Ketamine and Propofol for Upper Endoscopy
- Registration Number
- NCT02295553
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
The purpose of this study is to examine the dose-response relationship of ketamine in combination with propofol.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Age 3-13 years
- Receiving general anesthesia for upper endoscopy
- Known or possible difficult airway
- BMI > 35
- Weight < 10 kg
- Sedative premedication required
- Known contraindication to ketamine or propofol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine 0 mg/kg Propofol 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 Ketamine 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 0.25 mg/kg Propofol 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 Propofol 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 0.5 mg/kg Ketamine 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 Propofol 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 1.0 mg/kg Ketamine 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.
- Primary Outcome Measures
Name Time Method Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus This outcome is measured at the time of insertion of the endoscope into the 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
- Secondary Outcome Measures
Name Time Method Duration of Apnea After Propofol Administration 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.
Incidence of Adverse Respiratory Events During the Procedure From induction of anesthesia until endoscopy procedure is complete 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
Incidence of Side Effects and Complications During the Recovery Period 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)
Trial Locations
- Locations (1)
The Hospital for Sick Children
đŸ‡¨đŸ‡¦Toronto, Ontario, Canada