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This research is being done to investigate if patients who receive a commonly used sedative drug, known as midazolam, are likely to have high blood sugar levels during the stressful period during and immediately after surgery. A sedative drug is used to relax a person without making them sleepy. This drug is also helpful in reducing the memory of the stressful experience before the anesthesiologists administers anesthesia. Everyone has glucose or sugar in their blood stream. This sugar gives energy to our organs to allow them to work. Since high blood sugar levels may be associated with complications like wound infections, the investigators research is being done to find if patients who receive a sedative medication prior to their surgical procedure have lower blood sugars during the surgery then a patient who does not receive the sedation. The investigators would like to know if the administration of this commonly used drug will help patients maintain a normal glucose level during a stressful period.
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 Freestyleâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | half of the patients will receive placebo (normal saline 2cc/) prior to entering the OR |
|
| Midazolam | Active Comparator | half of the patients will receive Midazolam 1-2.5mg prior to entering the OR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Other | Normal saline 2cc. one dose prior to OR |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements | 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. | every 30 min for duration of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Level Percent Change From Pre-op to Maximum Glucose Level | blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min | Preoperatively, intraoperatively 30 min for duration of surgery |
| Percent Intra-op Blood Glucose Level of 140mg/dL or Less |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vasanti Tilak, MD | UMDNJ/NJMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Newark | New Jersey | 07101 | United States |
Non diabetics with fasting blood sugar < = to 110mg/dL scheduled for an elective hernia repair
6/21/11-8/9/12 preoperative holding area
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | half of the patients will receive placebo (normal saline 2mL) prior to entering the OR Normal saline: Normal saline 2cc. one dose prior to OR |
| FG001 | Midazolam | half of the patients will receive Midazolam prior to entering the OR Midazolam: 1-2.5 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
non diabetics undergoing hernia repair
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | half of the patients will receive placebo (normal saline) prior to entering the OR Normal saline: Normal saline 2cc. one dose prior to OR |
| BG001 | Midazolam | half of the patients will receive Midazolam prior to entering the OR Midazolam: 1-2.5 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements | 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. | per protocol | Posted | Median | Inter-Quartile Range | mg/dL | every 30 min for duration of surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | half of the patients will receive placebo (normal saline) prior to entering the OR Normal saline: Normal saline 2cc. one dose prior to OR |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vasanti Tilak, MD | Rutgers-New Jersey Medical School | 973 972-7477 | tilakva@njms.rutgers.edu |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Midazolam |
| Drug |
1-2.5 mg |
|
|
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 |
| perioperatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | participants scheduled for hernia repair were screened and consented, preoperative glucose level was then performed with Abbott Freestyle monitor to insure that fasting glucose level was below or equal to 110mg/dL. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
One half of subjects will recieveMidazolam: 1-2.5 mg IV
|
|
|
| Secondary | Glucose Level Percent Change From Pre-op to Maximum Glucose Level | blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min | per protocol | Posted | Median | Inter-Quartile Range | percentage of increase in glucose level | Preoperatively, intraoperatively 30 min for duration of surgery |
|
|
|
|
| Secondary | Percent Intra-op Blood Glucose Level of 140mg/dL or Less | 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 | Posted | Number | percentage of glucose levels<140 | perioperatively |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Midazolam | half of the patients will receive Midazolam prior to entering the OR Midazolam: 1-2.5 mg | 0 | 30 | 0 | 30 |
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| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |