A Phase 4 interventional study of Ketamine and Propofol in Anesthesia, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 3 Years to 13 Years. Per ClinicalTrials.gov, last updated 2019-06-10.
Sponsored by The Hospital for Sick Children · Phase 4, Interventional, and Treatment
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.
The Hospital for Sick Children is the lead sponsor of 577 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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 · Drug: 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.
Drug: Ketamine · Drug: 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.
Drug: Ketamine · Drug: Propofol
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
Time frame: This outcome is measured at the time of insertion of the endoscope into the esophagus.
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.
Time frame: 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
Time frame: 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)
Time frame: From the time procedure is complete until discharge from hospital with an average time of 1 hour.
| Milestone | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg |
|---|---|---|---|---|
| Started | 14 | 14 | 14 | 14 |
| Completed | 14 | 14 | 13 | 13 |
| Not completed | 0 | 0 | 1 | 1 |
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
| mg/kg | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg |
|---|---|---|---|---|
| Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus | 6.1 (4.1 to 8.1) | 4.5 (2.9 to 6) | 4.7 (3.1 to 6.2) | 1.1 (0.5 to 1.8) |
The patient will be observed for apnea after propofol is administered until the endoscopy procedure is complete. Duration of apnea will be recorded.
| seconds | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg |
|---|---|---|---|---|
| Duration of Apnea After Propofol Administration | 59 ± 26 | 45 ± 20 | 57 ± 19 | 39 ± 12 |
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
| Participants | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg |
|---|---|---|---|---|
| Desaturation requiring supplemental oxygen | 11 | 10 | 11 | 9 |
| Need for airway management | 1 | 1 | 2 | 1 |
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)
| Participants | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg |
|---|---|---|---|---|
| Hallucinations | 0 | 0 | 1 | 0 |
| Nausea/vomiting | 0 | 0 | 2 | 4 |
| Dizziness | 6 | 7 | 8 | 9 |
| Nystagmus/visual disturbance | 3 | 5 | 3 | 9 |
| Emergence delirium | 0 | 0 | 0 | 0 |
Collected over From the time patient enters recovery room to discharge from hospital. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine 0 mg/kg | 0/14 (0%) | 0/14 (0%) | 7/14 (50%) |
| Ketamine 0.25 mg/kg | 0/14 (0%) | 0/14 (0%) | 8/14 (57.1%) |
| Ketamine 0.5 mg/kg | 0/13 (0%) | 0/13 (0%) | 10/13 (76.9%) |
| Ketamine 1.0 mg/kg | 0/14 (0%) | 0/14 (0%) | 11/14 (78.6%) |
| Event | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg |
|---|---|---|---|---|
| DizzinessNervous system disorders | 6/14 | 7/14 | 8/13 | 9/14 |
| Nystagmus/visual disturbanceNervous system disorders | 3/14 | 5/14 | 3/13 | 9/14 |
| Nausea/vomitingGastrointestinal disorders | 0/14 | 0/14 | 2/13 | 4/14 |
| HallucinationsNervous system disorders | 0/14 | 0/14 | 1/13 | 0/14 |
| Emergence deliriumNervous system disorders | 0/14 | 0/14 | 0/13 | 0/14 |
| Age, Continuous(years) | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Total |
|---|---|---|---|---|---|
| Mean | 8.4 ± 2.8 | 8.9 ± 2.7 | 8.9 ± 2.1 | 8.9 ± 2.5 | 8.8 ± 2.5 |
| Sex/Gender, Customized(Participants) | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Total |
|---|---|---|---|---|---|
| Count of participants | NA | NA | NA | NA | NA |
| Weight(kg) | Ketamine 0 mg/kg | Ketamine 0.25 mg/kg | Ketamine 0.5 mg/kg | Ketamine 1.0 mg/kg | Total |
|---|---|---|---|---|---|
| Mean | 30.1 ± 12.4 | 28.5 ± 8.9 | 29.5 ± 0.9 | 30.0 ± 10.7 | 29.5 ± 10.3 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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