Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Patients
Condition: Voiding Disorders
Study type: Interventional

Summary: 
      1. Title: Effect of Transcutaneous Acupoint Electrical Stimulation on postoperative
           spontaneous voiding for Laparoscopic Cholecystectomy patients：A Randomized Clinical
           Trial

        2. Research center: Multicenter

        3. Design of the research: A randomized, double-blind and parallel controlled study

        4. Object of the research: Patients （40≤age<75 years）planing to elective laparoscopic
           cholecystectomy under general anesthesia without preoperative placement of catheter.

        5. Sample size of the research: A total of 1,200 patients,600 cases in each group

        6. Interventions: The acupuncture points for Transcutaneous Acupoint Electrical
           Stimulation(TAES) are Zhongji ( CV3),Guanyuan ( CV4),Sanyinjiao ( SP6) and Ciliao (
           BL32) points . In treatment group patients are treated with low-frequency pulse
           electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at
           bilateral of SP6 and BL 32 points during the operation,and treated with a similar method
           at CV6 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. Each devic is
           connected and maintained after "Deqi". Participants in the control group received
           nonacupoints (located 1 inch beside acupoints) and avoided manual stimulation and no
           "Deqi" without actual current output.

        7. Aim of the research: Evaluate the effect of TAES on the postoperative spontaneous
           voiding in patients for Laparoscopic Cholecystectomy (LC ).

        8. Outcome：Primary outcomes: The time of the first spontaneous voiding after surgery .

           Secondary outcomes: symptoms of postoperative voiding, the incidence of Postoperative
           dysuria,postoperative catheterization rate, catheterization time, incidence of related
           complications,as well as the effects on postoperative NRS pain and sleep quality scores
           etc.

        9. The estimated duration of the study：2 years.
    

Detailed description: 
      This study is a large sample, randomized, double-blinded, placebo-controlled and long-term
      follow-up design. In this study, bilateralZhongji ( CV3),Guanyuan ( CV4),Sanyinjiao ( SP6)
      and Ciliao ( BL32) points were selected for perioperative TAES treatment, accompanied with
      evaluating the postoperative spontaneous voiding, the incidence of Postoperative
      dysuria,postoperative catheterization rate, as well as the effects on postoperative NRS pain
      and sleep quality scores . To clarify the effect of TAES on the postoperative spontaneous
      voiding in patients for laparoscopic surgery is of great significance to the clinical
      applications and popularization of traditional acupuncture treatment perioperatively across
      the world.
    

Intervention name(s): TAES treatmen; Sham TAES treatmen
Intervention type(s): Device; Device
Intervention description(s): In the acupoints group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at SP6 and BL 32 points during the operation in the operating room ,and at CV3 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. After "Deqi", electroacupuncture stimulation apparatus is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 milliamp (mA) (gradually increase to the patient's maximum tolerance) and maintained until the end of treatment.; Participants in the acupoints group receive shallow acupointing at SP6, BL 32 ,CV3 and CV4 (nonacupoints located 1 inch beside acupoints, about 20mm).Specifically, the acupoint is shamed without manual stimulation and "Deqi" and the stimulation apparatus is inefficiency without actual current output .
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients undergoing elective laparoscopy cholecystectomy surgery were recruited and allocated into TEAS（transcutaneous electrical acupoint stimulation）group or control group
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laparoscopic Cholecystectomy; Transcutaneous Acupoint Electrical Stimulation; Postoperative spontaneous voiding; Postoperative Dysuria