Ketamine and Propofol for Upper Endoscopy

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295553
• Other study ID #: 1000036780
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Ketamine

• Propofol

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	This outcome is measured at the time of insertion of the endoscope into the esophagus.
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.	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	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)	From the time procedure is complete until discharge from hospital with an average time of 1 hour.