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Intradermal thumbtack needle buried Neiguan (P6) point for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Postoperative nausea and vomiting (PONV) is among the most common adverse reactions following anaesthesia and surgery. Recent clinical studies have reported that the average incidence is about 30%, while in patients specifically undergoing neurosurgery, the incidence can be as great as 73%. Studies also suggest that its occurrence increases the risk of intracranial haematoma and haemorrhage. The objective of this study is to evaluate the effectiveness of intradermal thumbtack needle buried Neiguan (pericardium 6 (P6)) point therapy in the prevention of PONV in patients undergoing craniotomy under general anaesthesia. METHODS AND ANALYSIS:This is a single-centre, three-arm, randomised controlled trial. 180 participants are randomly assigned to either an acupuncture, intradermal thumbtack needle or control group in a 1:1:1 ratio. The P6 of the acupuncture group is punctured at both sides perpendicularly to a depth of 20?mm. Needles are retained for 30?min and stimulated every 10?min to maintain the de qi. The therapy includes two treatments; the acupuncture is administered immediately after and 24?hours after surgery. For the intradermal thumbtack needle group, the intradermal thumbtack needle is quickly inserted into the skin and embedded at P6 acupoints bilaterally. Patients and their families are asked to press the needlepoint with the onset of nausea, vomiting, bloating, pain and other reported discomforts. The needle is replaced after 24?hours. The therapy is administered immediately after and 24?hours after surgery. For the control group, no intervention is carried out. The incidence of PONV within 48?hours after craniotomy across the three groups is observed. Other observations include: (1) assessment of nausea score (severity of nausea) and pain score (visual analogue scale) 0-2, 2-6, 6-24 and 24-48?hours after craniotomy under general anaesthesia; (2) assessment of total rescue antiemetic dosage 0-48?hours after craniotomy under general anaesthesia; (3) length of hospital stay and (4) patient satisfaction score with PONV management. We will perform all statistical analysis following the intention-to-treat principle. ETHICS AND DISSEMINATION:Ethics approval has been granted by the Bioethics Subcommittee of the West China Hospital, Sichuan University: the approval number is 2018 (number 231). Results will be expected to be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ChiCTR1800017173.

SUBMITTER: Lv JQ

PROVIDER: S-EPMC6924804 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Postoperative nausea and vomiting (PONV) are common complications following surgery and anaesthesia. Drugs to prevent PONV are only partially effective. An alternative approach is to stimulate the P6 acupoint on the wrist. This is an update of a Cochrane review first published in 2004. OBJECTIVES:To determine the efficacy and safety of P6 acupoint stimulation in preventing PONV. SEARCH STRATEGY:We searched CENTRAL (The Cochrane Library, Issue 3, 2008), MEDLINE (January 1966 to September 2008), EMBASE (January 1988 to September 2008), ISI Web of Science (January 1965 to September 2008), the National Library of Medicine publication list of acupuncture studies, and reference lists of articles. SELECTION CRITERIA:All randomized trials of techniques that stimulated the P6 acupoint compared with sham treatment or drug therapy for the prevention of PONV. Interventions used in these trials included acupuncture, electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure in patients undergoing surgery. Primary outcomes were the risks of nausea and vomiting. Secondary outcomes were the need for rescue antiemetic therapy and adverse effects. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trial quality and extracted the data. We collected adverse effect information from the trials. We used a random-effects model and reported relative risk (RR) with associated 95% confidence intervals (95% CI). MAIN RESULTS:We included 40 trials involving 4858 participants; four trials reported adequate allocation concealment. Twelve trials did not report all outcomes. Compared with sham treatment P6 acupoint stimulation significantly reduced: nausea (RR 0.71, 95% CI 0.61 to 0.83); vomiting (RR 0.70, 95% CI 0.59 to 0.83), and the need for rescue antiemetics (RR 0.69, 95% CI 0.57 to 0.83). Heterogeneity among trials was moderate. There was no clear difference in the effectiveness of P6 acupoint stimulation for adults and children; or for invasive and noninvasive acupoint stimulation. There was no evidence of difference between P6 acupoint stimulation and antiemetic drugs in the risk of nausea (RR 0.82, 95% CI 0.60 to 1.13), vomiting (RR 1.01, 95% CI 0.77 to 1.31), or the need for rescue antiemetics (RR 0.82, 95% CI 0.59 to 1.13). The side effects associated with P6 acupoint stimulation were minor. There was no evidence of publication bias from contour-enhanced funnel plots. AUTHORS' CONCLUSIONS:P6 acupoint stimulation prevented PONV. There was no reliable evidence for differences in risks of postoperative nausea or vomiting after P6 acupoint stimulation compared to antiemetic drugs.

