Trial Outcomes & Findings for Ketamine and Propofol for Upper Endoscopy (NCT NCT02295553)
NCT ID: NCT02295553
Last Updated: 2019-06-10
Results Overview
The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0, 0.25, 0.5 and 1 mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on endoscope insertion in children
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
56 participants
Primary outcome timeframe
This outcome is measured at the time of insertion of the endoscope into the esophagus.
Results posted on
2019-06-10
Participant Flow
Participant milestones
| Measure |
Ketamine 0 mg/kg
Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
Propofol
|
Ketamine 0.25 mg/kg
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 0.5 mg/kg
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 1.0 mg/kg
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine and Propofol for Upper Endoscopy
Baseline characteristics by cohort
| Measure |
Ketamine 0 mg/kg
n=14 Participants
Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
Propofol
|
Ketamine 0.25 mg/kg
n=14 Participants
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 0.5 mg/kg
n=13 Participants
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 1.0 mg/kg
n=14 Participants
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.4 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
8.9 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
8.9 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
8.9 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
8.8 years
STANDARD_DEVIATION 2.5 • n=21 Participants
|
|
Sex/Gender, Customized
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
|
Weight
|
30.1 kg
STANDARD_DEVIATION 12.4 • n=5 Participants
|
28.5 kg
STANDARD_DEVIATION 8.9 • n=7 Participants
|
29.5 kg
STANDARD_DEVIATION 0.9 • n=5 Participants
|
30.0 kg
STANDARD_DEVIATION 10.7 • n=4 Participants
|
29.5 kg
STANDARD_DEVIATION 10.3 • n=21 Participants
|
PRIMARY outcome
Timeframe: This outcome is measured at the time of insertion of the endoscope into the esophagus.Population: Dose of propofol required to prevent movement upon insertion of endoscope
The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0, 0.25, 0.5 and 1 mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on endoscope insertion in children
Outcome measures
| Measure |
Ketamine 0 mg/kg
n=14 Participants
Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
Propofol
|
Ketamine 0.25 mg/kg
n=14 Participants
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 0.5 mg/kg
n=13 Participants
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 1.0 mg/kg
n=14 Participants
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
|---|---|---|---|---|
|
Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus
|
6.1 mg/kg
Interval 4.1 to 8.1
|
4.5 mg/kg
Interval 2.9 to 6.0
|
4.7 mg/kg
Interval 3.1 to 6.2
|
1.1 mg/kg
Interval 0.5 to 1.8
|
SECONDARY outcome
Timeframe: This outcome will be measured after propofol is administered until the end of the procedure.The patient will be observed for apnea after propofol is administered until the endoscopy procedure is complete. Duration of apnea will be recorded.
Outcome measures
| Measure |
Ketamine 0 mg/kg
n=14 Participants
Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
Propofol
|
Ketamine 0.25 mg/kg
n=14 Participants
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 0.5 mg/kg
n=13 Participants
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 1.0 mg/kg
n=14 Participants
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
|---|---|---|---|---|
|
Duration of Apnea After Propofol Administration
|
59 seconds
Standard Deviation 26
|
45 seconds
Standard Deviation 20
|
57 seconds
Standard Deviation 19
|
39 seconds
Standard Deviation 12
|
SECONDARY outcome
Timeframe: From induction of anesthesia until endoscopy procedure is completeAny respiratory adverse event including desaturation \<95 requiring oxygen administration or need for airway management maneuvers (jaw thrust, bag/mask ventilation) to relieve upper airway obstruction
Outcome measures
| Measure |
Ketamine 0 mg/kg
n=14 Participants
Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
Propofol
|
Ketamine 0.25 mg/kg
n=14 Participants
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 0.5 mg/kg
n=13 Participants
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 1.0 mg/kg
n=14 Participants
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
|---|---|---|---|---|
|
Incidence of Adverse Respiratory Events During the Procedure
Desaturation requiring supplemental oxygen
|
11 Participants
|
10 Participants
|
11 Participants
|
9 Participants
|
|
Incidence of Adverse Respiratory Events During the Procedure
Need for airway management
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From the time procedure is complete until discharge from hospital with an average time of 1 hour.Side effects including: hallucinations and/or emergence delirium measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale dizziness nausea and/or vomiting administration of antiemetic pain \> 3/10 at any site (measured using age appropriate scale) time to discharge readiness using established criteria reasons for delayed discharge (if any)
Outcome measures
| Measure |
Ketamine 0 mg/kg
n=14 Participants
Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
Propofol
|
Ketamine 0.25 mg/kg
n=14 Participants
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 0.5 mg/kg
n=13 Participants
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 1.0 mg/kg
n=14 Participants
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
|---|---|---|---|---|
|
Incidence of Side Effects and Complications During the Recovery Period
Hallucinations
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Side Effects and Complications During the Recovery Period
Nausea/vomiting
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Incidence of Side Effects and Complications During the Recovery Period
Dizziness
|
6 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
|
Incidence of Side Effects and Complications During the Recovery Period
Nystagmus/visual disturbance
|
3 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
|
Incidence of Side Effects and Complications During the Recovery Period
Emergence delirium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Ketamine 0 mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Ketamine 0.25 mg/kg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Ketamine 0.5 mg/kg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Ketamine 1.0 mg/kg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine 0 mg/kg
n=14 participants at risk
Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
Propofol
|
Ketamine 0.25 mg/kg
n=14 participants at risk
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 0.5 mg/kg
n=13 participants at risk
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
Ketamine 1.0 mg/kg
n=14 participants at risk
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
Ketamine
Propofol
|
|---|---|---|---|---|
|
Nervous system disorders
Hallucinations
|
0.00%
0/14 • From the time patient enters recovery room to discharge from hospital
|
0.00%
0/14 • From the time patient enters recovery room to discharge from hospital
|
7.7%
1/13 • From the time patient enters recovery room to discharge from hospital
|
0.00%
0/14 • From the time patient enters recovery room to discharge from hospital
|
|
Gastrointestinal disorders
Nausea/vomiting
|
0.00%
0/14 • From the time patient enters recovery room to discharge from hospital
|
0.00%
0/14 • From the time patient enters recovery room to discharge from hospital
|
15.4%
2/13 • From the time patient enters recovery room to discharge from hospital
|
28.6%
4/14 • From the time patient enters recovery room to discharge from hospital
|
|
Nervous system disorders
Dizziness
|
42.9%
6/14 • From the time patient enters recovery room to discharge from hospital
|
50.0%
7/14 • From the time patient enters recovery room to discharge from hospital
|
61.5%
8/13 • From the time patient enters recovery room to discharge from hospital
|
64.3%
9/14 • From the time patient enters recovery room to discharge from hospital
|
|
Nervous system disorders
Nystagmus/visual disturbance
|
21.4%
3/14 • From the time patient enters recovery room to discharge from hospital
|
35.7%
5/14 • From the time patient enters recovery room to discharge from hospital
|
23.1%
3/13 • From the time patient enters recovery room to discharge from hospital
|
64.3%
9/14 • From the time patient enters recovery room to discharge from hospital
|
|
Nervous system disorders
Emergence delirium
|
0.00%
0/14 • From the time patient enters recovery room to discharge from hospital
|
0.00%
0/14 • From the time patient enters recovery room to discharge from hospital
|
0.00%
0/13 • From the time patient enters recovery room to discharge from hospital
|
0.00%
0/14 • From the time patient enters recovery room to discharge from hospital
|
Additional Information
Dr. Jason Hayes
The Hospital for Sick Children, Toronto, Ontario, Canada
Phone: 416-813-7654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place