Trial Outcomes & Findings for Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation (NCT NCT00997126)

NCT ID: NCT00997126

Last Updated: 2017-01-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 126 participants
• Primary outcome timeframe: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)
• Results posted on: 2017-01-27

Participant Flow

Participant milestones

Measure	Propofol Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Overall Study STARTED	63	63
Overall Study COMPLETED	56	52
Overall Study NOT COMPLETED	7	11

Reasons for withdrawal

Measure	Propofol Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Overall Study Physician Decision	7	11

Baseline Characteristics

Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

Baseline characteristics by cohort

Measure	Propofol n=56 Participants Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil n=52 Participants Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation	Total n=108 Participants Total of all reporting groups
Age, Continuous	36 years n=5 Participants	32 years n=7 Participants	34 years n=5 Participants
Gender Female	31 Participants n=5 Participants	23 Participants n=7 Participants	54 Participants n=5 Participants
Gender Male	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)

Outcome measures

Measure	Propofol n=56 Participants Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil n=52 Participants Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure	11 participants	12 participants

SECONDARY outcome

Timeframe: Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours

Outcome measures

Measure	Propofol n=56 Participants Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil n=52 Participants Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Time to Return of Baseline Mental Status From Start of Procedure in Minutes	13 minutes Interval 9.0 to 17.0	13 minutes Interval 10.0 to 17.0

SECONDARY outcome

Timeframe: Single measurement during sedation procedure

Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli

Outcome measures

Measure	Propofol n=56 Participants Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil n=52 Participants Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Depth of Sedation Measured Using the OAAS Scale	2 units on a scale Interval 1.0 to 3.0	3 units on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: Single measurement immediately after patient returns to baseline mental status after sedation procedure

Outcome measures

Measure	Propofol n=56 Participants Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil n=52 Participants Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Patient Reported Pain	7 participants	25 participants

SECONDARY outcome

Timeframe: Single measurement immediately after patient returns to baseline mental status after sedation procedure

Outcome measures

Measure	Propofol n=56 Participants Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil n=52 Participants Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Patient Reported Recall of the Procedure	13 participants	39 participants

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Alfentanil

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Propofol n=56 participants at risk Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation	Alfentanil n=52 participants at risk Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Respiratory, thoracic and mediastinal disorders any airway or respiratory adverse event	44.6% 25/56 • Number of events 30 • From 1 minute prior to the procedure until the patient returned to baseline mental status	55.8% 29/52 • Number of events 35 • From 1 minute prior to the procedure until the patient returned to baseline mental status

Additional Information

James Miner

MinneapolisMRF

Phone: 6128732493

Email: miner015@umn.edu

Results disclosure agreements

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