drugset / Trial / NCT01976845

Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication

NCT01976845 ↗

Phase 4 Completed 139 enrolled Cedars-Sinai Medical Center
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2013-11
Primary completion
2015-07
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 2 mg Intravenous
Subject Propofol Small molecule 20 mg Intravenous

Indications

No indication recorded.