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Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study.

ABSTRACT: Postoperative nausea and vomiting after general anesthesia is not only an unpleasant problem affecting 20-30% of surgical patients but may also lead to severe postoperative complications. There is a particularly high incidence of postoperative nausea and vomiting following thyroidectomy. Dexamethasone has been described as highly effective against chemotherapy-induced nausea and vomiting and has been proposed as a first-line method of postoperative nausea and vomiting prophylaxis. Despite this possible beneficial effect, the prophylactic administration of dexamethasone before surgery to prevent or ameliorate postoperative nausea and vomiting has not been established. A bilateral superficial cervical plexus block during thyroid surgery under general anesthesia significantly reduces pain. Of even greater clinical importance, this block prevents the need for postoperative opioids. Therefore, patients undergoing thyroidectomy and a bilateral superficial cervical plexus block are an ideal group to investigate the efficacy of dexamethasone for postoperative nausea and vomiting. These patients have a high incidence of postoperative nausea and vomiting and do not require opioids. They have no abdominal surgery, which can cause nausea and vomiting via a paralytic ileus. Combined with the highly standardized anesthesia protocol in use at our institution, this setting allows all known biases to be controlled.We will perform a parallel two-arm, randomized (1:1), double-blind, placebo-controlled, single-center trial. Adults (?18 years) scheduled for primary partial or total thyroidectomy because of a benign disease will be eligible for inclusion. The participants will be randomized to receive a single, intravenous preoperative dose of either 8 mg of dexamethasone in 2 ml saline (treatment group) or saline alone (placebo group). All the patients will receive a bilateral superficial cervical plexus block and standardized anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 152 patients will be recruited, providing 80% power to detect a 50% reduction in the incidence of postoperative nausea and vomiting. Any patients who require opioid treatment will be excluded from the per-protocol analysis.In the present protocol, we reduced bias to the greatest extent possible. Thus, we expect to definitively clarify the efficacy of dexamethasone for postoperative nausea and vomiting prophylaxis.http://www.clinicaltrials.gov: NCT01189292.

SUBMITTER: Tarantino I

PROVIDER: S-EPMC3847691 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study.

Tarantino Ignazio I Beutner Ulrich U Kolb Walter W Müller Sascha A SA Lüthi Cornelia C Lüthi Andreas A Schmied Bruno M BM Clerici Thomas T Warschkow Rene R

BMC anesthesiology 20130909 1

<h4>Background</h4>Postoperative nausea and vomiting after general anesthesia is not only an unpleasant problem affecting 20-30% of surgical patients but may also lead to severe postoperative complications. There is a particularly high incidence of postoperative nausea and vomiting following thyroidectomy. Dexamethasone has been described as highly effective against chemotherapy-induced nausea and vomiting and has been proposed as a first-line method of postoperative nausea and vomiting prophyla ...[more]

PMID: 24015953

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Project description:ObjectiveTo determine the effectiveness of pharmacologic interventions for preventing postoperative nausea and vomiting (PONV) in patients undergoing thyroidectomy.DesignSystematic review and network meta-analysis (NMA).Data sourcesMEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Google Scholar.Eligibility criteria, participants, and interventionsRandomized clinical trials that investigated the efficacy of pharmacologic interventions in preventing PONV in patients undergoing thyroidectomy were included. The primary endpoints were the incidences of postoperative nausea and vomiting (PONV), postoperative nausea (PON), postoperative vomiting (POV), use of rescue antiemetics, and incidence of complete response in the overall postoperative phases. The secondary endpoints were the same parameters assessed in the early, middle, and late postoperative phases. The surface under the cumulative ranking curve (SUCRA) values and rankograms were used to present the hierarchy of pharmacologic interventions.ResultsTwenty-six studies (n = 3,467 patients) that investigated 17 different pharmacologic interventions were included. According to the SUCRA values, the incidence of PONV among the overall postoperative phases was lowest with propofol alone (16.1%), followed by palonosetron (27.5%), and with tropisetron (28.7%). The incidence of PON among the overall postoperative phases was lowest with propofol alone (11.8%), followed by tropisetron and propofol combination (14%), and ramosetron and dexamethasone combination (18.0%). The incidence of POV among the overall postoperative phases was lowest with tropisetron and propofol combination (2.2%), followed by ramosetron and dexamethasone combination (23.2%), and tropisetron alone (37.3%). The least usage of rescue antiemetics among the overall postoperative phases and the highest complete response was observed with tropisetron and propofol combination (3.9% and 96.6%, respectively).ConclusionPropofol and tropisetron alone and in combination, and the ramosetron and dexamethasone combination effectively prevented PONV, PON, POV in patients undergoing thyroidectomy, with some heterogeneity observed in this NMA of full-text reports. Their use minimized the need for rescue antiemetics and enhanced the complete response.Trial registration numberCRD42018100002.

Project description:BackgroundWe carried out a systematic review and meta-analysis to evaluate the impact of prophylactic dexamethasone on post-operative nausea and vomiting (PONV), post-operative pain, and complications in patients undergoing thyroidectomy.MethodsWe searched Pubmed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) that evaluated the prophylactic effect of dexamethasone versus placebo with or without other antiemetics for PONV in patients undergoing thyroidectomy. Meta-analyses were performed using RevMan 5.0 software.ResultsThirteen RCTs that considered high quality evidence including 2,180 patients were analyzed. The meta-analysis demonstrated a significant decrease in the incidence of PONV (RR 0.52, 95% CI 0.43 to 0.63, P < 0.00001), the need for rescue anti-emetics (RR 0.42, 95% CI 0.30 to 0.57, P<0.00001), post-operative pain scores (WMD -1.17, 95% CI -1.91 to -0.44, P = 0.002), and the need for rescue analgesics (RR 0.65, 95% CI 0.50-0.83, P = 0.0008) in patients receiving dexamethasone compared to placebo, with or without concomitant antiemetics. Dexamethasone 8-10mg had a significantly greater effect for reducing the incidence of PONV than dexamethasone 1.25-5mg. Dexamethasone was as effective as other anti-emetics for reducing PONV (RR 1.25, 95% CI 0.86-1.81, P = 0.24). A significantly higher level of blood glucose during the immediate post-operative period in patients receiving dexamethasone compared to controls was the only adverse event.ConclusionsProphylactic dexamethasone 8-10mg administered intravenously before induction of anesthesia should be recommended as a safe and effective strategy for reducing the incidence of PONV, the need for rescue anti-emetics, post-operative pain, and the need for rescue analgesia in thyroidectomy patients, except those that are pregnant, have diabetes mellitus, hyperglycemia, or contraindications for dexamethasone. More high quality trials are warranted to define the benefits and risks of prophylactic dexamethasone in potential patients with a high risk for PONV.

Dataset Information

Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study.

Publications

Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study.

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