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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05396716
Other study ID # XJH-A-20220410
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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