Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Patients

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.

Conditions

• Voiding Disorders

Interventions

DEVICE

TAES treatmen

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.

DEVICE

Sham TAES treatmen

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 .

Sponsors & Collaborators

• Tianjin First Central Hospital

  collaborator OTHER

• Tianjin Beichen Hospital

  collaborator UNKNOWN

• Anyang People's Hospital

  collaborator UNKNOWN

• Tianjin Nankai Hospital

  lead OTHER

Principal Investigators

• Jianbo Yu, MD,PhD · Nankai Hospital of Tianjin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-20

Primary Completion

2020-06-21

Completion

2020-08-24

Countries

• China

Study Locations