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The purpose of this study is to examine the dose-response relationship of ketamine in combination with propofol.
Direct visualization of the esophagus, stomach and small intestine is performed using a scope that is inserted while the patient is under under deep sedation or general anesthesia. The most common method of providing general anesthesia for upper endoscopy is intravenous administration of medications such as propofol, often in combination with other medications such as fentanyl, midazolam, remifentanil or ketamine. One study found that the combination of propofol and ketamine provides better conditions (less patient movement, more stable heart and breathing) but more side effects afterwards compared to propofol and fentanyl.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine 0 mg/kg | Experimental | 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. |
|
| Ketamine 0.25 mg/kg | Experimental | 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 0.5 mg/kg | Experimental | 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 1.0 mg/kg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug |
| ||
| Propofol |
| Measure | Description | Time Frame |
|---|---|---|
| Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus | 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 | This outcome is measured at the time of insertion of the endoscope into the esophagus. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Apnea After Propofol Administration | The patient will be observed for apnea after propofol is administered until the endoscopy procedure is complete. Duration of apnea will be recorded. | This outcome will be measured after propofol is administered until the end of the procedure. |
| Incidence of Adverse Respiratory Events During the Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Hayes | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30032885 | Derived | Hayes J, Matava C, Pehora C, El-Beheiry H, Jarvis S, Finkelstein Y. Determination of the median effective dose of propofol in combination with different doses of ketamine during gastro-duodenoscopy in children: a randomised controlled trial. Br J Anaesth. 2018 Aug;121(2):453-461. doi: 10.1016/j.bja.2018.03.037. Epub 2018 Jun 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ketamine 0.25 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus | 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 | Dose of propofol required to prevent movement upon insertion of endoscope | Posted | Mean | 95% Confidence Interval | mg/kg | This outcome is measured at the time of insertion of the endoscope into the esophagus. |
|
From the time patient enters recovery room to discharge from hospital
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hallucinations | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Hayes | The Hospital for Sick Children, Toronto, Ontario, Canada | 416-813-7654 | 208963 | jason.hayes@sickkids.ca |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
Any 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 |
| From induction of anesthesia until endoscopy procedure is complete |
| Incidence of Side Effects and Complications During the Recovery Period | 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) | From the time procedure is complete until discharge from hospital with an average time of 1 hour. |
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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 |
| 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 |
| OG002 | 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 |
| OG003 | 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 |
|
|
| Secondary | Duration of Apnea After Propofol Administration | The patient will be observed for apnea after propofol is administered until the endoscopy procedure is complete. Duration of apnea will be recorded. | Posted | Mean | Standard Deviation | seconds | This outcome will be measured after propofol is administered until the end of the procedure. |
|
|
|
| Secondary | Incidence of Adverse Respiratory Events During the Procedure | Any 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 | Posted | Count of Participants | Participants | From induction of anesthesia until endoscopy procedure is complete |
|
|
|
| Secondary | Incidence of Side Effects and Complications During the Recovery Period | 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) | Posted | Count of Participants | Participants | From the time procedure is complete until discharge from hospital with an average time of 1 hour. |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 7 |
| 14 |
| EG001 | 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 | 0 | 14 | 0 | 14 | 8 | 14 |
| EG002 | 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 | 0 | 13 | 0 | 13 | 10 | 13 |
| EG003 | 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 | 0 | 14 | 0 | 14 | 11 | 14 |
| Nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Nystagmus/visual disturbance | Nervous system disorders | Systematic Assessment |
|
| Emergence delirium | Nervous system disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| Need for airway management |
|
| Nausea/vomiting |
|
| Dizziness |
|
| Nystagmus/visual disturbance |
|
| Emergence delirium |
|