Project description:PurposeTo assess the impact of a multimodal antiemetic protocol on postoperative nausea and vomiting (PONV) after Le Fort I osteotomy.Materials and methodsConsecutive patients undergoing Le Fort I osteotomy with or without additional procedures at a single academic institution were recruited as the intervention cohort for an institutional review board-approved prospective clinical trial with a retrospective comparison group. The intervention cohort was managed with a multimodal antiemetic protocol, including total intravenous anesthesia; prophylactic ondansetron, steroids, scopolamine, and droperidol; gastric decompression at surgery end; opioid-sparing analgesia; avoidance of morphine and codeine; prokinetic erythromycin; and fluids at a minimum of 25 mL/kg. The comparison group consisted of consecutive patients from a larger study who underwent similar surgical procedures before protocol implementation. Data, including occurrence of PONV, were extracted from medical records. Data were analyzed in bivariate fashion with the Fisher exact and Wilcoxon rank-sum tests. Logistic regression was used to compare the likelihood of nausea and vomiting in the 2 cohorts after controlling for demographic and surgical characteristics. A P value less than .05 was considered significant.ResultsThe intervention (n = 93) and comparison (n = 137) groups were similar in gender (58% and 65% female patients; P = .29), race (72% and 71% Caucasian; P = .85), age (median, 19 and 20 years old; P = .75), proportion of patients with known risk factors for PONV (P = .34), percentage undergoing bimaxillary surgery (60% for the 2 groups), and percentage for whom surgery time was longer than 180 minutes (63% and 59%; P = .51). Prevalence of postoperative nausea was significantly lower in the intervention group than in the comparison group (24% vs 70%; P < .0001). Prevalence of postoperative vomiting was likewise significantly lower in the intervention group (11% vs 28%; P = .0013). The likelihood that patients in the comparison group would develop nausea was 8.9 and that for vomiting was 3.7 times higher than in the intervention group.ConclusionThis multimodal protocol was associated with substantially decreased prevalence of PONV in patients undergoing Le Fort I osteotomy.

Project description:Background: There is uncertainty about the effect of antiemetic drugs (AED) for the prophylaxis of postoperative nausea and vomiting (PONV) after craniotomy. In this study, we assessed the effectiveness and safety of AED for PONV. Methods and Findings: We searched online databases including the Cochrane Library, PubMed, Wiley, Elsevier Science Direct, Ovid LWW, and Springer for publications from 1985 to June 2018. Adults undergoing craniotomy with the prophylactic use of at least one AED were included. The primary outcomes were the incidence of postoperative nausea (PON) and postoperative vomiting (POV) during the first and second day. A total of 1,433 participants from 17 clinical trials were enrolled in this Network Meta-Analysis (NMA). Compared to placebo, ramosetron was the most effective treatment for PON 24 h after surgery (OR = 0.063, 95% Crl: 0.006-0.45), with a 69.2% probability. On the other hand, for POV, droperidol was the best treatment during the first 2 h with a 71.1% probability (OR = 0.029, 95% Crl: 0.003-0.25); while fosaprepitant was the most effective treatment at 0-24 h (OR = 0.027, 95% Crl: 0.007-0.094; 66.9% probability) and 0-48 h (OR = 0.036, 95% Crl: 0.006-0.18; 56.6% probability). Besides, ramosetron showed a significantly higher incidence of complete response (OR = 29. 95% Crl: 1.4-6.5e + 02), as well as lower requirement for rescue AED (OR = 0.022, 95% Crl: 0.001-0.2). Granisetron was associated with the lowest incidence of headache and excessive sedation. Conclusions: Compared with placebo, ramosetron appears to be the best prophylactic treatment for PON 24 h after craniotomy, with higher complete responses. Fosaprepitant appears to be the most effective prophylaxis option for POV on the first 0-24 and 0-48 h. Both may be better applied in combination with perioperative dexamethasone. These findings may guide clinicians to provide improved pharmacological prophylaxis for PONV after craniotomy with fewer adverse effects.

