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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01641653
First received: December 8, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention
Hernia
Other: Normal saline
Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Does the Administration of Preop Midazolam Assist in Maintaining Blood Glucose Norms in Non-diabetic Patient During the Perioperative Period

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • maximum perioperative blood glucose level [ Time Frame: Perioperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess subjects state of anxiety prior to administration of drug or placebo [ Time Frame: Preoperatively ] [ Designated as safety issue: No ]
    State Trait Anxiety Inventory for adults Form Y-01 and Form Y-2


Enrollment: 60
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: maxium intraoperative glucose level
half of the patients will receive placebo prior to entering the OR
Other: Normal saline
Normal saline 2cc. one dose prior to OR
Active Comparator: maximum glucose level intraoperatively
half of the patients will receive Midazolam prior to entering the OR
Drug: Midazolam
1-2.5 mg
Other Name: Versed

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01641653

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

No publications provided

Responsible Party: Anesthesia, Department of Anesthesia Investigator initiated, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01641653     History of Changes
Other Study ID Numbers: 0120110037
Study First Received: December 8, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Nondiabetics undergoing hernia repair.

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

ClinicalTrials.gov processed this record on July 20, 2014