NCT03246724 - Oral Versus Intravenous Sedation for Ocular Procedures | Biotech Hunter

Enrollment

327

Participants

Timeline

Start Date

October 16, 2017

Primary Completion Date

November 30, 2019

Study Completion Date

November 30, 2019

Conditions

SurgerySedation

Interventions

DRUG

Triazolam

"This will be used for oral sedation. This capsule or a microcrystalline cellulose placebo capsule will be administered depending on the randomized treatment group.~Dose for BMI less than 35: 0.125 mg~Dose for BMI greater than or equal to 35: 0.25 mg"

DRUG

Midazolam

"This will be used for intravenous sedation. This injection or sodium chloride 0.9% will be administered depending on the randomized treatment group.~Dose for BMI less than 35: 1.0 mg~Dose for BMI greater than or equal to 35: 2.0 mg"

DRUG

Microcrystalline Cellulose

"This will be used for the oral placebo. This capsule or a triazolam capsule will be administered depending on the randomized treatment group.~Dose for BMI less than 35: 1 capsule~Dose for BMI greater than or equal to 35: 2 capsule"

DRUG

Sodium chloride 0.9%

"This will be used for the intravenous placebo.This injection or midazolam will be administered depending on the randomized treatment group.~Dose for BMI less than 35: volume to match volume of active intravenous medication~Dose for BMI greater than or equal to 35: volume to match volume of active intravenous medication"

Trial Locations (1)

02118

Boston Medical Center, Boston