Ketamine and Propofol for Upper Endoscopy

The Hospital for Sick Children

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Ketamine; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02295553

1000036780

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 4 patient groups

Ketamine 0 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Ketamine 0.25 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Drug: Ketamine

Ketamine 0.5 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Drug: Ketamine

Ketamine 1.0 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Drug: Ketamine