General AnesthesiaNCT00468494
Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?
An observational study of General Anesthesia and Hyperglycemia, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- General Anesthesia, Hyperglycemia
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non-diabetic adults undergoing surgery
Who may be able to join
- Elective surgery
- 18-80 years of age
Who cannot join
- Known diabetics
- Pregnant patients
- Cardiac surgery patients
- Liver transplant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Medicine & Dentistry of New Jersey
Newark, New Jersey, 07101
About this study
Official title: Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia
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.
Read the 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.
- Conditions
- General Anesthesia, Hyperglycemia
- Keywords
- non diabetic, catabolic energy state
- Medical subject headings
- Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose level at specific points
Measured: Intraoperatively and in the PACU
Secondary outcomes (1)
pt telephoned to assess for complications
Measured: within 2 weeks of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startSep 2006
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vasanti Tilak, MD, Principal investigator, University of Medicine & Dentistry of New Jersey-NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468494
- Sponsor's protocol ID
- 0120060208
- Status last verified
- Jan 2013
- First submitted
- 30 Apr 2007
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia
- ClinicalTrials.gov ID
- NCT00468494
- Acronym / sponsor ID
- 0120060208
- Conditions
- General Anesthesia, Hyperglycemia
- Keywords
- non diabetic, catabolic energy state
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-diabetic adults undergoing surgery
Key inclusion criteria (2 listed)
- Elective surgery
- 18-80 years of age
Key exclusion criteria (4 listed)
- Known diabetics
- Pregnant patients
- Cardiac surgery patients
- Liver transplant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
glucose level at specific points
Time frame: Intraoperatively and in the PACU
1 secondary outcome
pt telephoned to assess for complications
Time frame: within 2 weeks of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasanti Tilak, MD principal investigator
University of Medicine & Dentistry of New Jersey-NJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Hyperglycemia, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose level at specific points (time frame: Intraoperatively and in the PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013.