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Jones S, Strobl R, Crosby D, Burkard JF, Maye J, Pellegrini JE. The effect of transdermal scopolamine on the incidence and severity of postoperative nausea and vomiting in a group of high-risk patients given prophylactic intravenous ondansetron

Naval Medical Center San Diego, California, USA.
AANA journal 05/2006; 74(2):127-32.
Source: PubMed

ABSTRACT Specific risk factors place patients at greater risk for postoperative nausea and vomiting (PONV). Routinely, these patients are treated prophylactically with intravenous (IV) ondansetron or transdermal (TD) scopolamine. No study has examined what effect using a combination of these prophylactic treatments would have on the incidence of PONV in a group of high-risk patients. A total of 56 patients at high risk for PONV were treated prophylactically with IV ondansetron and randomized to receive a TD scopolamine patch or placebo. Demographics, incidence, and severity of PONV and side effects and antiemetic requirements were measured. Nausea was measured using a 0 to 10 verbal numeric rating scale. Descriptive and inferential statistics were used for analysis. No difference in demographics or the incidence of side effects was noted between groups. Patients in the scopolamine group had a lower incidence of PONV (P = .043), longer time to first reported nausea (P = .044), longer time to first episode of emesis (P = .031), and decreased supplemental antiemetic requirements (P = .016) compared with the placebo group. Based on this study, we recommend using a combination of TD scopolamine and IV ondansetron to prevent PONV in patients identified as high risk for PONV.

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Available from: Joseph Pellegrini, Aug 27, 2015
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    • "Multiple clinical trials have proven the safety and clinical efficacy of the TDS in treatment of PONV in various patient groups when used as a single drug or in combination with other drugs. TDS may be an effective method of PONV prophylaxis when applied within 2 h prior to surgery and anesthesia (Kotelko et al., 1989; Reinhart et al., 1994; Jones et al., 2006; White et al., 2007; Gan et al., 2009; Sah et al., 2009; Lee et al., 2010a,b; Green et al., 2012). This can be explained by the fast release and absorption of the loading dose in the inner layer of the patch. "
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    ABSTRACT: Postoperative nausea and vomiting (PONV) is one of the most common and undesirable complaints recorded in as many as 70-80% of high-risk surgical patients. The current prophylactic therapy recommendations for PONV management stated in the Society of Ambulatory Anesthesia (SAMBA) guidelines should start with monotherapy and patients at moderate to high risk, a combination of antiemetic medication should be considered. Consequently, if rescue medication is required, the antiemetic drug chosen should be from a different therapeutic class and administration mode than the drug used for prophylaxis. The guidelines restrict the use of dexamethasone, transdermal scopolamine, aprepitant, and palonosetron as rescue medication 6 h after surgery. In an effort to find a safer and reliable therapy for PONV, new drugs with antiemetic properties and minimal side effects are needed, and scopolamine may be considered an effective alternative. Scopolamine is a belladonna alkaloid, α-(hydroxymethyl) benzene acetic acid 9-methyl-3-oxa-9-azatricyclo non-7-yl ester, acting as a non-selective muscarinic antagonist and producing both peripheral antimuscarinic and central sedative, antiemetic, and amnestic effects. The empirical formula is C17H21NO4 and its structural formula is a tertiary amine L-(2)-scopolamine (tropic acid ester with scopine; MW = 303.4). Scopolamine became the first drug commercially available as a transdermal therapeutic system used for extended continuous drug delivery during 72 h. Clinical trials with transdermal scopolamine have consistently demonstrated its safety and efficacy in PONV. Thus, scopolamine is a promising candidate for the management of PONV in adults as a first line monotherapy or in combination with other drugs. In addition, transdermal scopolamine might be helpful in preventing postoperative discharge nausea and vomiting owing to its long-lasting clinical effects.
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    ABSTRACT: Postoperative nausea and vomiting (PONV) are common complications after ambulatory surgery. We sought to determine whether the use of transdermal scopolamine (TDS) in combination with IV ondansetron (OND) is more effective than one alone for reducing PONV in outpatient settings. In a randomized, double blind, multicenter trial, 620 at-risk female patients undergoing outpatient laparoscopic or breast augmentation surgery received either an active TDS patch or a similar appearing sham 2 h before entering the operating room. All patients received IV OND (4 mg) 2-5 min before induction of anesthesia followed by a general anesthetic regimen. Complete antiemetic response, defined as no vomiting/retching or rescue medication use, was measured through 24 h and 48 h after surgery. The proportion of patients with vomiting/retching, nausea, or use of rescue medication, the time from the end of surgery to the first episode of these events and the time to discharge from the hospital/surgery center, as well as the number and severity of vomiting/retching and nausea episodes, and patient satisfaction with antiemetic therapy were also collected. The combination of TDS + OND statistically significantly reduced nausea and vomiting/retching compared with OND alone 24 h after surgery but not at 48 h. The proportion of patients who did not experience vomiting/retching and did not use rescue medication was 48% for TDS + OND and 39% for OND alone (P < 0.02). Total response (no nausea, no vomiting/retching, and no use of rescue medication) was also statistically higher for the TDS + OND group compared with the OND-only group (35% vs 25%, P < 0.01). The time to first nausea, vomiting/retching, or rescue episode was statistically significantly longer for the TDS + OND group compared with the OND-only group (P < 0.05). The cumulative overall incidence of adverse events was lower in the TDS + OND group compared with the OND group (36.7% vs 49%, P < 0.01). TDS + OND reduces PONV compared with OND alone. This is achieved with a reduction in adverse events.
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