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Safety of Preoperative Oral Administration of a High Caloric Drink With Protein

This study has been withdrawn prior to enrollment.
(There is no possibility to reach the target patient number within the set time frame)
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00151099
First received: September 7, 2005
Last updated: August 17, 2007
Last verified: August 2007
History of Changes
  Purpose

The purpose of the study is to determine whether the oral administration of a high caloric drink with protein decreases the postoperative nausea and vomiting in patients with dysgnathia.


Condition Intervention Phase
Postoperative Nausea and Vomiting
 Drug: high caloric drink with protein
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Safety of Preoperative Oral Administration of a High Caloric Drink With Protein in Patients With Dysgnathia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • gastric residual at induction of anesthesia

Secondary Outcome Measures:
  • postoperative wellness
  • thermoregulation

Estimated Enrollment: 72
Study Start Date: September 2005
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with surgery for dysgnathia

Exclusion Criteria:

  • Diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151099

Locations
Germany
Department of Anesthesiology and Intensive Care, University Hospital Münster
Münster, Germany, D-48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Christiane Goeters, MD Department of Anesthesiology and Intensive Care, University Hospital Muenster
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00151099     History of Changes
Other Study ID Numbers: 03-Anast-05
Study First Received: September 7, 2005
Last Updated: August 17, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
preoperative nutrition
postoperative nausea and vomiting
Dysgnathia
anesthesia

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 21, 2013