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The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy

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ClinicalTrials.gov Identifier: NCT01617837
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to investigate if P6 acupressure may reduce postoperative nausea and vomiting in neurosurgical patients undergoing craniotomy.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Acupressure Craniotomy Device: P6 acupressure band Other: Placebo band Phase 2 Phase 3

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy. - a Randomized, Double-blinded, Placebo Controlled Study.
Study Start Date : November 2011
Primary Completion Date : August 2013
Study Completion Date : August 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: P6 acupressure group
In the end of the operation Sea-Band®, a single-sized elastic acupressure band with a plastic button, was placed unilaterally at the place of P6 (the P6 "Neiguan" acupoint, located about 3 cm proximal to the distal wrist, between the tendons of the flexor carpi radialis and the palmaris longus)to apply acupressure.
Device: P6 acupressure band
Comparison between groups 0-48 hours postoperatively.
Other Name: Sea-Band®
Placebo Comparator: Placebo group
In the end of the operation an identical Sea-Band® with no button and thereby no acupressure was placed unilaterally at the place of P6.
Other: Placebo band
Comparison between groups 0-48 hours postoperatively
Other Name: Sea-Band® with no acupressure


Outcome Measures

Primary Outcome Measures :
  1. Postoperative nausea and vomiting [ Time Frame: Postperative nauea and vomiting are registred regularly 0-48 hours postperatively. ]
    During 48 hours postoperatively the patients are evaluating their nausea, registered on the same formula as the frequencies of vomiting. The first evaluation will take part when arriving to the postoperative care unit and then every hour for the first six hours, every third hour until hour 24 and thereafter every sixth hour from hour 24-48. A Numerical Rating Scale (NRS) from 0-10 will be used, where 0 means no nausea at all and 10 the worst nausea possible. The patients will be asked about whether they have experienced any nausea within the previous period of time.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective infra-or supratentorial craniotomy
  • Age ≥ 18 years

Exclusion Criteria:

  • Patients not able to actively participate in the study according to mental status or communicating problems and patients receiving an antiemetic less than twelve hours before surgery
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617837


Locations
Sweden
The Department of Neurosurgery, Umeå University Hospital
Umeå, Västerbotten, Sweden, 90185
Sponsors and Collaborators
Umeå University
Investigators
Study Director: Ulrica Nilsson, PhD Umeå University
More Information

Responsible Party: Ulrica G Nilsson, PhD, Associate Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01617837     History of Changes
Other Study ID Numbers: 2011-281-31M
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013

Keywords provided by Ulrica G Nilsson, Umeå University:
Postoperative nausea and vomiting
P6 acupressure
Craniotomy.

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes