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Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Transcutaneous electric acupoint stimulation (TEAS) has shown benefits when used peri-operatively. However, the role of numbers of areas with acupoint stimulation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using TEAS in elderly patients subjected to gastrointestinal surgery, and comparing dual-acupoint and single-acupoint stimulation. METHODS/DESIGN:A multicenter, randomized, controlled, three-arm design, large-scale trial is currently undergoing in four hospitals in China. Three hundred and forty-five participants are randomly assigned to three groups in a 1:1:1 ratio, receiving dual-acupoint TEAS, single-acupoint TEAS, and no stimulation, respectively. The primary outcome is incidence of pulmonary complications at 30?days after surgery. The secondary outcomes include the incidence of pulmonary complications at 3?days after surgery; the all-cause mortality within 30?days and 1?year after surgery; admission to the intensive care unit (ICU) and length of ICU stay within 30?days after surgery; the length of postoperative hospital stay; and medical costs during hospitalization after surgery. DISCUSSION:The result of this trial (which will be available in September 2019) will confirm whether TEAS before and during anesthesia could alleviate the postoperative pulmonary complications after gastrointestinal surgery in elderly patients, and whether dual-acupoint stimulation is more effective than single-acupoint stimulation. TRIALS REGISTRATIONS:ClinicalTrials.gov, ID: NCT03230045 . Registered on 10 July 2017.

SUBMITTER: Lu ZH

PROVIDER: S-EPMC6280525 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial.

Lu Zhi-Hong ZH Dong Hai-Long HL Huang-Fu Jia-Wen JW Fan Xiao-Jian XJ Zhao Wei-Xian WX Min Su S Zhang Wei W Liu Ming-Fu MF Wang Yong-Hui YH Wang Li-Ni LN Xiong Li-Ze LZ

Trials 20181204 1

<h4>Background</h4>Transcutaneous electric acupoint stimulation (TEAS) has shown benefits when used peri-operatively. However, the role of numbers of areas with acupoint stimulation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using TEAS in elderly patients subjected to gastrointestinal surgery, and comparing dual-acupoint and single-acupoint stimulation.<h4>Methods/design</h4>A multicenter, randomized, controlled, three-arm design, large-scale trial is ...[more]

PMID: 30514358

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Project description:BackgroundPostoperative delirium is common in elderly patients following major surgery. This study aimed to assess the effect of transcutaneous electrical acupoint stimulation combined with auricular acupressure on the incidence of postoperative delirium among older patients undergoing major abdominal surgery.MethodsIn this single-center, randomized controlled clinical trial, 210 patients aged 65 years or older undergoing major abdominal surgery were randomized to receive either intervention treatment (transcutaneous electrical acupoint stimulation started at 30 min before anesthesia until the end of the surgery, followed by intermittent auricular acupressure in the first three postoperative days; n = 105) or standard care (n = 105). The primary outcome was the incidence of delirium at the first seven postoperative days or until hospitalization depended on which came first. Secondary outcomes included delirium severity, opioid consumption, postoperative pain score, sleep quality, length of postoperative hospital stay, and postoperative 30-day complications. Enrollment was from April 2019 to March 2020, with follow-up ending in April 2020.ResultsAll of the 210 randomized patients [median age, 69.5 years, 142 (67.6%) male] completed the trial. The incidence of postoperative delirium was significantly reduced in patients received intervention treatment (19/105 (18.1%) vs. 8/105 (7.6%), difference, -10.5% [95% CI, -1.5% to -19.4%]; hazard ratio, 0.41 [95% CI, 0.18 to 0.95]; P= 0.023). Patients in the control group had a higher postoperative Memorial Delirium Assessment Scale (4 vs. 3; difference, -1; 95% CI, -1 to 0; P = 0.014) and a greater increase in Pittsburgh Sleep Quality Index score from baseline to postoperative day three (2.5 vs. 2.0; difference, -1; 95% CI, -2 to -1; P < 0.001) than patients in the intervention group. No significant difference was observed as of other secondary outcomes.ConclusionIn elderly patients undergoing major abdominal surgery, transcutaneous electrical acupoint stimulation combined with auricular acupressure reduced the incidence of postoperative in-hospital delirium compared with standard care. A multicenter, randomized clinical trial with a larger sample size is necessary to verify these findings.Clinical trial registration[https://clinicaltrials.gov], identifier [NCT03726073].

