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

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Unknown status

CT.gov ID

NCT03088696

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cholecystitis Vomiting Nausea	Other: stimulation Other: no stimulation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized comparative double blind prospective studyrandomized comparative double blind prospective study

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The care provider get's an envelope from the study nurse when going to the patient in the operating room. Only the study nurse knows if an acupuncture needle is in the envelope.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: stimulation of the acupuncture point a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"	Other: stimulation activation of the acupuncture point
Placebo Comparator: no stimulation of the acupuncture point only a bandage will be applied at pericardium channel 6, point "Neiguan"	Other: no stimulation no activation of the acupuncture point

Arm

Intervention/Treatment

Active Comparator: stimulation of the acupuncture point

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

Other: stimulation

activation of the acupuncture point

Placebo Comparator: no stimulation of the acupuncture point

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

Other: no stimulation

no activation of the acupuncture point

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Use of antiemetic [24 hours]
dosage in mg
Use of analgesia [24 hours]
dosage in mg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Jette	Vlaams-Brabant	Belgium	1090

Sponsors and Collaborators

Universitair Ziekenhuis Brussel

Investigators

Study Chair: Jan Poelaert, PhD MD, Universitair Ziekenhuis Brussel
Principal Investigator: Güngör Badaş, Nurse, Universitair Ziekenhuis Brussel
Study Director: Vincent Van Tittelboom, MD, Universitair Ziekenhuis Brussel
Study Director: Philippe Bral, MD, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT03088696

Other Study ID Numbers:

Neiguan PC6

First Posted:

Mar 23, 2017

Last Update Posted:

Apr 17, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel

laparoscopic

acupuncture

Additional relevant MeSH terms:

Cholecystitis

Vomiting

Study Results

No Results Posted as of Apr 17, 2019