Trial Outcomes & Findings for Stress During Deep Sedation With Propofol With and Without Alfentanil (NCT NCT00997113)

Results Overview

change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes

Results posted on

2014-09-25

Participant Flow

34 patients were elligible, 14 underwent sedation emergently before the patient could be approached for study enrollment.

Participant milestones

Participant milestones
Measure	Propofol propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation	Propofol/Alfentanil Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stress During Deep Sedation With Propofol With and Without Alfentanil

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol n=10 Participants propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation	Propofol/Alfentanil n=10 Participants Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose	Total n=20 Participants Total of all reporting groups
Age, Continuous	34 years n=99 Participants	36 years n=107 Participants	35 years n=206 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	4 Participants n=107 Participants	10 Participants n=206 Participants
Region of Enrollment United States	10 participants n=99 Participants	10 participants n=107 Participants	20 participants n=206 Participants

PRIMARY outcome

Timeframe: one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes

change in serum catecholamine levels, values indicate a decrease over the procedure. These patients underwent fracture reduction procedures which are typically associated with an increase in catecholamines.

Outcome measures

Outcome measures
Measure	Propofol n=10 Participants propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation	Propofol/Alfentanil n=10 Participants Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose
Change in Serum Catecholamines	87 mcg/ml Interval 1.0 to 353.0	106 mcg/ml Interval 21.0 to 295.0

SECONDARY outcome

Timeframe: From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status

categorized as a change in end tidal CO2 from baseline \>10mmhg, a loss of end tidal CO2 waveform for more than 6 seconds, or an oxygen saturation less than 93%.

Outcome measures

Outcome measures
Measure	Propofol n=10 Participants propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation	Propofol/Alfentanil n=10 Participants Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose
Respiratory Depression	4 participants	5 participants

SECONDARY outcome

Timeframe: single time point measured after sedation procedure completed

Pain and recall were measured seperately by direct patient query. The patient was asked if they experienced any pain during the procedure. The patient was then asked if they could recall any part of the fracture reduction. Patients who had either pain with the procedure of recall of the procedure were counted as having pain or recall with the procedure.

Outcome measures

Outcome measures
Measure	Propofol n=10 Participants propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation	Propofol/Alfentanil n=10 Participants Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose
Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure	2 participants	5 participants

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol/Alfentanil

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Propofol n=10 participants at risk propofol only for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation	Propofol/Alfentanil n=10 participants at risk Propofol with alfentanil for deep procedural sedation propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose
Respiratory, thoracic and mediastinal disorders apnea	0.00% 0/10	10.0% 1/10 • Number of events 1

Additional Information

James Miner

Minneapolis Medical Reseach Foundation

Phone: 6128738791

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place