Project description:INTRODUCTION:Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24?h after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone, and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia. METHODS:The research protocol was approved by the institutional review board and 40 subjects were provided written informed consent. At induction of anesthesia, a triple therapy of palonosetron 0.075?mg IV, dexamethasone 10?mg IV, and promethazine 25?mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit or post anesthesia care unit as clinically indicated. Ondansetron 4?mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24?h for 5?days via direct interview and/or medical charts review. RESULTS:The overall incidence of PONV during the first 24?h after surgery was 30% (n?=?12). The incidence of nausea and emesis 24?h after surgery was 30% (n?=?12) and 7.5% (n?=?3), respectively. The mean time to first emetic episode, first rescue, and first significant nausea was 31.3 (±33.6), 15.1 (±25.8), and 21.1 (±25.4) hours, respectively. The overall incidence of nausea and vomiting after 24-120?h period after surgery was 30% (n?=?12). The percentage of subjects without emesis episodes over 24-120?h postoperatively was 70% (n?=?28). No subjects presented a prolonged QTc interval ?500?ms before and/or after surgery. CONCLUSION:Our data demonstrated that this triple therapy regimen may be an adequate alternative regimen for the treatment of PONV in patients undergoing neurological surgery under general anesthesia. More studies with a control group should be performed to demonstrate the efficacy of this regimen and that palonosetron is a low risk for QTc prolongation. CLINICALTRIALSGOV IDENTIFIER:NCT02635828 (https://clinicaltrials.gov/show/NCT02635828).

Project description:Postoperative nausea and vomiting (PONV) is one of the most common adverse outcomes after strabismus surgery. The primary outcome of this prospective, randomized, double-blind study was to compare the incidences of nausea or vomiting, and patient satisfaction of ondansetron and ramosetron after strabismus surgery under general anesthesia. The secondary outcome was to investigate whether the number of involved extraocular muscles (EOMs) in strabismus surgery was related to PONV.One hundred and five patients (aged 18-60 years) undergoing strabismus surgery were allocated randomly to one of the three groups: placebo, ondansetron, or ramosetron. Patients received 2 ml placebo, 4 mg ondansetron, or 0.3 mg ramosetron at the end of surgery. Each of the three groups was subdivided into two subgroups according to the number of EOMs involved in the surgery: subgroup S, single-muscle correction; subgroup M, multiple-muscle correction. The incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as primary outcome. With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as seconadary outcome.The incidence of nausea was significantly lower in the ramosetron group at 2 h (9.4 %) than in the placebo (45.2 %) and ondansetron (34.7 %) groups (P < 0.05). The incidence of nausea was also significantly lower in the ramosetron group at 24 h than in the other groups (P < 0.05). Patients in the ramosetron group were more satisfied at 2 h (8.11 ± 0.98) and 24 h (8.50 ± 0.67) after surgery than those in the other groups (P < 0.05). With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, there were no significant differences in either the incidence of nausea or patient satisfaction.Ramosetron has superior antiemetic activity to ondansetron in adult strabismus surgery patients. The number of EOMs involved in strabismus surgery was not related to the incidence of PONV.Clinical Research Information Service (CRiS) Identifier: KCT0000688 . Date of registration: 27 February 2013.

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Intradermal thumbtack needle buried Neiguan (P6) point for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: study protocol for a randomised controlled trial.

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