Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Does the Administration of Preop Midazolam Assist in Maintaining Blood Glucose Norms in Non-diabetic Patient During the Perioperative Period|
- Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements [ Time Frame: every 30 min for duration of surgery ] [ Designated as safety issue: No ]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.
- Glucose Level Percent Change From Pre-op to Maximum Glucose Level [ Time Frame: Preoperatively, intraoperatively 30 min for duration of surgery ] [ Designated as safety issue: No ]blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min
- Percent Intra-op Blood Glucose Level of 140mg/dL or Less [ Time Frame: perioperatively ] [ Designated as safety issue: No ]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
|Study Start Date:||June 2011|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
half of the patients will receive placebo (normal saline 2cc/) prior to entering the OR
Other: Normal saline
Normal saline 2cc. one dose prior to OR
Active Comparator: Midazolam
half of the patients will receive Midazolam 1-2.5mg prior to entering the OR
Other Name: Versed
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641653
|United States, New Jersey|
|Newark, New Jersey, United States, 07101|
|Principal Investigator:||Vasanti Tilak, MD||UMDNJ/NJMS|