Pharmacodynamics of Nasal and Buccal Midazolam Using EEG (nMDZ-EEG)
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|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|
|Actual Primary Completion Date :||February 2014|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|