Effect of Transcutaneous Acupoint Electrical Stimulation on Postoperative Spontaneous Voiding for Laparoscopic Cholecystectomy Patients：A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tianjin Nankai Hospital
- Enrollment
- 1,948
- Locations
- 1
- Primary Endpoint
- The first spontaneous voiding after surgery
Study Overview
Brief Summary
- Title: Effect of Transcutaneous Acupoint Electrical Stimulation on postoperative spontaneous voiding for Laparoscopic Cholecystectomy patients：A Randomized Clinical Trial
- Research center: Multicenter
- Design of the research: A randomized, double-blind and parallel controlled study
- Object of the research: Patients （40≤age<75 years）planing to elective laparoscopic cholecystectomy under general anesthesia without preoperative placement of catheter.
- Sample size of the research: A total of 1,200 patients,600 cases in each group
- 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.
- Aim of the research: Evaluate the effect of TAES on the postoperative spontaneous voiding in patients for Laparoscopic Cholecystectomy (LC ).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Subjects who have signed informed consent were assigned to either TEAS group or control group on the basis of digital random numbers generated by SPSS.23.0 software. The acupuncturist(Z.-Y.) was informed of the randomization allocation each subject by a concealed envelope, just before the onset of TEAS. And during the treatment, the screen of all acupuncture treatment instruments was covered from to ensure the anesthesiologist and surgeon blinded. The acupuncturist, statistician, and data collectors work independently and only perform assigned tasks, besides after the agreement is initiated, all researchers will not have any private communication with the study.
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 40 years old and < 75 years old, gender and nationality are not limited;
- •Patients undergoing elective laparoscopic cholecystectomy under general anesthesia
- •agree to participate in this study and sign the informed consent;
Exclusion Criteria
- •Refused to participate in this study;
- •laparotomy or preventive indwelling catheter;
- •There are obvious symptoms of urinary difficulty caused by various causes recently;
- •Patients who are have treatment taboo with skin injury or insensitivity to acupoint stimulation.
- •Critical condition (preoperative ASA grade ≥ IV grade); severe renal impairment (need to undergo renal replacement therapy); severe liver and kidney dysfunction (Child-Pugh grade C);
- •There are other circumstances where it is not appropriate to participate in this study
Arms & Interventions
TAES treatment
Patients in the treatment group receive Transcutaneous Acupoint Electrical Stimulation (TAES) at Zhongji ( CV3),Guanyuan ( CV4), bilaterally Sanyinjiao ( SP6) and bilaterally Ciliao ( BL32) points by electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China).After "Deqi", electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained until the end of treatment.
Intervention: TAES treatmen (Device)
Sham TAES treatment
Participants in the control group receive shallow TAES at SP6, BL32 ,CV3 and CV4 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the acuponit is shamed without manual stimulation and "Deqi" and the stimulation apparatus is inefficiency without actual current output.
Intervention: Sham TAES treatmen (Device)
Outcomes
Primary Outcomes
The first spontaneous voiding after surgery
Time Frame: an average of 1 year
Record the time from the end of the procedure to the patient's first spontaneous postoperatively, and record the amount of urine and discomfort
Secondary Outcomes
- Incidence Urinary tract complications after surgery (including re-hospitalization)(an average of 1 year)
- NRS pain scores(12 months)
- The effects on postoperative sleep quality scores(12 months)
- symptoms of postoperative voiding(an average of 1 year)
- postoperative catheterization rate(12 months)
- Anxiety and depression assessment(an average of 1 year)
- Length of stay in hospital after surgery(an average of 1 year)
Investigators
Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Tianjin Nankai Hospital