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

Not Applicable

• Conditions: Cholecystitis; Vomiting; Nausea
• Interventions: Other: stimulation; Other: no stimulation

• Registration Number: NCT03088696
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-23
• Study Start: 2018-02-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17
• Primary Completion: 2019-05-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stimulation of the acupuncture point	stimulation	a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"
no stimulation of the acupuncture point	no stimulation	only a bandage will be applied at pericardium channel 6, point "Neiguan"

Primary Outcome Measures

Name	Time	Method
Vomiting and Nausea	24 hours	numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive

Secondary Outcome Measures

Name	Time	Method
Use of antiemetic	24 hours	dosage in mg
Use of analgesia	24 hours	dosage in mg

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Vlaams-Brabant, Belgium