Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting

PONV Clinical Trial

Official title:

Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Nausea and Vomiting After Liver Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05396716
• Other study ID #: XJH-A-20220410
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2022
• Source: Air Force Military Medical University, China
• Contact: Zhihong Lu
• Phone: +8613891975018
• Email: deerlu23[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• body mass index less than 18 kg/m2 or higher than 30 kg/m2
• American Society of Anesthesiologists status higher than ?
• 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

Related Conditions & MeSH terms

• PONV
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Device:
• transcutaneous electrical acupoint stimulation
Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhihong LU

References & 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;(11):CD003281. doi: 10.1002/14651858.CD003281.pub4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of recovery score at 24 hours after surgery		from end of surgery to 24 hours after surgery, in a total of 24 hours
Secondary	Quality of recovery score at 48 hours after surgery		from end of surgery to 48 hours after surgery, in a total of 48 hours
Secondary	postoperative in-hospital stay		from end of surgery to discharge from hospital, in an average of 7 days
Secondary	death by 6 months after surgery		from end of surgery to 6 months after surgery, in a total of 6 months