43
Participants
Start Date
February 28, 2015
Primary Completion Date
February 28, 2018
Study Completion Date
February 28, 2018
Nitrous Oxide arm
Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
Propofol
The loading dose of propofol will be administered immediately after nitrous oxide discontinuation. All sedations in this trial will use propofol 1.0 mg/Kg initial dose, with 0.5 mg/Kg doses titrated to deep sedation. Once the patient is deeply sedated, the procedure will begin.
Oxygen
If pulse oximetry declines to less than 92%, subject will be placed on nasal cannula with administration of 2 liter flow of oxygen and titrated in increments of 1 L flow to maintain pulse oximetry greater than 92%
Albert Einstein Medical Center, Philadelphia
Albert Einstein Healthcare Network
OTHER