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.
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:INTRODUCTION:Postoperative nausea and vomiting (PONV) is among the most common distressing complications of surgery under anesthesia. Previous studies have demonstrated that patients who undergo craniotomy have incidences of nausea and vomiting as high as 50-70%. The main purpose of this pilot study is to assess the incidence of PONV by using two different prophylactic regimens in subjects undergoing a craniotomy. Thus, we designed this study to assess the efficacy and safety of triple therapy with the combination of dexamethasone, promethazine, and aprepitant versus ondansetron to reduce the incidence of PONV in patients undergoing craniotomy. MATERIALS AND METHODS:This is a prospective, single center, two-armed, randomized, double-dummy, double-blind, pilot study. Subjects were randomly assigned to one of the two treatment groups. Subjects received 40?mg of aprepitant pill (or matching placebo pill) 30-60?min before induction of anesthesia and 4?mg of ondansetron IV (or 2?ml of placebo saline solution) at induction of anesthesia. In addition, all subjects received 25?mg of promethazine IV and 10?mg of dexamethasone IV at induction of anesthesia. Assessments of PONV commenced for the first 24?h after surgery and were subsequently assessed for up to 5?days. RESULTS:The overall incidence of PONV during the first 24?h after surgery was 31.0% (n?=?15) in the aprepitant group and 36.2% (n?=?17) for the ondansetron group. The median times to first emetic and significant nausea episodes were 7.6 (2.9, 48.7) and 14.3 (4.4, 30.7) hours, respectively, for the aprepitant group and 6.0 (2.2, 29.5) and 9.6?(0.7, 35.2) hours, respectively, for the ondansetron group. There were no statistically significant differences between these groups. No adverse events directly related to study medications were found. CONCLUSION:This pilot study showed similar effectiveness when comparing the two PONV prophylaxis regimens. Our data showed that both treatments could be effective regimens to prevent PONV in patients undergoing craniotomy under general anesthesia. Future trials testing new PONV prophylaxis regimens in this surgical population should be performed to gain a better understanding of how to best provide prophylactic treatment.
Project description:Objective:Postoperative nausea and vomiting (PONV) is a common problem associated with general anaesthesia. The incidence can be as high as 80% in high-risk patients. Our primary objective was to compare the efficacy of the combination of dexamethasone-ondansetron and dexamethasone-aprepitant in patients undergoing laparoscopic surgery. Methods:Seventy 18 to 60 years old patients scheduled for laparoscopic surgery were included in the study. Sixty-seven patients completed the study. Patients in the dexamethasone-aprepitant group (group DA, n=35) received 40 mg of aprepitant orally 1-2 hours before the induction of anaesthesia and 2 mL saline intravenously (iv) within the last 30 minutes of surgery; patients in the dexamethasone-ondansetron group (group DO, n=35) received oral placebo identical to aprepitant 1-2 hours before the induction of anaesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patients received 8 mg dexamethasone iv after the induction of anaesthesia. The primary outcome was a complete response (no postoperative nausea, retching and vomiting and no need for rescue antiemetic); the secondary outcomes were the incidence of nausea, retching, vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Results:A complete response was not significantly different between the groups (group DO: 67%, DA: 69%) at 24 hours (p=0.93). The incidence of PONV and postoperative opioid consumption was similar between the groups. Conclusion:The study was designed to evaluate whether the combination of dexamethasone-aprepitant is better than the combination of dexamethasone-ondansetron regarding the complete response for PONV in patients undergoing laparoscopic surgery. The results however showed that dexamethasone-aprepitant has not improved the complete response for PONV compared to dexamethasone-ondansetron.
