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Elective Orthopedic Surgery | Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication

Elective Orthopedic Surgery research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Willingness and ability to sign an informed consent document - No allergies to midazolam or propofol - 18 - 70 years of age - American Society of Anesthesiologists (ASA) Class I-III adults of either sex Exclusion Criteria: - Patients with known allergy, hypersensitivity or contraindications to midazolam, propofol, anesthetic or analgesic medications - Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases - Pregnant or lactating women - Subjects with a history of alcohol or drug abuse within the past 3 months - Patients chronically using sedative, anxiolytic drugs prior to the surgery - Morbid obesity (BMI >40 kg/m2) - Patients who are agitated or confused prior to receiving the drug ( verbal rating scale [VRS] greater then 6)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Elective Orthopedic Surgery

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Drug:SalineSaline 2 ml IV, in the pre-op area as a premedication

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PropofolPropofol 20 mg IV (2 ml)

MidazolamMidazolam 2 mg IV (2 ml)

SalineSaline 2 ml

Study Status

Completed

Start Date: November 2013

Completed Date: July 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Scores on the Verbal Rating Scale For Anxiety

Secondary Outcome: Scores on the Verbal Rating Scale For Sleepiness (Sedation)

Study sponsors, principal investigator, and references

Principal Investigator: Ronald H Wender, MD

Lead Sponsor: Cedars-Sinai Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01976845

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