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Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TEAS
TEAS without electrical stimulation
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting;TEAS

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-50 years old, BMI 15~40kg/m2, ASAI-III;
  • Laparoscopic non-gastrointestinal surgery under general anesthesia;
  • Postoperative Nausea and Vomiting Apfel ≥3;
  • Understand and sign an informed consent form and cooperate with the intervention and evaluation;

Exclusion Criteria:

  • Pregnancy, lactation period;
  • Taboos of transcutaneous electrical stimulation: skin allergy, damage, infection and itching at test acupoints; allergy to tape; pacemaker implanter;
  • Identify/discriminate a history of alcohol, opioids or other drugs abuse;
  • Admission to ICU after surgery;
  • Participation in other clinical studies within 3 months before admission to this study;

Sites / Locations

  • First Affiliated Hospital of Xian JiaotongUniversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control Group

TEAS Group

Arm Description

Same as TEAS group but without electrical stimulation

Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min

Outcomes

Primary Outcome Measures

Incidence of PONV within 24 hours
Whether or not nausea or vomiting happens

Secondary Outcome Measures

The first nausea
the time point of the first nausea.
The first nausea's Visual Analogue Scale
the Visual Analogue Scale of the first nausea : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ,on the left (no nausea) and on the right (extreme nausea). The patient is asked to mark their current nausea level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no nausea" anchor point.
The first vomiting
the time point the first vomiting
The first vomiting's Visual Analogue Scale
the Visual Analogue Scale of the first vomiting : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ,on the left (no vomitting) and on the right (extreme vomiting). The patient is asked to mark their current vomiting level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no vomiting" anchor point.
Total nausea frenquency in postoperative 24 hours
the total nausea times of the subjects
The Visual Analogue Scale of nausea in postoperative 24 hours
the Visual Analogue Scale of nausea in postoperative 24 hours : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ,on the left (no nausea) and on the right (extreme nausea). The patient is asked to mark their current nausea level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no nausea" anchor point.
Total vomiting frenquency in postoperative 24 hours
the total vomiting times of the subjects
The Visual Analogue Scale of vomiting in postoperative 24 hours
the Visual Analogue Scale of vomiting in postoperative 24 hours : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ,on the left (no vomitting) and on the right (extreme vomiting). The patient is asked to mark their current vomiting level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no vomiting" anchor point.
40-itemquality of recovery score
The quality of postoperative life recovery was assessed by questionnaire. The content mainly included five aspects, physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items) and pain (7 items).
Postoperative PONV complications
The incidence of dizziness, headache, electrolyte imbalance, aspiration, aspiration pneumonia, and wound dehiscence
Postoperative hospital stay
The interval between the date of discharge and the date of surgery.

