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

Zhi-Hong Lu, Hai-Long Dong, Jia-Wen Huang-Fu, Xiao-Jian Fan, Wei-Xian Zhao, Su Min, Wei Zhang, Ming-Fu Liu, Yong-Hui Wang, Li-Ni Wang, Li-Ze Xiong, Zhi-Hong Lu, Hai-Long Dong, Jia-Wen Huang-Fu, Xiao-Jian Fan, Wei-Xian Zhao, Su Min, Wei Zhang, Ming-Fu Liu, Yong-Hui Wang, Li-Ni Wang, Li-Ze Xiong

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.

Keywords: Elderly patients; Postoperative complication; Study protocol; Transcutaneous electric acupoint stimulation.

Conflict of interest statement

Authors’ information

ZhL: MD, PhD, Associate Professor, senior consultant of Anesthesiology. HlD: MD, PhD, Professor, senior consultant of Anesthesiology. JwHf: Resident of Anesthesiology. XjF: Resident of Anesthesiology. WxZ: MD, PhD, Professor, senior consultant of Anesthesiology. WZ: MD, PhD, Professor, senior consultant of Anesthesiology. SM: MD, PhD, Professor, senior consultant of Anesthesiology. MfL: MD, Attendant of Anesthesiology. YhW: MD, Attendant of Anesthesiology. LnW: MD, Attendant of Anesthesiology LzX: MD, PhD, Professor, senior consultant of Anesthesiology.

Ethics approval and consent to participate

Ethics approval of the study was obtained from the Ethics Review Committee of Xijing Hospital, the Fourth Military Medical University (20162019-X-1). Researchers introduced the specific intervention and instruct the included patients on their rights before the study verbally and by the informed consent form.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure. Interventions and assessments will be administered at different time points (indicated by X). See description within the manuscript for more details. TEAS transcutaneous electric acupoint stimulation

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