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Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00468494
First received: April 30, 2007
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

Surgery performed during general anesthesia induces a stress effect on the body. Our plan is to identify population at risk of hyperglycemia during perioperative period.


Condition
General Anesthesia
Hyperglycemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • glucose level at specific points [ Time Frame: Intraoperatively and in the PACU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pt telephoned to assess for complications [ Time Frame: within 2 weeks of surgery ] [ Designated as safety issue: No ]

Enrollment: 308
Study Start Date: September 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective study to define the relationship between time profile of glucose control before, during and after surgery with patient variables, surgical variables and anesthetic variables. Serum glucose levels will be measured preoperatively and then at 30 minute intervals during surgery. Pain score, pain medication and glucose levels will be measured in the post anesthesia recovery room. Subjects will be contacted 2 weeks following the date of surgery to determine the incidence of postoperative complications.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

non-diabetic adults undergoing surgery

Criteria

Inclusion Criteria:

  • Elective surgery
  • 18-80 years of age

Exclusion Criteria:

  • Known diabetics
  • Pregnant patients
  • Cardiac surgery patients
  • Liver transplant patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468494

Locations
United States, New Jersey
University of Medicine & Dentistry of New Jersey
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Vasanti Tilak, MD University of Medicine & Dentistry of New Jersey-NJMS
  More Information

No publications provided

Responsible Party: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00468494     History of Changes
Other Study ID Numbers: 0120060208
Study First Received: April 30, 2007
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:
non diabetic
catabolic energy state

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013