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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ulrica G Nilsson, Umeå University
ClinicalTrials.gov Identifier:
NCT01617837
First received: June 9, 2012
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Postoperative nausea and vomiting [ Time Frame: Postperative nauea and vomiting are registred regularly 0-48 hours postperatively. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ulrica G Nilsson, PhD, Associate Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01617837     History of Changes
Other Study ID Numbers: 2011-281-31M
Study First Received: June 9, 2012
Last Updated: March 28, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013