Comparison of propofol, droperidol, and metoclopramide for prophylaxis of postoperative nausea and vomiting after breast cancer surgery: a prospective, randomized, double-blind, placebo-controlled study in Japanese patients.
BACKGROUND
Breast cancer surgery performed with the patient under general anesthesia has been associated with a relatively high incidence of postoperative nausea and vomiting (PONV). Between 60% and 80% of patients who undergo mastectomy (with axillary dissection) experience PONV. We previously reported that propofol at a subhypnotic dose of 0.5 mg/kg was more effective than placebo in preventing PONV in women who undergo mastectomy.


OBJECTIVE
The purpose of this study was to compare the efficacy of a subhypnotic dose of propofol with the conventional antiemetics droperidol and metoclopramide for the prophylaxis of PONV after breast cancer surgery in Japanese patients.


METHODS
In this prospective, randomized, double-blind, placebo-controlled study, Japanese women were randomized to 1 of 4 groups to receive IV administration of propofol 0.5 mg/kg, droperidol 20 microg/kg, metoclopramide 0.2 mg/kg, or placebo (isotonic saline) immediately after skin suture. A standard general anesthetic technique, including sevoflurane and air in oxygen, was used. All episodes of PONV during the first 24 hours after anesthesia administration were recorded by an investigator who was blinded to treatment assignment. The investigator questioned the patients as to whether they experienced extrapyramidal symptoms. To maintain the integrity of the study results, none of the patients received preanesthetic medication.


RESULTS
A total of 100 women (mean [SD] age, 52 [7] years; height, 154 [6] cm; weight, 54 [7] kg) were included in the study. Each study group comprised 25 patients. There were no significant differences between treatment groups with regard to patient demographics, surgery type, or awakening time. The prevalences of PONV 0 to 24 hours after anesthesia were 28% with propofol (P = 0.005), 32% with droperidol (P = 0.011), and 60% with metoclopramide (P = NS), compared with placebo (68%). No significant difference in the prevalence of PONV was found between patients receiving propofol and those receiving droperidol, and propofol and droperidol were associated with significantly lower prevalences of PONV compared with metoclopramide (P = 0.022 and P = 0.043, respectively). Extrapyramidal symptoms were not reported in any of the groups.


CONCLUSIONS
The prevalences of PONV were not significantly different between propofol 0.5 mg/kg and droperidol 20 microg/kg 0 to 24 hours after anesthesia in this small, select group of Japanese women who underwent breast cancer surgery. The prevalences of PONV were significantly lower with propofol and droperidol compared with metoclopramide 0.2 mg/kg and placebo.
Fujii
Yoshitaka
Y
First Department of Anesthesiology, Toho University School of Medicine, Tokyo, Japan. yfujii@med.toho-u.ac.jp
Itakura
Michiyo
M
D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D044466:Asian People / Q000706:statistics & numerical data; D001943:Breast Neoplasms / Q000208:ethnology / Q000601:surgery*; D004311:Double-Blind Method; D004329:Droperidol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007564:Japan / Q000453:epidemiology; D015411:Mastectomy, Modified Radical / Q000379:methods; D015412:Mastectomy, Segmental / Q000379:methods; D008787:Metoclopramide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D020250:Postoperative Nausea and Vomiting / Q000517:prevention & control*; D015995:Prevalence; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects
D000932:Antiemetics; D008787:Metoclopramide; D004329:Droperidol; D015742:Propofol