Double-blind comparison of alizapride, droperidol and ondansetron in the treatment of post-operative nausea

Abstract

To compare the efficacy in the treatment of post-operative nausea and/or vomiting (PONV), 75 patients undergoing gynaecological procedures under general anaesthesia using N2O/enflurane who suffered from PONV in the first hour after surgery were randomly allocated to three groups containing 25 patients each to receive either alizapride 100 mg, droperidol 1 mg or ondansetron 8 mg (i.v.). Patients expressed the severity of their nausea on a Visual Analogue Scale (VAS) ranging from 0 (none) to 10 (as bad as possible). Vomiting was recorded as present or absent, and the number of emetic events was noted. Data were recorded until rescue medication was given or until 4 h after the administration of the study drug. There were no significant differences between the three groups in the average VAS scores and the presence of vomiting at the time of entry into the study. Fifteen and 30 min after the administration of the study drug, VAS decreased notably in all groups. This decreases was similar and statistically significant within each group. However, comparison between the three groups showed no statistically significant differences. There was no statistically significant difference between the three groups in the number of patients receiving rescue medication, the number of emetic events and the time from administration of the study drug until rescue medication was given. It is concluded that alizapride 100 mg, droperidol 1 mg and ondansetron 8 mg intravenously are equally effective in the treatment of PONV after gynaecological procedures and that the newer drugs alizapride and ondansetron offer no advantage over droperidol.

Eficácia do ondansetron e da alizaprida na prevenção de náusea e vômito em laparoscopia ginecológica

“…Our results have shown no statistically significant differences between alizapride and ondansetron. Similar results were found in non laparoscopic gynecological surgeries were higher ondansetron (8 mg) and alizapride (100 mg) doses were used 23 . Alizapride (50 mg, 100 mg and 200 mg) was compared to placebo in preventing nausea and vomiting in ambulatory patients.…”

“…Pelos nossos resultados, pudemos observar que não houve diferenças estatisticamente significativas entre a alizaprida e o ondansetron. Resultados similares aos nossos foram observados em cirurgias ginecológicas não laparoscópicas nas quais foram utilizadas doses superiores de ondansetron (8 mg) e de alizaprida (100 mg) 23 . Em pacientes ambulatoriais, comparou-se a alizaprida com o placebo, quanto à efetividade em prevenir náusea e vômi-to.…”

Clinically significant changes in nausea as measured on a visual analog scale

“…The visual analog scale has been used to apply an objective measurement to subjective perceptions. [1][2][3][4][5][6][7][8][9][10] Although the visual analog scale has not been rigorously validated in the measurement for nausea, 2 investigators have demonstrated good correlation with verbal categorical measures of nausea in cancer and postoperative patients and support its use in clinical assessment. 5,6 Psychologists have used the visual analog scale for many years to measure subjective experiences such as mood and affect.…”

“…In the medical literature, it has been applied to the evaluation of a variety of symptoms, including pain, asthma severity, abdominal pain, and nausea. [1][2][3][4][5][6][7][8][9][10] It is simple to administer and is particularly useful for repeated measures in the same individual and for quantitative comparisons between groups of patients.…”

Ondansetrona oral na prevenção de náuseas e vômitos pós-operatórios

“…Durante anos, NVPO foram considerados efeitos inerentes à aplicação de anestésicos ou , bem como diversos agentes farmacoló-gicos como os fenotiazínicos proclorperazina [20][21][22] , prometazina [23][24][25] e perfenazina 26,27 ; os butirofenônicos haloperidol [28][29][30][31] e droperidol 25,[32][33][34][35][36][37][38][39] ; os anti-histamínicos difenidramina (dimenidrato) 40,41 ; hidroxizina 42,43 e ciclizina 4447 ; dentre os anticolinérgicos, a escopolamina 23,4850 ; os benzamídicos como a metoclopramida 33,37,[51][52][53][54][55][56][57] e domperidona 33,37,[58][59][60][61] ; a alizaprida [62][63][64][65] ; os corticosteróides 33,[66]…”