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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00151099
Recruitment Status : Withdrawn (There is no possibility to reach the target patient number within the set time frame)
First Posted : September 8, 2005
Last Update Posted : December 18, 2015
Sponsor:
Information provided by:
University Hospital Muenster

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date December 18, 2015
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2007)
gastric residual at induction of anesthesia
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
Gastric residual at induction of anesthesia
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • postoperative wellness
  • thermoregulation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Preoperative Oral Administration of a High Caloric Drink With Protein
Official Title  ICMJE Safety of Preoperative Oral Administration of a High Caloric Drink With Protein in Patients With Dysgnathia
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Postoperative Nausea and Vomiting
Intervention  ICMJE Drug: high caloric drink with protein
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 17, 2015)
0
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
72
Estimated Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with surgery for dysgnathia

Exclusion Criteria:

  • Diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151099
Other Study ID Numbers  ICMJE 03-Anast-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital Muenster
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christiane Goeters, MD Department of Anesthesiology and Intensive Care, University Hospital Muenster
PRS Account University Hospital Muenster
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP