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

NCT01641653 | Completed Phase 4 Results

• 1 other identifier: 0120110037
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia

Keywords

Nondiabetics undergoing hernia repair.

Outcome Measures

Primary Outcomes (1)

• 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.

  every 30 min for duration of surgery

Secondary Outcomes (2)

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

  Preoperatively, intraoperatively 30 min for duration of surgery

• Percent Intra-op Blood Glucose Level of 140mg/dL or Less

  perioperatively

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Other: Normal saline

Midazolam

ACTIVE COMPARATOR

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

Drug: Midazolam

Interventions

Normal saline OTHER

Normal saline 2cc. one dose prior to OR

placebo

Midazolam DRUG

1-2.5 mg

Also known as: Versed

Midazolam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-diabetic preoperative fasting blood sugar level of 110 mg/dL or less.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Hernia

Interventions

Saline Solution; Midazolam

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Vasanti Tilak, MD
• Organization: Rutgers-New Jersey Medical School

tilakva@njms.rutgers.edu

973 972-7477

Study Officials

• Vasanti Tilak, MD

  UMDNJ/NJMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: July 17, 2012
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 2, 2016
• Results First Posted: November 7, 2014

Record last verified: 2014-11

Locations

US (1)