A randomized double blind placebo controlled trial evaluating the use of droperidol as a routine premedication for endoscopic ultrasound

Introduction: Droperidol (DR) is a neuroleptic agent with antiemetic properties that produces mild sedation, reduced anxiety and a state of mental detachment and indifference to one's surroundings. It also enhances other sedative medications. Routine premedication with DR was recently shown to be safe and effective for optimizing sedation during ERCP. The purpose of this study was to determine if premedication with DR, comparing 2 standard dosages could provide the same benefit during endoscopic ultrasound (EUS). Methods: Sixty-nine consecutive patients undergoing routine upper EUS were randomly assigned to receive either 2.5mg or 5mg of DR or Placebo (PL)(2 cc of saline) by IV 15 minutes prior to the procedure. Following the EUS, the physician, nurse, and recovered patient scored various parameters of procedural sedation using an ordinal scale. The patient was called 24 hours post-EUS to assess for adverse effects of DR. Statistical analysis was performed using Fischer Exact Test, Mann-Whitney, and ANOVA. Results: Twenty-two patients received 2.5mg DR, 24 received 5mg DR, and 23 received PL. Four patients in the PL group were rescheduled due to combativeness. In comparing the 3 groups, there was no significant difference in age, race, sex, alcohol or prescription/illicit narcotic use, procedure time, recovery time, or change in vitals. However, 31% less midazolam (MZ) was used in both the 5mg(p = 0.01) and the 2.5mg(p=0.01) DR groups and 25% less meperidine (MP) was used in the 5mg DR group(p = 0.058) making medication costs similar in all groups. The following parameters were significant in the 5mg DR group compared to PL group: less retching during procedure(p = 0.006), less gagging at intubation(p = 0.047), decreased need for physical restraint(p = 0.02), improved patient cooperation (p=0.01), lower dose of MZ used (p = 0.01), improved physician(p = 0.0001) and nurse's (p = 0.048) impression of overall sedation. In the 2.5mg DR group the following parameters were significantly different compared to PL group: decreased need for restraint(p = 0.02), lower dose of MZ(p = 0.02), improved physician impression of sedation(p=0.001). There was no significant difference among the 3 groups for the patient's impression of sedation, recollection of procedure, scoring of pain and gagging during the procedure, post-procedure nausea, or dose of MP used during the procedure. No patients in any group required reversal of sedation. No adverse effects were noted. Summary: While the patients' impression of sedation did not vary, other parameters evaluated confirmed improved sedation. Also, 2.5mg of DR appears to improve sedation, but not as effectively as a 5mg dose. Conclusion: A 5mg dose of DR improved patient cooperation, decreased the need for physical restraint and improved overall physician and nurse satisfaction with sedation, without adverse effects to the patient, or increased recovery time or medication costs.