Project description:ImportancePostoperative nausea and vomiting (PONV) gives patients a bad experience and negates their good recovery from surgery.ObjectiveThis trial aims to assess the preventive effectiveness of transcutaneous electrical acupoint stimulation (TEAS) on the incidence of PONV in high-risk surgical patients.DesignThe large sample size, multicenter, evaluator-blinded, and randomized controlled study was conducted between September 3, 2019 to February 6, 2021.SettingThe 12 hospitals were from different Chinese provinces.ParticipantsAfter obtaining ethics approval and written informed consent, 1,655 patients with Apfel score ≥ 3 points were enrolled for selective laparoscopic non-gastrointestinal surgery under general anesthesia.InterventionsPatients were randomly allocated into the TEAS and Sham group with a 1:1 ratio. The TEAS group was stimulated on bilateral Neiguan and Zusanli acupoints after recovery from anesthesia on the surgical day and the next morning for 30 min, while the Sham group received an identical setting as TEAS but without currents delivered. Electronic patient self-reported scale was used to evaluate and record the occurrence of PONV.Main outcomes and measuresPrimary clinical end point is the incidence of PONV which was defined as at least one incidence of nausea, retching, or vomiting after operation within postoperative 24 h.ResultsCompared with the Sham treatment, the TEAS lowered the PONV incidence by 4.8% (29.4 vs. 34.2%, P = 0.036) and vomiting incidence by 7.4% (10.4 vs. 17.8%, P < 0.001). TEAS also lowered persistent nausea incidence and PONV scores and decreased PONV related complications and Quality of Recovery-40 scores (P < 0.05). TEAS lowered the 24 h PONV risk by 20% (OR, 0.80, 95% CI, 0.65 -0.98; P = 0.032), and lowered hazard ratio by 17% (HR, 0.83, 95% CI, 0.70-0.99; P = 0.035). Both TEAS and palonosetron were the independent PONV risk protective factors for 24 h PONV incidence and cumulative PONV incidence. The combination of TEAS and palonosetron was the most effective strategy to reduce the PONV incidence (P < 0.001).Conclusions and relevanceTEAS attenuated the PONV incidence and severity in high-risk surgical patients and may be applied clinically as a complement therapy to prevent PONV.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT04043247, identifier: NCT04043247.

Project description:BackgroundThis study aimed to evaluate the effect of perioperative transcutaneous electrical acupoint stimulation (TEAS) on postoperative cognitive dysfunction (POCD) in older patients who were diagnosed with gastrointestinal tumor and received radical resection of gastrointestinal tumors under general anesthesia.MethodsA total of 68 patients who received radical resection of gastrointestinal tumors under general anesthesia were randomly divided into two groups. TEAS group patients received TEAS treatment. The treatment time was 30 min before the induction of anesthesia until the end of the surgery, 1 day before operation and from the first day to the third day after the operation. Except on the day of surgery, we treated the patients for 30 min once a day. In the sham TEAS group, the electronic stimulation was not applied and the treatment was the same as the TEAS group. The primary outcome was perioperative cognition evaluated by the Mini-Mental State Examination (MMSE) and secondary outcomes were the perioperative level of interleukin-6 (IL-6), S100 calcium-binding protein β (S100β), and C-reactive protein (CRP).ResultsThe postoperative score of MMSE, orientation, memory, and short-term recall in the sham TEAS group was significantly lower than the preoperative and TEAS group (P < 0.05). The incidence of POCD in the TEAS group (21.88%) was lower than those in the sham TEAS group (40.63%). S100β, IL-6, and CRP in the TEAS group were significantly lower than those in the sham TEAS group on the third day after the operation (P< 0.05). Postoperative S100β, IL-6, and CRP in two groups were significantly higher than those before operation except for S100β on the third day after the operation in the TEAS group (P < 0.05).ConclusionsPerioperative TEAS treatment reduced the postoperative inflammatory response and increased the postoperative cognitive function score and decrease the incidence of POCD in geriatric patients with gastrointestinal tumor.Trial registrationClinicalTrials.gov NCT04606888 . Registered on 27 October 2020. https://register.clinicaltrials.gov .

