Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01641653
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : November 7, 2014
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Brief 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.

Condition or disease Intervention/treatment Phase
Hernia Other: Normal saline Drug: Midazolam Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : June 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar Hernia

Arm Intervention/treatment
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
Drug: Midazolam
1-2.5 mg
Other Name: Versed

Primary Outcome Measures :
  1. Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements [ Time Frame: every 30 min for duration of surgery ]
    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.

Secondary Outcome Measures :
  1. Glucose Level Percent Change From Pre-op to Maximum Glucose Level [ Time Frame: Preoperatively, intraoperatively 30 min for duration of surgery ]
    blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min

  2. Percent Intra-op Blood Glucose Level of 140mg/dL or Less [ Time Frame: perioperatively ]
    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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01641653

United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Principal Investigator: Vasanti Tilak, MD UMDNJ/NJMS

Responsible Party: University of Medicine and Dentistry of New Jersey Identifier: NCT01641653     History of Changes
Other Study ID Numbers: 0120110037
First Posted: July 17, 2012    Key Record Dates
Results First Posted: November 7, 2014
Last Update Posted: November 2, 2016
Last Verified: November 2014

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
Nondiabetics undergoing hernia repair.

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action