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

Does the Administration of Preop Midazolam Assist in Maintaining Blood Glucose Norms in Non-diabetic Patient During the Perioperative Period

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01641653
Enrollment
60
Registered
2012-07-17
Start date
2011-06-30
Completion date
2012-08-31
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia

Keywords

Nondiabetics undergoing hernia repair.

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.

Interventions

OTHERNormal saline

Normal saline 2cc. one dose prior to OR

DRUGMidazolam

1-2.5 mg

Sponsors

University of Medicine and Dentistry of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurementsevery 30 min for duration of surgeryNon 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

MeasureTime frameDescription
Glucose Level Percent Change From Pre-op to Maximum Glucose LevelPreoperatively, intraoperatively 30 min for duration of surgeryblood 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 Lessperioperativelyblood 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

Countries

United States

Participant flow

Recruitment details

6/21/11-8/9/12 preoperative holding area

Pre-assignment details

Non diabetics with fasting blood sugar \< = to 110mg/dL scheduled for an elective hernia repair

Participants by arm

ArmCount
Placebo
half of the patients will receive placebo (normal saline) prior to entering the OR Normal saline: Normal saline 2cc. one dose prior to OR
30
Midazolam
half of the patients will receive Midazolam prior to entering the OR Midazolam: 1-2.5 mg
30
Total60

Baseline characteristics

CharacteristicPlaceboMidazolamTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants1 Participants2 Participants
Age, Categorical
Between 18 and 65 years
29 Participants29 Participants58 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants12 Participants25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants14 Participants25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants4 Participants10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
13 Participants11 Participants24 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants4 Participants10 Participants
Race (NIH/OMB)
White
9 Participants12 Participants21 Participants
Region of Enrollment
United States
30 participants30 participants60 participants
Sex: Female, Male
Female
9 Participants13 Participants22 Participants
Sex: Female, Male
Male
21 Participants17 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

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.

Time frame: every 30 min for duration of surgery

Population: per protocol

ArmMeasureValue (MEDIAN)
PlaceboMaximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements114.0 mg/dL
MidazolamMaximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements108.0 mg/dL
Comparison: This is a pilot study no power calculation was performed. The Wilcoxon rank-sum test was used to assess differences in max intraop glucose between placebo and midazolam groups.p-value: 0.87Wilcoxon (Mann-Whitney)
Secondary

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

Time frame: Preoperatively, intraoperatively 30 min for duration of surgery

Population: per protocol

ArmMeasureValue (MEDIAN)
PlaceboGlucose Level Percent Change From Pre-op to Maximum Glucose Level24.9 percentage of increase in glucose level
MidazolamGlucose Level Percent Change From Pre-op to Maximum Glucose Level14.9 percentage of increase in glucose level
Comparison: percent change in glucose levels from preoperative level to maximum perioperative measurement levelp-value: 0.56Wilcoxon (Mann-Whitney)
Secondary

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

Time frame: perioperatively

ArmMeasureValue (NUMBER)
PlaceboPercent Intra-op Blood Glucose Level of 140mg/dL or Less100 percentage of glucose levels<140
MidazolamPercent Intra-op Blood Glucose Level of 140mg/dL or Less86.6 percentage of glucose levels<140
p-value: 0.12Chi-squared, Corrected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026