A prospective controlled study to assess the antiemetic effect of midazolam following intragastric balloon insertion

Abstract

Background and Aims:Obesity is a chronic disease with considerable morbidity and mortality. The intragastric balloon appears attractive for a group of patients who do not respond to medical therapy and who are not surgical candidates. Postoperative nausea and vomiting (PONV) are distressing adverse effects for these patients. Midazolam has been used as an antiemetic, both as a preventive or rescue medication. The study aims at studying effect of combined use of ondansetron and midazolam to decrease the PONV following intragastric balloon insertion.Materials and Methods:The study was conducted on 54 patients presented for intragastric balloon insertion during the period between 1st of January 2012 and 31 December 2012. Patients were randomly allocated into two groups; Ondansetron group and ondansetron/midazolam group. Patients were assessed for the incidence of nausea and vomiting, nausea and vomiting score, degree of sedation and occurrence of adverse effects during the first 24 h after the operation.Results:Incidence of nausea and/or vomiting during the first 24 h postoperatively was 66% in the ondansetron group, while 34.5% among the ondansetron-midazolam group. There was significant reduction of nausea and/or vomiting in the second group. Degree of postoperative sedation was also significantly different between the two groups in the immediate postoperative period and 30min postoperatively.Conclusion:Use of midazolam combined with ondansetron provides significant reduction and therefore better outcome regarding nausea and vomiting following intragastric balloon insertion.

AGA Clinical Practice Guidelines on Intragastric Balloons in the Management of Obesity

“…The first study compared a therapeutic regimen of midazolam and ondansetron vs ondansetron alone for preventive treatment of nausea/vomiting and found that combination therapy of midazolam and ondansetron trended toward outperforming ondansetron alone (RR, 0.57; 95% CI, 0.32-1.02). 10 Further, early balloon removal rate was lower in the midazolam and ondansetron arm compared with the ondansetron-alone arm (0 of 29 and 3 of 28, respectively; RR, 0.14; 95% CI, 0.01-2.56). The second study compared mean vomiting incidence among alizapride, tropisetron, and tropisetron with droperidol, but due to limited availability of these agents in the United States, it was not applied to this recommendation.…”

Midazolam versus dexamethasone‐ondansetron in preventing post‐operative nausea‐vomiting in patients undergoing laparoscopic surgeries

“…In 2007, Lee et al found that 2 mg of midazolam was as good as 4 mg of ondansetron for PONV prophylaxis in female non‐smoking patients 15 . Most of the current literature, however, focuses on the effect of addition of midazolam to antiemetic agents like 5HT3 antagonists, dexamethasone and haloperidol 8,16,17 . Kim and co‐workers reported that midazolam provided better PONV prophylaxis than ondansetron and that the combination of ondansetron and midazolam was more effective in reducing PONV (33.3% vs 63.3% with ondansetron and 46.7% with midazolam) 5 .…”

“…Perioperative details in the two groups addition of midazolam to antiemetic agents like 5HT3 antagonists, dexamethasone and haloperidol. 8,16,17 Kim and co-workers reported that midazolam provided better PONV prophylaxis than ondansetron and that the combination of ondansetron and midazolam was more effective in reducing PONV (33.3% vs 63.3% with ondansetron and 46.7% with midazolam). 5 Similarly, Park and colleagues, in their study on 126 patients undergoing laparoscopic gynaecological surgeries, reported that incidence of complete response was around 70% with a combination of midazolam and ramosetron while it was 44% with ramosetron alone.…”

Short-term effects of intragastric balloon in association with conservative therapy on weight loss: a meta-analysis

“…Fortunately, the complications were all minor and most of them were self-healing reactions which would disappear after a few days. In the meaning time, some researches [ 29 – 31 ] were committed to improving these conditions by developing new balloons or new placement techniques as well as by associating with other treatment such as antiemetic. Although some serious complications such as gastric-intestinal perforation or intestinal obstruction were not reported in this review, it should be noted that there were some trials meeting these reactions [ 10 , 32 , 33 ].…”