Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting

NCT05396716 | Unknown

• 1 other identifier: XJH-A-20220410
• Study Type: interventional
• Target: 158
• Locations: 0 countries
• Sites: N/A

Brief Summary

Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.

Conditions

PONV

Keywords

transcutaneous electrical acupoint stimulation; liver surgery

Outcome Measures

Primary Outcomes (1)

• incidence of nausea and vomiting by 24 hours after surgery

  from end of surgery to 24 hours after surgery, in a total of 24 hours

Secondary Outcomes (9)

• incidence of nausea and vomiting by 48 hours after surgery

  from end of surgery to 48 hours after surgery, in a total of 48 hours

• incidence of nausea and vomiting in PACU (post-anesthesia care unit)

  from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes

• score of nausea and vomiting by 24 hours after surgery

  from end of surgery to 24 hours after surgery, in a total of 24 hours

• score of nausea and vomiting by 48 hours after surgery

  from end of surgery to 48 hours after surgery, in a total of 48 hours

• score of nausea and vomiting in PACU(post-anesthesia care unit)

  from end of surgery to discharge from PACU, in an average of 30 minutes

Study Arms (2)

transcutaneous electrical acupoint stimulation

EXPERIMENTAL

Device: transcutaneous electrical acupoint stimulation

Control

NO INTERVENTION

Interventions

transcutaneous electrical acupoint stimulation DEVICE

Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.

Also known as: TEAS

transcutaneous electrical acupoint stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years
• scheduled for elective liver surgery under general anesthesia

You may not qualify if:

• body mass index less than 18 kg/m2 or higher than 30 kg/m2
• American Society of Anesthesiologists status higher than Ⅲ
• patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
• suspected or existed abuse of drug or alcohol
• pregnant or breeding women
• history of neurological or psychiatric disease

Sponsors & Collaborators

• Zhihong LU: lead

Related Publications (1)

• Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.

  PMID: 26522652 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Central Study Contacts

Zhihong Lu

CONTACT

+8613891975018; deerlu23@163.com

Shan He

CONTACT

8684775343; 1411950442@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The stimulator is put in an opaque box
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 31, 2022
• Study Start: May 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share