Project description:<h4>Background</h4>Acupuncture therapy for preventive and treatment of postoperative nausea and vomiting(PONV), a condition which commonly present after anaesthesia and surgery is a subject of growing interest.<h4>Objective</h4>This paper included a systematic review and meta-analysis on the effect of different type of acupuncture and acupoint selection in PONV prevention and treatment.<h4>Methods</h4>Randomised controlled trials(RCTs) comparing acupuncture with non-acupuncture treatment were identified from databases PubMed, Cochrane, EBSCO, Ovid, CNKI and Wanfangdata. Meta-analysis on eligible studies was performed using fixed-effects model with RevMan 5.2. Results were expressed as RR for dichotomous data, with 95%CI.<h4>Results</h4>Thirty RCTs, 1276 patients (intervention) and 1258 patients (control) were identified. Meta-analysis showed that PC6 acupuncture significantly reduced the number of cases of early vomiting (postoperative 0-6h) (RR=0.36, 95%CI 0.19,0.71; P=0.003) and nausea (postoperative 0-24h) (RR=0.25, 95%CI 0.10,0.61; P=0.002), but not early nausea (postoperative 0-6h) (RR=0.64, 95%CI 0.34,1.19; P=0.150) and vomiting (postoperative 0-24h) (RR=0.82, 95%CI 0.48,1.38; P=0.450). PC6 acupressure significantly reduced the number of cases of nausea (RR=0.71, 95%CI 0.57,0.87; P=0.001) and vomiting (RR=0.62, 95%CI 0.49,0.80; P=0.000) at postoperative 0-24h. PC6 electro-acupoint stimulation significantly reduced the number of cases of nausea (RR=0.49, 95%CI 0.38,0.63; P<0.000) and vomiting (RR=0.50, 95%CI 0.36,0.70; P<0.000) at postoperative 0-24h. Stimulation of PC6 with other acupoint(s) significantly reduced the number of cases of nausea and vomiting (RR=0.29, 95%CI 0.17,0.49; P<0.000) at postoperative 0-24h. Stimulation of other acupoint(s)(non PC6) also significantly reduced the number of cases of nausea and vomiting (RR=0.63, 95%CI 0.49,0.81; P=0.000) at postoperative 0-24h. However, the quality of study was generally low in studies of PC6 combined with other acupoint(s) and other acupoint(s). Details of blinding were not reported in most reports.<h4>Conclusions</h4>Besides PC6, PC6 combined with other acupoint(s) and other alternative acupoint(s) might be beneficial in prevention and treatment of PONV, the evidence justifies future high-quality studies.
Project description:INTRODUCTION:Postoperative nausea, retching and vomiting (PONV) remains one of the most common side effects of general anaesthesia, contributing significantly to patient dissatisfaction, cost and complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim to conduct a large, definitive randomised controlled trial of the efficacy and safety of peppermint-flavoured chewing gum to treat PONV in the postanaesthesia care unit (PACU). If chewing gum is shown to be as effective as ondansetron, this trial has the potential to significantly improve outcomes for tens of millions of surgical patients around the world each year. METHODS AND ANALYSIS:This is a prospective, multicentre, randomised controlled non-inferiority trial. 272 female patients aged ≥12 years having volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery will be randomised. Patients experiencing nausea, retching or vomiting in PACU will be randomised to 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration. ETHICS AND DISSEMINATION:The Chewy Trial has been approved by the Human Research Ethics Committees at all sites. Dissemination will be via international and national anaesthesia conferences, and publication in the peer-reviewed literature. TRIAL REGISTRATION NUMBER:ACTRN12618000429257; Pre-results.
