Trial Outcomes & Findings for Does Preop Midazolam Maintain Blood Glucose Norms in the Non Diabetic Perioperative Period (NCT NCT01641653)

Last Updated: 2016-11-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

every 30 min for duration of surgery

Results posted on

2016-11-02

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Placebo half of the patients will receive placebo (normal saline 2mL) prior to entering the OR Normal saline: Normal saline 2cc. one dose prior to OR	Midazolam half of the patients will receive Midazolam prior to entering the OR Midazolam: 1-2.5 mg
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=30 Participants half of the patients will receive placebo (normal saline) prior to entering the OR Normal saline: Normal saline 2cc. one dose prior to OR	Midazolam n=30 Participants half of the patients will receive Midazolam prior to entering the OR Midazolam: 1-2.5 mg	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: every 30 min for duration of surgery

Population: per protocol

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Normal saline: Normal saline 2cc. IV one dose prior to OR	Midazolam n=30 Participants One half of subjects will recieveMidazolam: 1-2.5 mg IV
Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements	114.0 mg/dL Interval 101.0 to 126.0	108.0 mg/dL Interval 101.0 to 125.0

SECONDARY outcome

Timeframe: Preoperatively, intraoperatively 30 min for duration of surgery

Population: per protocol

blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Normal saline: Normal saline 2cc. IV one dose prior to OR	Midazolam n=30 Participants One half of subjects will recieveMidazolam: 1-2.5 mg IV
Glucose Level Percent Change From Pre-op to Maximum Glucose Level	24.9 percentage of increase in glucose level Interval 10.99 to 38.1	14.9 percentage of increase in glucose level Interval 7.69 to 37.5

SECONDARY outcome

Timeframe: perioperatively

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

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Normal saline: Normal saline 2cc. IV one dose prior to OR	Midazolam n=26 Participants One half of subjects will recieveMidazolam: 1-2.5 mg IV
Percent Intra-op Blood Glucose Level of 140mg/dL or Less	100 percentage of glucose levels<140	86.6 percentage of glucose levels<140

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vasanti Tilak, MD

Rutgers-New Jersey Medical School

Phone: 973 972-7477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place