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

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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.

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 Type

Interventional

Primary Outcome

Vomiting and Nausea

Secondary Outcome

 Use of antiemetic

Condition

Cholecystitis

Intervention

stimulation

Study Arms / Comparison Groups

 stimulation of the acupuncture point
Description:  a acupuncture needle and bandage will be applied at pericardium channel 6, point "Neiguan"

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

200

Start Date

February 1, 2018

Completion Date

September 1, 2019

Primary Completion Date

May 1, 2019

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jan Poelaert, PhD MD, +3224763134, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT03088696

Organization ID

Neiguan PC6

Responsible Party

Principal Investigator

Study Sponsor

Universitair Ziekenhuis Brussel

Study Sponsor

Jan Poelaert, PhD MD, Study Chair, Universitair Ziekenhuis Brussel

Verification Date

April 2019