Pharmacodynamics of Nasal and Buccal Midazolam Using EEG (nMDZ-EEG)
|ClinicalTrials.gov Identifier: NCT01316445|
Recruitment Status : Terminated (Funding agency no longer provide support.)
First Posted : March 16, 2011
Last Update Posted : February 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: nasal Midazolam||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparing the Pharmacodynamics of Nasal and Buccal Midazolam Using EEG|
|Study Start Date :||July 2011|
|Primary Completion Date :||February 2014|
|Study Completion Date :||February 2014|
Experimental: nasal Midazolam
3 mg of the standard IV solution of midazolam (5 mg/mL) was given via a metered-dose nasal sprayer (6 sprays × 0.1 ml/spray, or 6 × 0.5 mg/spray) divided between the two nostrils within 1-2 min. During the EEG, vital signs (blood oxygen saturation, blood pressure, pulse and respiratory rate) were monitored and a nurse and a physician were available at all times. Subjects were monitored for 2 hours after administration of midazolam to ensure adequate recovery from sedation.
Drug: nasal Midazolam
Intranasal and buccal administration of the standard IV formulation of midazolam (5mg/mL), administered via a metered dose sprayer at 0.1mL/spray (i.e. 0.5mg/spray). Administration will be via three sprays in each nostril (for nasal) or three sprays between the cheek and the gum per side (for buccal).
Other Name: Versed
- 25% increase in total beta power for at least 1 minute at 10-30Hz [ Time Frame: for 30 mins after administration of drug ]Quantitative and qualitative visual EEG analysis for benzodiazepine-induced beta activity, total power of ~10-30 Hz activity
- beta activity at 10-12 Hz [ Time Frame: for 30 minutes after drug administration ]Qualitative visual and quantitative EEG analysis for benzodiazepine-induced beta activity at bands of 10-12 Hz
- beta activity at 30-40Hz [ Time Frame: for 30 minutes after drug administration ]Qualitative visual and quantitative EEG analysis for benzodiazepine-induced beta activity at bands of 30-40Hz.
- sedation [ Time Frame: for 30 minues after drug administration ]Subject perception of sedation will be evaluated using yes or no type questions, evaluation questions using a visual analogue scale (from 1 to 10) and open response questions.
- pain/discomfort [ Time Frame: for 30 minutes after drug administration ]Subject perception of discomfort will be evaluated using yes or no type questions, evaluation questions on a visual analogue scale (from 1 to 10), and open-response questions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316445
|United States, New York|
|Columbia University Medical Center, Milstein Hospital|
|New York, New York, United States, 10032|
|Principal Investigator:||Derek Chong, MD||Columbia University|