Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | June 2011 |
End Date: | August 2012 |
Does the Administration of Preop Midazolam Assist in Maintaining Blood Glucose Norms in Non-diabetic Patient During the Perioperative Period
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.
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 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.
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.
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
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