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

NCT ID: NCT03631160

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1948 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2020-08-24

Brief 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.

Conditions

Voiding Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

TAES treatmen

Intervention Type: DEVICE

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.

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.

Group Type: SHAM_COMPARATOR

Sham TAES treatmen

Intervention Type: DEVICE

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 .

Interventions

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.

Intervention Type: 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 .

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 40 years old and < 75 years old, gender and nationality are not limited;

2. Patients undergoing elective laparoscopic cholecystectomy under general anesthesia

3. agree to participate in this study and sign the informed consent;

Exclusion Criteria

1. Refused to participate in this study;

2. laparotomy or preventive indwelling catheter;

3. There are obvious symptoms of urinary difficulty caused by various causes recently;

4. Patients who are have treatment taboo with skin injury or insensitivity to acupoint stimulation.

5. 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);

6. There are other circumstances where it is not appropriate to participate in this study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin First Central Hospital

OTHER

Sponsor Role: collaborator

Tianjin Beichen Hospital

UNKNOWN

Sponsor Role: collaborator

Anyang People's Hospital

UNKNOWN

Sponsor Role: collaborator

Tianjin Nankai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jianbo Yu

Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianbo Yu, MD,PhD

Role: STUDY_CHAIR

Nankai Hospital of Tianjin

Locations

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

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Zhang YF, Li XY, Liu XY, Zhang Y, Gong LR, Shi J, Du SH, He SM, Li C, Li YT, Li N, Liu SS, Wu Y, Xie ZL, Pei ZC, Yu JB. Transcutaneous Electrical Acupoints Stimulation Improves Spontaneous Voiding Recovery After Laparoscopic Cholecystectomy: A Randomized Clinical Trial. World J Surg. 2023 May;47(5):1153-1162. doi: 10.1007/s00268-023-06924-7. Epub 2023 Feb 6.

Reference Type: DERIVED

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Other Identifiers

TianjinNH Clinic

Identifier Type: -

Identifier Source: org_study_id