Full Information

First Posted
July 29, 2019
Last Updated
August 17, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04043247
Brief Title
Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting
Official Title
Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting: a Multicenter, Evaluator-Blind, Randomized and Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2019 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
December 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative nausea and vomiting(PONV) refers to at least one nausea, retching or vomiting after operation, or any combination of the above symptoms. The incidence of PONV in high-risk patients can reach 61%-79%. PONV can not only cause dizziness and headache, but also cause disturbance of acid-base balance of water and electrolyte, wound dehiscence, formation of incisional hernia, aspiration, and aspiration pneumonia, leading to prolonged hospitalization, increased medical expenses, and reduced surgical satisfaction. At present, the guidelines for prevention and treatment of PONV and the consensus of experts suggest that identifying high-risk patients according to Apfel risk score ≥3 points, reducing baseline PONV risks, and implementing multimodal PONV prophylaxis. However, the incidence of PONV in high-risk patients is still as high as 20% even if 2-3 drugs are combined used for prevention and treatment. It is difficult to further reduce the incidence of PONV by adding different kinds or dosages of drugs, while drug-related side effects are increasing gradually. Acupuncture (electroacupuncture, transcutaneous electrical acupoint stimulationTEAS, transcutaneous electrical nerve stimulation, etc.) is a safe, effective, non-toxic side-effect non-drug treatment method. A large number of studies have confirmed that acupuncture can reduce the incidence of PONV, and it is expected to become an important supplement to drug treatment of PONV, but there are quality defects such as small sample size, inaccurate intervention and so on. At the same time, most acupuncture studies aim to compare the efficacy of PONV with drug therapy, without considering the clinical situation, using acupuncture treatment based on drug standard treatment to further reduce the incidence of PONV, thus limiting the clinical application value of acupuncture. On the basis of standardized drug prevention and treatment of PONV, TEAS will be used to further reduce the incidence of PONV and promote rapid recovery of patients. This study will strongly demonstrate that acupuncture can break through the bottleneck of drug treatment and provide evidence for the application of acupuncture in modern perioperative clinical medicine.
Detailed Description
This study intends to carry out a high-quality clinical research with design specifications, large sample, multi-center, evaluator blinded, randomized and controlled methods. From September 1, 2019 to October 30, 2020, patients undergoing laparoscopic non-gastrointestinal surgery under general anesthesia will be recruited, based on the combination of dexamethasone and 5-HT3 antagonist, the efficacy of TEAS stimulation Neiguan (P6) and Zusanli (ST36) in the prevention and treatment of PONV will be verified. In TEAS group, bilateral P6 and ST36 TEAS intervention after removal tracheal intubation and on the first day after surgery, a total of 2 times, 30 minutes each time, 2/10 Hz low frequency sparse wave, 6-9 mA. The patients will be given maximum intensity stimulation at all points during the intervention.To ensure the blindness of the evaluator, the time of evaluation will be on the afternoon of the first and the second day, and the 30 days after the operation, and three evaluations will be made. The main indicators are the incidence of PONV 24 hours after operation, and the secondary indicators are the quantitative indicators of PONV and the indicators of rapid recovery after operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative Nausea and Vomiting;TEAS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1655 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Same as TEAS group but without electrical stimulation
Arm Title
TEAS Group
Arm Type
Experimental
Arm Description
Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min
Intervention Type
Device
Intervention Name(s)
TEAS
Intervention Description
Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min
Intervention Type
Device
Intervention Name(s)
TEAS without electrical stimulation
Intervention Description
Bilateral Neiguan and Zusanli acupuncture points, with no electrical stimulation
Primary Outcome Measure Information:
Title
Incidence of PONV within 24 hours
Description
Whether or not nausea or vomiting happens
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
The first nausea
Description
the time point of the first nausea.
Time Frame
24 hours after surgery
Title
The first nausea's Visual Analogue Scale
Description
the Visual Analogue Scale of the first nausea : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ,on the left (no nausea) and on the right (extreme nausea). The patient is asked to mark their current nausea level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no nausea" anchor point.
Time Frame
24 hours after surgery
Title
The first vomiting
Description
the time point the first vomiting
Time Frame
24 hours after surgery
Title
The first vomiting's Visual Analogue Scale
Description
the Visual Analogue Scale of the first vomiting : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ,on the left (no vomitting) and on the right (extreme vomiting). The patient is asked to mark their current vomiting level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no vomiting" anchor point.
Time Frame
24 hours after surgery
Title
Total nausea frenquency in postoperative 24 hours
Description
the total nausea times of the subjects
Time Frame
24 hours after surgery
Title
The Visual Analogue Scale of nausea in postoperative 24 hours
Description
the Visual Analogue Scale of nausea in postoperative 24 hours : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ,on the left (no nausea) and on the right (extreme nausea). The patient is asked to mark their current nausea level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no nausea" anchor point.
Time Frame
24 hours after surgery
Title
Total vomiting frenquency in postoperative 24 hours
Description
the total vomiting times of the subjects
Time Frame
24 hours after surgery
Title
The Visual Analogue Scale of vomiting in postoperative 24 hours
Description
the Visual Analogue Scale of vomiting in postoperative 24 hours : the Visual Analog Scale (VAS) is a 10 cm line with anchor statements ,on the left (no vomitting) and on the right (extreme vomiting). The patient is asked to mark their current vomiting level on the line. The examiner scores the VAS by measuring the distance in either centimeters (0 to 10) or millimeters (0 to 100) from the "no vomiting" anchor point.
Time Frame
24 hours after surgery
Title
40-itemquality of recovery score
Description
The quality of postoperative life recovery was assessed by questionnaire. The content mainly included five aspects, physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items) and pain (7 items).
Time Frame
24 hours after surgery
Title
Postoperative PONV complications
Description
The incidence of dizziness, headache, electrolyte imbalance, aspiration, aspiration pneumonia, and wound dehiscence
Time Frame
30 days after surgery
Title
Postoperative hospital stay
Description
The interval between the date of discharge and the date of surgery.
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-50 years old, BMI 15~40kg/m2, ASAI-III; Laparoscopic non-gastrointestinal surgery under general anesthesia; Postoperative Nausea and Vomiting Apfel ≥3; Understand and sign an informed consent form and cooperate with the intervention and evaluation; Exclusion Criteria: Pregnancy, lactation period; Taboos of transcutaneous electrical stimulation: skin allergy, damage, infection and itching at test acupoints; allergy to tape; pacemaker implanter; Identify/discriminate a history of alcohol, opioids or other drugs abuse; Admission to ICU after surgery; Participation in other clinical studies within 3 months before admission to this study;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Wang, MD,PHD
Organizational Affiliation
First Affiliated Hospital of Xian JiaotongUniversity
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xian JiaotongUniversity
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
029710061
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35360742
Citation
Gao W, Zhang L, Han X, Wei L, Fang J, Zhang X, Zhang J, Wang H, Zhou Q, Wang C, Chen W, Ni X, Yang L, Du R, Wang G, Liu B, Li Y, Zhang S, Wang Q. Transcutaneous Electrical Acupoint Stimulation Decreases the Incidence of Postoperative Nausea and Vomiting After Laparoscopic Non-gastrointestinal Surgery: A Multi-Center Randomized Controlled Trial. Front Med (Lausanne). 2022 Mar 14;9:766244. doi: 10.3389/fmed.2022.766244. eCollection 2022.
Results Reference
derived

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Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting

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