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

Primary Purpose

Hernia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Normal saline
Midazolam
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia focused on measuring Nondiabetics undergoing hernia repair.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

Midazolam

Arm Description

half of the patients will receive placebo (normal saline 2cc/) prior to entering the OR

half of the patients will receive Midazolam 1-2.5mg prior to entering the OR

Outcomes

Primary Outcome Measures

Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements
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

Glucose Level Percent Change From Pre-op to Maximum Glucose Level
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
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

Full Information

First Posted
December 8, 2011
Last Updated
September 27, 2016
Sponsor
University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01641653
Brief Title
Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period
Official Title
Does the Administration of Preop Midazolam Assist in Maintaining Blood Glucose Norms in Non-diabetic Patient During the Perioperative Period
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Medicine and Dentistry of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia
Keywords
Nondiabetics undergoing hernia repair.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
half of the patients will receive placebo (normal saline 2cc/) prior to entering the OR
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
half of the patients will receive Midazolam 1-2.5mg prior to entering the OR
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Normal saline 2cc. one dose prior to OR
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
1-2.5 mg
Primary Outcome Measure Information:
Title
Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements
Description
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.
Time Frame
every 30 min for duration of surgery
Secondary Outcome Measure Information:
Title
Glucose Level Percent Change From Pre-op to Maximum Glucose Level
Description
blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min
Time Frame
Preoperatively, intraoperatively 30 min for duration of surgery
Title
Percent Intra-op Blood Glucose Level of 140mg/dL or Less
Description
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
Time Frame
perioperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasanti Tilak, MD
Organizational Affiliation
UMDNJ/NJMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States

12. IPD Sharing Statement

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

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