Phase 4
Completed N=139
Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication
Elective Orthopedic Surgery
Source: ClinicalTrials.gov NCT01976845 ↗
Enrolled (actual)
139
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Scores on the Verbal Rating Scale For Anxiety — 1.8; 2.3; 2.8 Scores on a Scale (0-10)
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.
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 | — |
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)
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. Informational only — not medical advice.