Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period
Condition: Hernia
MeSH terms: Hernia
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

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.
    

Intervention name(s): Normal saline; Midazolam
Intervention type(s): Other; Drug
Intervention description(s): Normal saline 2cc. one dose prior to OR; 1-2.5 mg
Other intervention name(s): Versed
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Nondiabetics undergoing hernia repair.