Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Vomiting; Nausea; Cholecystitis

Treatments: Other: stimulation; Other: no stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03088696

Neiguan PC6

Details and patient eligibility

About

Assessment of the effectiveness of PC 6 "Neiguan" with conventional acupuncture for preventing PONV (PostOperative Nausea and Vomiting) after laparoscopic surgery.

Full description

Utilizing acustimulation, the effect of PC 6 "Neiguan" (acupuncture point Pericardium 6) has been studied in PONV . Conventional acupuncture has not been tested yet in laparoscopic cholecystectomy.

The incidence of postoperative vomiting during the first 24 hours is the main outcome. Secondary outcomes include: complete response rate, total rescue ondansetron dose used and patient satisfaction with PONV management.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients
• > 18 y
• General anesthesia
• Undergoing laparoscopic surgery
• Patient with American Society of Anesthesiologists physical status I-II
• Written informed consent

Exclusion criteria

• Pregnant women and breastfeeding
• Patient with cardiac disease
• Surgery more than 2 h
• No bowel surgery
• Signs of skin infection at or near the purposed site of the acupuncture point
• Patient with American Society of Anesthesiologists physical status IIII-IV

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups, including a placebo group

stimulation of the acupuncture point

Active Comparator group

Description:

a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"

Treatment:

Other: stimulation

no stimulation of the acupuncture point

Placebo Comparator group

Description:

only a bandage will be applied at pericardium channel 6, point "Neiguan"

Treatment:

Other: no stimulation