Evaluation of PC 6 "Neiguan" With Conventional Acupunctur... | NCT03088696

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

NCT03088696

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Apr 17, 2019Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Cholecystitis
Vomiting
Nausea

Interventions

stimulation
no stimulation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

May 1, 2019Estimated

Completion Date

Sep 1, 2019Estimated

First Submitted Date

Mar 7, 2017

First Submission Date that Met QC Criteria

Mar 16, 2017

First Posted Date

Mar 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2019

Last Update Posted Date

Apr 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis BrusselPrincipal Investigator

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stimulation of the acupuncture point	Active Comparator	a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"	Other: stimulation
no stimulation of the acupuncture point	Placebo Comparator	only a bandage will be applied at pericardium channel 6, point "Neiguan"	Other: no stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stimulation	Other	activation of the acupuncture point	stimulation of the acupuncture point

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Use of antiemetic	dosage in mg	24 hours
Use of analgesia	dosage in mg	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Veerle Van Mossevelde, Data Nurse	Contact	+3224763134		veerle.vanmossevelde@uzbrussel.be
Dirk De Clippeleir, Data Nurse	Contact	+324763580		dirk.declippeleir@uzbrussel.be

Overall Officials

Name	Affiliation	Role
Jan Poelaert, PhD MD	Universitair Ziekenhuis Brussel	Study Chair
Güngör Badaş, Nurse	Universitair Ziekenhuis Brussel	Principal Investigator
Vincent Van Tittelboom, MD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis Brussel	Recruiting	Jette	Vlaams-Brabant	1090	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002764	Cholecystitis
D014839	Vomiting
D009325	Nausea

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D012817	Signs and Symptoms, Digestive

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

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.

Who Masked

ParticipantOutcomes Assessor