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Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication

NCT01976845 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2016-03-14

Study results available
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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.

Conditions

  • Elective Orthopedic Surgery

Interventions

DRUG

Midazolam

Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication

DRUG

Propofol

Propofol (20mg) 2 ml IV, in the pre-op area as a premedication

DRUG

Saline

Saline 2 ml IV, in the pre-op area as a premedication

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Ronald H Wender, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976845 on ClinicalTrials.gov