Phase 4 N=139 Randomized Quadruple-blind Prevention

Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication

Elective Orthopedic Surgery

Bottom Line

View on ClinicalTrials.gov: NCT01976845 ↗

Enrolled (actual)

139

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Scores on the Verbal Rating Scale For Anxiety — 1.8; 2.3; 2.8 Scores on a Scale (0-10)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Midazolam (Drug); Propofol (Drug); Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cedars-Sinai Medical Center
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Scores on the Verbal Rating Scale For Anxiety	1.8; 2.3; 2.8	—
SECONDARY Scores on the Verbal Rating Scale For Sleepiness (Sedation)	4.6; 5.2; 2.5	—
SECONDARY Produces Amnesia(Memory Recall)	30; 12; 38	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01976845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.