search
Back to results

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

Primary Purpose

Cholecystitis, Vomiting, Nausea

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
stimulation
no stimulation
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholecystitis focused on measuring laparoscopic, acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitair Ziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

stimulation of the acupuncture point

no stimulation of the acupuncture point

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Use of antiemetic
dosage in mg
Use of analgesia
dosage in mg

Full Information

First Posted
March 7, 2017
Last Updated
April 16, 2019
Sponsor
Universitair Ziekenhuis Brussel
search

1. Study Identification

Unique Protocol Identification Number
NCT03088696
Brief Title
Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.
Official Title
Evaluation of PC 6 "Neiguan" With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Vomiting, Nausea
Keywords
laparoscopic, acupuncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized comparative double blind prospective study
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stimulation of the acupuncture point
Arm Type
Active Comparator
Arm Description
a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"
Arm Title
no stimulation of the acupuncture point
Arm Type
Placebo Comparator
Arm Description
only a bandage will be applied at pericardium channel 6, point "Neiguan"
Intervention Type
Other
Intervention Name(s)
stimulation
Intervention Description
activation of the acupuncture point
Intervention Type
Other
Intervention Name(s)
no stimulation
Intervention Description
no activation of the acupuncture point
Primary Outcome Measure Information:
Title
Vomiting and Nausea
Description
numeric from 0-4, 0= no vomiting, 1= nausea, 2= moderate, 3= multiple and 4= extensive
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Use of antiemetic
Description
dosage in mg
Time Frame
24 hours
Title
Use of analgesia
Description
dosage in mg
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veerle Van Mossevelde, Data Nurse
Phone
+3224763134
Email
veerle.vanmossevelde@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk De Clippeleir, Data Nurse
Phone
+324763580
Email
dirk.declippeleir@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, PhD MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Güngör Badaş, Nurse
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Van Tittelboom, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Philippe Bral, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Vlaams-Brabant
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veerle Van Mossevelde, Study Nurse
Phone
+32 2 476 31 34
Email
veerle.vanmossevelde@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Güngor Badas, nurse

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs