Haloperidol dose combined with dexamethasone for PONV prophylaxis in high-risk patients undergoing gynecological laparoscopic surgery: a prospective, randomized, double-blind, dose-response and placebo-controlled study

Abstract

BackgroundLow-dose haloperidol is known to be effective for the prevention of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify which dose of haloperidol 1mg or 2mg could be combined with dexamethasone without adverse effects in high-risk patients undergoing gynecological laparoscopic surgery.MethodsFemale adults (n = 150) with three established PONV risk factors based on Apfel’s score were randomized into one of three study groups. At the end of anesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone 5 mg during the induction of anesthesia. The overall early (0–2 h) and late (2–24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanesthesia care unit (PACU).ResultsThe total incidence of PONV over 24 h was significantly lower in groups H1 (29 %) and H2 (24 %) than in group H0 (54 %; P = 0.003), but there was no significant difference between groups H1 and H2. In the PACU, group H2 had a higher sedation score than groups H1 and H0 (P < 0.001).ConclusionsFor high-risk PONV patients undergoing gynecological laparoscopic surgery, when used with dexamethasone, 1-mg haloperidol was equally effective as 2 mg in terms of preventing PONV with the less sedative effect.Trial RegistrationClinicalTrials.gov (NCT01639599).

Addition of haloperidol to ondansetron and dexamethasone to prevent postoperative nausea and vomiting in female smoking patients following laparoscopic surgery: A prospective, randomized, double-blind study

“…However, it is associated with risk of QTc prolongation, and it is advised to use haloperidol with caution for the prevention of PONV [30]. In the current research, haloperidol was administered at a dosage of 2 mg, and no cases of QTc prolongation or neurological syndrome were detected in group ODH, which is in accordance with previous studies [9,31] and suggests that the drugs used and their combinations were well tolerated and can be considered safe.…”

“…These drugs appear to be similar in efficacy when used as single agents, and to exert an additive effect when in combination [8,35]. Notably, it has been identified that a combination of two types of the drugs may exert additive effect [9][10][11], such as double prophylaxis with ondansetron and dexamethasone. Whether adding a third drug could exert greater benefit has remained uncertain.…”

“…As they affect different targets, their combination may exert greater function. A two-drug combination, such as a double prophylaxis with ondansetron and dexamethasone, has been demonstrated to be more effective than use of only one drug in preventing PONV [9][10][11]. However, limited studies have focused on triple prophylaxis for PONV [12,13], and to our knowledge, whether addition of haloperidol to ondansetron and dexamethasone may improve therapeutic efficacy has thus far remained unclear.…”

Haloperidol and Postoperative Nausea and Vomiting: A Systematic Review

“…The study by Chu et al (2008) noted two patients who experienced the EPS symptom of motor restlessness; Feng et al (2009) also noted two patients in their study experienced motor restlessness. In the study by Joo et al (2015), there were no extrapyramidal side symptoms (EPS) noted; however, in groups medicated with 2 mg of haloperidol there was increased sedation levels. Wang et al (2008) stated there were no adverse side effects of haloperidol noted.…”

“…The findings can be applied to similar population groups and the benefits were shown to be worth the harms and costs. Joo et al (2015) conducted a study (Appendix C-4) that evaluated at which dose haloperidol could be combined with dexamethasone to prevent PONV without adverse side effects in patients undergoing gynecological laparoscopic procedures. It was a clinical double-blind randomized trial.…”