Prevention of Postoperative Nausea and Vomiting (PONV) by... | NCT00275483

Studies
Prevention of Postoperative Nausea and Vomiting (PONV) by Acupressure

NCT00275483

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

May 28, 2008Estimated

Enrollment

132Actual

Phase

Phase 4

Conditions

Postoperative Nausea and Vomiting
Acupressure Point P6

Interventions

Vital-band (R)

Countries

Denmark

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

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Oct 2005Actual

Completion Date

Feb 2007Actual

First Submitted Date

Jan 10, 2006

First Submission Date that Met QC Criteria

Jan 10, 2006

First Posted Date

Jan 12, 2006Estimated

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

May 27, 2008

Last Update Posted Date

May 28, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to determine whether stimulation to the akupressurpoint P6 with a recently developed bracelet are effective preventing postoperative nausea and vomiting

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Name	Type	Description	Arm Group Labels	Other Names
Vital-band (R)	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative nausea and vomiting

Secondary Outcomes

Measure	Description	Time Frame
1: The use of conventionel antiemetic treatment.
2: Lenght of stay in the perioperative unit.
3: overall lenght of stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female,
Non-smoker,
>18 years,
ASA 1 or 2,
Signed patient information,
IV-anaestesia.

Exclusion Criteria:

Male,
Smoker,
ASA 3 or 4,
Pregnancy,
Nausea and vomiting within the last 24 h before operation,
Diabetes,
Carpaltunnel syndrome,
Lymphedema of arms,
Eczema of forearm,
Patients who earlier has undergone removal of lymph nodes in the armpits,
Inhalation anaestesia.

Accepts Healthy Volunteers

Sex

Female

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

Not provided

Overall Officials

Name	Affiliation	Role
Birgitte Majholm, MD	Herlev Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev University Hospital, department of anaestesiology		Copenhagen	Herlev	2730	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

Not provided

Browse Branches

Not provided