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:BACKGROUND:Infratentorial craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). Enhanced Recovery After Surgery (ERAS) protocols have been shown in multiple surgical disciplines to improve outcomes, including reduced PONV. However, very few studies have described the application of ERAS to infratentorial craniotomy. The aim of this study was to examine whether our ERAS protocol for infratentorial craniotomy could improve PONV. METHODS:We implemented an evidence-based, multimodal ERAS protocol for patients undergoing infratentorial craniotomy. A total of 105 patients who underwent infratentorial craniotomy were randomized into either the ERAS group (n?=?50) or the control group (n?=?55). Primary outcomes were the incidence of vomiting, nausea score, and use of rescue antiemetic during the first 72?h after surgery. Secondary outcomes included postoperative anxiety level, sleep quality, and complications. RESULTS:Over the entire 72?h post-craniotomy observation period, the cumulative incidence of vomiting was significantly lower in the ERAS group than in the control group. Meanwhile, the incidence of vomiting was significantly lower in the ERAS group on postoperative days (PODs) 2 and 3. Notably, the proportion of patients with mild nausea (VAS 0-4) was higher in the ERAS group as compared to the control group on PODs 2 or 3. Additionally, the postoperative anxiety level and quality of sleep were significantly better in the ERAS group. CONCLUSION:Successful implementation of our ERAS protocol in infratentorial craniotomy patients could attenuate postoperative anxiety, improve sleep quality, and reduce the incidence of PONV, without increasing the rate of postoperative complications. TRIAL REGISTRATION:ChiCTR-INR-16009662, 27 Oct 2016, Clinical study on the development and efficacy evaluation of Enhanced Recovery After Surgery (ERAS) in Neurosurgery.
Project description:A study was undertaken to evaluate the effectiveness of acupuncture as an anti-emetic in patients undergoing minor gynaecological surgery. 100 patients were studied divided into study group (Group I) and control group (Group II) of 50 patients each. In group I patients, acupuncture needle was inserted at acupuncture point P6, 10 minutes before induction of anesthesia. In group II, no acupuncture was used. Anaesthetic technique was similar in both the groups. Five patients (10%) in group I and twenty (40%) in group II had one or more emetic episodes. These results show that acupuncture can be one of the modalities for the prevention of nausea and vomiting in postoperative period and its use as an anti-emetic should be explored further.
Project description:Dexamethasone is widely used for postoperative nausea and vomiting (PONV) prophylaxis, but its effect on PONV prevention in paediatric patients is validated only in short minor surgical procedures. In this study, we aimed to determine whether a single dose of dexamethasone reduces PONV in highly invasive surgeries that require opioid-based postoperative analgesia. One hundred adolescents undergoing scoliosis correction surgery were randomized to receive intravenous dexamethasone 0.15 mg/kg (dexamethasone group) or saline (control group) at induction of anaesthesia. The primary outcome was the incidence of PONV in the 72 h postoperatively. Data for 98 patients were available for analysis. The 72-h incidence of PONV was significantly lower in the dexamethasone group than in the control group (62.5% vs 84.0%; RR 0.74, 95% CI 0.58-0.96, P = 0.02). During the first and second 24-h postoperative intervals, fewer patients in the dexamethasone group received rescue antiemetics. Visual analogue scale scores for nausea and pain were lower in the dexamethasone group than in the control group during the first 24 h postoperatively. Dexamethasone did not increase the number of adverse events. The results of this study showed that a single dose of dexamethasone was effective for reducing PONV after paediatric scoliosis correction surgery.
Project description:Selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are reported to have potent antiemetic effects for postoperative nausea and vomiting (PONV). The purpose of this study was to prospectively evaluate the efficacy of palonosetron, granisetron, and ramosetron for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery.In this prospective, randomized observational study, 105 healthy female patients who were undergoing laparocopic hystectomy under general anaesthesia were enrolled (clinical trial number: NCT01752374, www.clinicaltrials.gov ). Patients were divided into three groups: the palonostron (0.075 mg i.v.; n = 35), the granisetron group (3 mg i.v.; n = 35), and the ramosetron group (0.3 mg i.v.; n = 35). The treatments were given before the end of surgery. The incidence of PONV, severity of nausea/vomiting, and the use of rescue antiemetic requirements during the first 48 h after surgery were evaluated.The overall incidence of PONV was 33.3 % for this series. The number of complete responders at 48 h after the surgery was 21 (60.0 %) for palonosetron, 24 (68.6 %) for granisetron, and 26 (71.4 %) for ramosetron, representing no statistical difference (P = 0.086).There were no significant differences in the overall incidence of postoperative nausea and vomiting and complete responders for palonosetron, granisetron and ramosetron group.NCT01752374 , www.clinicaltrials.gov .