Phase 4
N=60
Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period
Hernia
Bottom Line
View on ClinicalTrials.gov: NCT01641653 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements — 114.0; 108.0 mg/dL — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Normal saline (Other); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Medicine and Dentistry of New Jersey
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements |
114.0; 108.0 | 0.87 |
| SECONDARY Glucose Level Percent Change From Pre-op to Maximum Glucose Level |
24.9; 14.9 | 0.56 |
| SECONDARY Percent Intra-op Blood Glucose Level of 140mg/dL or Less |
100; 86.6 | 0.12 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01641653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.