen saturation monitorization during the procedure. The degree of sedation,

degree of pain, side effects and retrograde amnesia were evaluated with a validated questionnaire by the

surgeon and patient. A visual analog scale (VAS) was used to asses the pain score and Ramsey sedation score

was used to asses the sedation score. The Ramsey sedation scale scores between 2 and 4 were accepted as

satisfactory degree of sedation.

Results: After injection of midazolam, sedation was achieved in all patients in a short period of time.

Ninety-six percent of patients exhibited procedural amnesia, characterized by an inability to recall neither the

initial probe insertion nor the biopsy procedure. Only two patients remembered some parts of the procedure.

Forty four patients (%85) were willing to undergo re-biopsy if needed. These patients stated that they will

undergo a second biopsy only under the same conditions. Eight patients (%15) refused to undergo any further

diagnostic test or examination. The mean pain score of patients was 1.96±0.69. The Ramsey sedation scale

scores ranged between 2 and 4 in all patients. Nausea and vomiting due to midazolam were not observed in our

study, and we did not see any complication related to midazolam usage.

Conclusion: In this study we found high satisfaction rates, lower pain scores and lower anxiety in patients

undergoing TRUS guided biopsies due to sedative and amnestic effects of midazolam. This resulted in higher

acceptability of a repeat biopsy procedure, if indicated. Besides its sedative properties, midazolam can be used

as an effective agent during TRUS-guided prostate biopsies due to its procedural amnesia effect, which results

in minimal psychological trauma to patients.