At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Propofol or Midazolam Versus Placebo for Preoperative Medication in Patients Undergoing Elective Orthopedic Surgery
In Brief
A Phase 4 clinical trial evaluating Midazolam, Propofol, and 1 other intervention for Elective Orthopedic Surgery. Completed, enrolled 139 participants across 1 site.
Detailed Summary
The purpose of this research is: To evaluate the sedative (reduces irritability or agitation), anxiolytic (reduces anxiety), and amnesic (produces temporary lack of recall) effects of propofol or midazolam when administered for preoperative medication (before administration of drugs that will put patient to sleep) in comparison to placebo. This study is to test whether the use of the pre-anesthesia medication measurably reduces anxiety in comparison to receiving no pre-anesthesia medication prior to orthopedic procedures. To assess the effect of propofol in comparison to placebo and midazolam on the ability to recall (memory of): * when the doctor places the mask on patient's face prior to going to sleep * recall of 2 pictures * on your satisfaction with the anesthesia as well as postoperative side effects in post-anesthesia care unit (PACU) e.g., nausea ,vomiting and sedation.
Study Details
Timeline
Interventions
Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication
Propofol (20mg) 2 ml IV, in the pre-op area as a premedication
Saline 2 ml IV, in the pre-op area as a premedication