Project description:IntroductionAbdominal surgery is associated with common complications, including decreased or poor appetite, abdominal distension, abdominal pain caused by decreased or absent gastrointestinal motility, anal arrest with flatus and defecation, and nausea and vomiting resulting from the use of anaesthetics and opioid analgesics. These complications seriously affect postoperative recovery, prolong hospital stay and aggravate patient burden. This study aims to investigate for the first time the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with electroacupuncture (EA) therapy for rapid recovery after laparotomy for gastrointestinal surgery. There have been no clinical studies of this combination therapy.Methods and analysisThis will be a prospective, single-centre, three-arm, randomised controlled trial. A total of 480 patients undergoing abdominal surgery will be stratified according to surgery type (ie, gastric or colorectal procedure) and randomised into three groups; namely, the EA, TEAS +EA and control groups. The control group will receive enhanced recovery after surgery (ERAS)-standardised perioperative management, including preoperative education, optimising the anaesthesia scheme, avoiding intraoperative hypothermia, restrictive fluid infusion and reducing surgical trauma. The EA group will receive EA stimulation at LI4, PC6, ST36, ST37 and ST39 based on the ERAS-standardised perioperative management. Moreover, the TEAS +EA group will receive ERAS-standardised perioperative management; EA stimulation at the LI4, PC6, ST36, ST37 and ST39; and TEAS stimulation at ST21 and SP15. The primary outcome will be the GI-2 (composite outcome of time to first defaecation and time to tolerance of a solid diet). Secondary outcomes will include the time of first passage of flatus, time to first defaecation, time to tolerance of a solid diet, time to first ambulation, hospital duration from operation to discharge, pain and nausea vomiting scores on the Visual Analogue Scale, medication use, incidence of postoperative complications and evaluation of treatment modality acceptability. All statistical analyses will be performed based on the intention-to-treat principle.Ethics and disseminationEthics approval has been granted by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (approval number: 2021; number 52). The results are expected to be published in peer-reviewed journals.Trial registration numberChiCTR2100045646.

Project description:ObjectiveThis systematic review and meta-analysis aimed to evaluate the preventive effect of transcutaneous electrical acupoint stimulation on postoperative delirium in elderly surgical patients.MethodsPubMed, CENTRAL, China National Knowledge Infrastructure, and WanFang databases were searched for randomized controlled trials regarding the effect of transcutaneous electrical acupoint stimulation on preventing postoperative delirium in elderly patients undergoing any type of surgery. The primary outcome was the incidence of postoperative delirium. The secondary outcome was the duration of postoperative delirium. All analyses were conducted using RevMan 5.3 and Stata 13.0 software.ResultsTwelve trials with 991 participants were included, and most of them were at high/unclear risk of bias. Meta-analysis showed transcutaneous electrical acupoint stimulation could reduce the incidence of postoperative delirium (RR = 0.40, 95%CI = 0.29 to 0.55, p < 0.00001) and shorten the duration of postoperative delirium (MD = -0.97 days, 95%CI = -1.72 to -0.22, p = 0.01). Subgroup analyses demonstrated that transcutaneous electrical acupoint stimulation reduced the incidence of postoperative delirium in elderly patients undergoing orthopedic surgery and thoracic surgery, but not digestive surgery; transcutaneous electrical acupoint stimulation with dilatational wave and with continuous wave were both beneficial; and transcutaneous electrical acupoint stimulation was favored when compared to blank and sham control.ConclusionTranscutaneous electrical acupoint stimulation could reduce the incidence of postoperative delirium and shorten the duration of postoperative delirium in elderly surgical patients. The findings should be interpreted with caution due to weak evidence. High-quality, large sample, and multi-center trials are needed to further confirm the preliminary findings.Systematic review registration: https://inplasy.com/inplasy-2022-7-0096/, identifier: INPLASY202270096.

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Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial.

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Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial.

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