Procedural Sedation
Conditions
Keywords
Deep Procedural Sedation, Propofol, Ketamine, Emergency Department, Monitoring, Capnography, Procedural Sedation in the Emergency Department
Brief summary
This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided. In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.
Interventions
DRUGPropofol
1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
DRUG1:1 Propofol/Ketamine
Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
DRUG4:1 Propofol/Ketamine
Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
Sponsors
Hennepin Healthcare Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing procedural sedation for an urgent procedure in the Emergency Department
Exclusion criteria
* Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical status score \>2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Interventions During Sedation | From start of sedation procedure to end of sedation procedure, up to 24 hours | Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation |
| Hypoxia | From start of sedation procedure to end of sedation procedure, up to 24 hours | Pulse oximetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Depression | From start of sedation procedure to end of sedation procedure, up to 24 hours | Continuous capnographic monitoring |
| Procedural Recall | Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion. | 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. |
Countries
United States
Participant flow
Recruitment details
300 patients recruited in the Emergency Department from October 24, 2010 to February 4, 2013
Pre-assignment details
271 enrolled subjects underwent procedural sedation
Participants by arm
| Arm | Count |
|---|---|
| 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 | 90 |
| 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 | 85 |
| 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 | 96 |
| Total | 271 |
Baseline characteristics
| Characteristic | Propofol | 1:1 Propofol/Ketamine | 4:1 Propofol/Ketamine | Total |
|---|---|---|---|---|
| Age, Continuous | 40 years | 39 years | 36 years | 38 years |
| Region of Enrollment United States | 90 participants | 85 participants | 96 participants | 271 participants |
| Sex: Female, Male Female | 43 Participants | 40 Participants | 45 Participants | 128 Participants |
| Sex: Female, Male Male | 47 Participants | 45 Participants | 51 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 90 | 0 / 85 | 0 / 96 |
| serious Total, serious adverse events | 0 / 90 | 0 / 85 | 0 / 96 |
Outcome results
Primary
Clinical Interventions During Sedation
Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Clinical Interventions During Sedation | 41 Clinical interventions performed |
| 1:1 Propofol/Ketamine | Clinical Interventions During Sedation | 33 Clinical interventions performed |
| 4:1 Propofol/Ketamine | Clinical Interventions During Sedation | 48 Clinical interventions performed |
Primary
Hypoxia
Pulse oximetry
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Hypoxia | 11 Patients which experienced hypoxia |
| 1:1 Propofol/Ketamine | Hypoxia | 6 Patients which experienced hypoxia |
| 4:1 Propofol/Ketamine | Hypoxia | 18 Patients which experienced hypoxia |
Secondary
Procedural Recall
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Procedural Recall | 6 percentage report recall of procedure |
| 1:1 Propofol/Ketamine | Procedural Recall | 14 percentage report recall of procedure |
| 4:1 Propofol/Ketamine | Procedural Recall | 11 percentage report recall of procedure |
Secondary
Respiratory Depression
Continuous capnographic monitoring
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Respiratory Depression | 15 number of respiratory depression events |
| 1:1 Propofol/Ketamine | Respiratory Depression | 16 number of respiratory depression events |
| 4:1 Propofol/Ketamine | Respiratory Depression | 21 number of respiratory depression events |