Trial Outcomes & Findings for Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation (NCT NCT01260662)

Results Overview

Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

271 participants

Primary outcome timeframe

From start of sedation procedure to end of sedation procedure, up to 24 hours

Results posted on

2015-07-14

Participant Flow

300 patients recruited in the Emergency Department from October 24, 2010 to February 4, 2013

271 enrolled subjects underwent procedural sedation

Participant milestones

Participant milestones
Measure	Propofol Deep sedation using propofol (10 mg /mL) Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	1:1 Propofol/Ketamine Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	4:1 Propofol/Ketamine Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation
Overall Study STARTED	90	85	96
Overall Study COMPLETED	90	85	96
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Propofol n=90 Participants Deep sedation using propofol (10 mg /mL) Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	1:1 Propofol/Ketamine n=85 Participants Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	4:1 Propofol/Ketamine n=96 Participants Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	Total n=271 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	39 years n=7 Participants	36 years n=5 Participants	38 years n=4 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	40 Participants n=7 Participants	45 Participants n=5 Participants	128 Participants n=4 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	45 Participants n=7 Participants	51 Participants n=5 Participants	143 Participants n=4 Participants
Region of Enrollment United States	90 participants n=5 Participants	85 participants n=7 Participants	96 participants n=5 Participants	271 participants n=4 Participants

PRIMARY outcome

Timeframe: From start of sedation procedure to end of sedation procedure, up to 24 hours

Population: 100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm

Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation

Outcome measures

Outcome measures
Measure	Propofol n=90 Participants Deep sedation using propofol (10 mg /mL) Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	1:1 Propofol/Ketamine n=85 Participants Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	4:1 Propofol/Ketamine n=96 Participants Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation
Clinical Interventions During Sedation	41 Clinical interventions performed	33 Clinical interventions performed	48 Clinical interventions performed

PRIMARY outcome

Timeframe: From start of sedation procedure to end of sedation procedure, up to 24 hours

Population: 100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm

Pulse oximetry

Outcome measures

Outcome measures
Measure	Propofol n=90 Participants Deep sedation using propofol (10 mg /mL) Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	1:1 Propofol/Ketamine n=85 Participants Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	4:1 Propofol/Ketamine n=96 Participants Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation
Hypoxia	11 Patients which experienced hypoxia	6 Patients which experienced hypoxia	18 Patients which experienced hypoxia

SECONDARY outcome

Timeframe: From start of sedation procedure to end of sedation procedure, up to 24 hours

Population: 100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm

Continuous capnographic monitoring

Outcome measures

Outcome measures
Measure	Propofol n=90 Participants Deep sedation using propofol (10 mg /mL) Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	1:1 Propofol/Ketamine n=85 Participants Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	4:1 Propofol/Ketamine n=96 Participants Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation
Respiratory Depression	15 number of respiratory depression events	16 number of respiratory depression events	21 number of respiratory depression events

SECONDARY outcome

Timeframe: Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.

Population: 100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm

After patients returned to baseline mental status they were asked whether they were able to recall any of the procedure. Question was answered in a yes or no format.

Outcome measures

Outcome measures
Measure	Propofol n=90 Participants Deep sedation using propofol (10 mg /mL) Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	1:1 Propofol/Ketamine n=85 Participants Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation	4:1 Propofol/Ketamine n=96 Participants Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL) Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation
Procedural Recall	6 percentage report recall of procedure	14 percentage report recall of procedure	11 percentage report recall of procedure

Adverse Events

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1:1 Propofol/Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4:1 Propofol/Ketamine

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

James Miner

MinneapolisMRF

Phone: 612-873-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place