Ketamine and Propofol for Upper Endoscopy

The Hospital for Sick Children56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anesthesia

Interventions

KetamineDRUG

PropofolDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 13 Years

Medical Language ↔ Plain English

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

Locations (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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