Trial Outcomes & Findings for Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication (NCT NCT01976845)

NCT ID: NCT01976845

Last Updated: 2016-03-14

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 139 participants
• Primary outcome timeframe: one day
• Results posted on: 2016-03-14

Participant Flow

Prior to the day of surgery, potential study patients received a packet of materials (initial patient contact letter, a HIPAA information sheet, and the IRB approved informed consent form) from their surgeon. Patients who were interested in participating in the study were asked to bring the materials to the hospital on the day of surgery.

Randomization assignment was generated with a 1:1:1 allocation ratio using a computer software program. The randomization number specifying the study medication was placed in sealed envelope and given to a non-participating anesthesiologist on the day of the scheduled procedure after completing the patient's preoperative assessment.

Participant milestones

Measure	Propofol Propofol 20 mg IV (2 ml) Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication	Midazolam Midazolam 2 mg IV (2 ml) Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication	Saline Saline 2 ml Saline: Saline 2 ml IV, in the pre-op area as a premedication
Overall Study STARTED	48	48	43
Overall Study COMPLETED	40	40	40
Overall Study NOT COMPLETED	8	8	3

Reasons for withdrawal

Measure	Propofol Propofol 20 mg IV (2 ml) Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication	Midazolam Midazolam 2 mg IV (2 ml) Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication	Saline Saline 2 ml Saline: Saline 2 ml IV, in the pre-op area as a premedication
Overall Study Physician Decision	8	8	3

Baseline Characteristics

Efficacy of Propofol or Midazolam Compare to Placebo for Preoperative Medication

Baseline characteristics by cohort

Measure	Propofol n=40 Participants Propofol 20 mg IV (2 ml) Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication	Midazolam n=40 Participants Midazolam 2 mg IV (2 ml) Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication	Saline n=40 Participants Saline 2 ml Saline: Saline 2 ml IV, in the pre-op area as a premedication	Total n=120 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 13 • n=5 Participants	51 years STANDARD_DEVIATION 15 • n=7 Participants	49 years STANDARD_DEVIATION 14 • n=5 Participants	51 years STANDARD_DEVIATION 14 • n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	64 Participants n=4 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	40 participants n=5 Participants	120 participants n=4 Participants
Body Mass Index (BMI)	28 kg^m2 STANDARD_DEVIATION 5 • n=5 Participants	28 kg^m2 STANDARD_DEVIATION 6 • n=7 Participants	28 kg^m2 STANDARD_DEVIATION 5 • n=5 Participants	28 kg^m2 STANDARD_DEVIATION 5 • n=4 Participants

PRIMARY outcome

Timeframe: one day

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

Outcome measures

Measure	Propofol n=40 Participants Propofol 20 mg IV (2 ml) Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication	Midazolam n=40 Participants Midazolam 2 mg IV (2 ml) Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication	Saline n=40 Participants Saline 2 ml Saline: Saline 2 ml IV, in the pre-op area as a premedication
Scores on the Verbal Rating Scale For Anxiety	1.8 Scores on a Scale (0-10) Standard Deviation 1.8	2.3 Scores on a Scale (0-10) Standard Deviation 2.1	2.8 Scores on a Scale (0-10) Standard Deviation 2.1

SECONDARY outcome

Timeframe: one day

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

Outcome measures

Measure	Propofol n=40 Participants Propofol 20 mg IV (2 ml) Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication	Midazolam n=40 Participants Midazolam 2 mg IV (2 ml) Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication	Saline n=40 Participants Saline 2 ml Saline: Saline 2 ml IV, in the pre-op area as a premedication
Scores on the Verbal Rating Scale For Sleepiness (Sedation)	4.6 Scores on a Scale (0-10) Standard Deviation 2.5	5.2 Scores on a Scale (0-10) Standard Deviation 2.3	2.5 Scores on a Scale (0-10) Standard Deviation 2.4

SECONDARY outcome

Timeframe: one day

Population: Subjects who recall the picture

Ability to recall (memory of):

•recall of 2 pictures

Outcome measures

Measure	Propofol n=40 Participants Propofol 20 mg IV (2 ml) Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication	Midazolam n=40 Participants Midazolam 2 mg IV (2 ml) Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication	Saline n=40 Participants Saline 2 ml Saline: Saline 2 ml IV, in the pre-op area as a premedication
Produces Amnesia(Memory Recall)	30 participants	12 participants	38 participants

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ronald H Wender

Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles

Phone: 3104231682

Email: ronald.wender@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place