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NCT01641653 · ClinicalTrials.gov registry record · Phase 4
Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period
A Phase 4 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01641653: Completed Phase 4 study, sponsored by University of Medicine and Dentistry of New Jersey.
NCT01641653 is a Phase 4 study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01641653, a Phase 4 study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Midazolam
- OTHER Normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
What the finished NCT01641653 record still lists
NCT01641653 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT01641653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01641653 about?
NCT01641653 is a clinical study titled "Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period". 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. Thi...
What is the current status of trial NCT01641653?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2011-06. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01641653?
The interventions under investigation include: Midazolam (DRUG), Normal saline (OTHER).
Who is sponsoring clinical trial NCT01641653?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01641653's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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