Ketamine and Propofol for Upper Endoscopy

Study Overview
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Brief Summary
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The purpose of this study is to examine the dose-response relationship of ketamine in combination with propofol.

Detailed Description
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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.

Official Title
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Co-administration of Ketamine and Propofol for Upper Endoscopy in Children: a Dose-finding Study

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Ketamine
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3-13 years Receiving general anesthesia for upper endoscopy Exclusion Criteria: Known or possible difficult airway BMI > 35 Weight < 10 kg Sedative premedication required Known contraindication to ketamine or propofol

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine 0 mg/kg<br>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. | Drug: Propofol<br> <br> |
| Experimental: Ketamine 0.25 mg/kg<br>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. | Drug: Ketamine<br> <br> Drug: Propofol<br> <br> |
| Experimental: Ketamine 0.5 mg/kg<br>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. | Drug: Ketamine<br> <br> Drug: Propofol<br> <br> |
| Experimental: Ketamine 1.0 mg/kg<br>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. | Drug: Ketamine<br> <br> Drug: Propofol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Propofol, Children, Pediatrics, Upper endoscopy