Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication

NCT01976845 | Completed Phase 4 Results

• 1 other identifier: Pro00025204
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

propofol; midazolam; sedative; anxiolytic; amnesic; recall; Memory; Perioperative outcomes

Outcome Measures

Primary Outcomes (1)

• Scores on the Verbal Rating Scale For Anxiety

  Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely nervous)

  one day

Secondary Outcomes (2)

• Scores on the Verbal Rating Scale For Sleepiness (Sedation)

  one day

• Produces Amnesia(Memory Recall)

  one day

Study Arms (3)

Propofol

EXPERIMENTAL

Propofol 20 mg IV (2 ml)

Drug: Propofol

Midazolam

ACTIVE COMPARATOR

Midazolam 2 mg IV (2 ml)

Drug: Midazolam

Saline

PLACEBO COMPARATOR

Saline 2 ml

Drug: Saline

Interventions

Midazolam DRUG

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

Also known as: VERSED

Midazolam

Propofol DRUG

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

Also known as: Diprivan

Propofol

Saline DRUG

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

Also known as: Saline solution

Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to sign an informed consent document
• No allergies to midazolam or propofol
• years of age
• American Society of Anesthesiologists (ASA) Class I-III adults of either sex

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

Midazolam; Propofol; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Ronald H Wender
• Organization: Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles

ronald.wender@cshs.org

3104231682

Study Officials

• Ronald H Wender, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of anesthesiology

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)