- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641653
Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period
Does the Administration of Preop Midazolam Assist in Maintaining Blood Glucose Norms in Non-diabetic Patient During the Perioperative Period
Study Overview
Detailed Description
Surgery performed during general anesthesia induces a stress response partially through a catabolic energy state. As a result, serum glucose may rise to levels which have been associated with major morbidity and mortality. In patients undergoing cardiac surgery, typically "tight glycemic control" strategies are used to prevent hyper- and hypo-glycemia in the perioperative period, before the effects of perioperative hyperglycemia begin to emerge. In one study a high percentage of patients in the control group had intraoperative blood glucose levels over 225. After one hour of surgery: 20%, after two hours: 28%, after three hours: 31% and in the post-anesthesia recovery room: 52% of patients. These high levels of glucose could be associated with significant post-operative morbidity such as wound infection and pneumonia as shown in the cardiac surgery population.
Glucose alterations induced by psychological stress have been studied in rats but not in humans.
Midazolam is a short acting benzodiazepine that depresses central nervous system. It is indicated for anxiolysis, amnesia and sedation. We hypothesize that the administration of midazolam may be beneficial in suppressing the catabolic energy state, maintaining normal glucose levels during this stressful period. This commonly available inexpensive drug, which is tolerated well by the majority of patients, may be useful in maintaining normal glucose levels and minimize adverse postoperative outcomes, such as wound and urinary tract infections and pneumonia.
We propose a prospective, single blind (subject only) randomized study to measure glucose levels in non diabetic patients undergoing both ventral and inguinal hernia repair. Patients scheduled for hernia repair will be approached on the morning of surgery (on E yellow) and following the completion of the informed consent process, a preoperative capillary glucose reading will be performed via the portable Abbott Freestyle™ Glucometer. Subjects with a preoperative reading of greater than 110 will be excluded from the study. Prior to the administration of any medication, we will ask all subjects to complete the State Trait Anxiety Inventory for Adults (STAI Form Y-1 and Y-2). This is a research instrument for anxiety in adults. It is comprised of 40 questions at a 6th grade reading level. It is designed to differentiate between the temporary condition of "state anxiety" and a long term personality trait. We will determine whether the subjects' perioperative glucose level correlates with the his/her score on the STAI.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New Jersey
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Newark, New Jersey, United States, 07101
- University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-diabetic preoperative fasting blood sugar level of 110 mg/dL or less.
Exclusion Criteria:
- Fasting blood sugar > than 110mg/dL
- Subjects who are pregnant
- Subjects who do not speak English
- Subjects who are on steroids prior to admission
- Hypersensitivity to midazolam
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
half of the patients will receive placebo (normal saline 2cc/) prior to entering the OR
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Normal saline 2cc.
one dose prior to OR
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Active Comparator: Midazolam
half of the patients will receive Midazolam 1-2.5mg prior to entering the OR
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1-2.5 mg
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements
Time Frame: every 30 min for duration of surgery
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Non diabetic subjects undergoing hernia repair were randomized into 2 groups.
Midazolam vs. placebo.
Blood glucose level was monitored preoperatively and following induction of anesthesia at 30 minute intervals perioperatively, and after in the PACU at 30 minutes and 60 minutes following arrival.
All readings were performed using the Abbott Freestyle Glucose Monitor.
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every 30 min for duration of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Level Percent Change From Pre-op to Maximum Glucose Level
Time Frame: Preoperatively, intraoperatively 30 min for duration of surgery
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blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min
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Preoperatively, intraoperatively 30 min for duration of surgery
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Percent Intra-op Blood Glucose Level of 140mg/dL or Less
Time Frame: perioperatively
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blood glucose level will be tested perioperatively at 30 minute intervals following induction.
All glucose levels will be recorded .midazolam group will maintain a blood glucose level perioperatively of 140mg/dL or less
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perioperatively
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Collaborators and Investigators
Investigators
- Principal Investigator: Vasanti Tilak, MD, UMDNJ/NJMS
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Hernia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
Other Study ID Numbers
- 0120110037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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