Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Hypoxia; Sedation

Treatments: Drug: Doxapram; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02171910

Doxa1

Details and patient eligibility

About

Sedation is needed in order to complete endoscopic retrograde cholangiopancreatography (ERCP) to alleviate discomfort and pain during the procedure. This is usually achieved with use of opioids and/or sedative agents such as benzodiazepines or propofol. Traditionally benzodiazepines have been used but nowadays propofol is becoming the drug of choice for sedation during ERCP.

The problem with propofol sedation is the fact that it may case cardiorespiratory depression and there is no antidote for this like there is for benzodiazepines. Cardiovascular depression can usually be easily counteracted with drugs that are used to raise blood pressure or heart rate during general anesthesia but respiratory depression remains a problem.

The aim of this study is to try to counteract the respiratory depression caused by propofol sedation using an old respiratory stimulant doxapram as opposed to placebo using a double blind randomized protocol.

The investigators hypothesis is that boluses and an infusion of doxapram will alleviate the respiratory depression caused by propofol sedation.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• < 75 year of age
• Having ERCP
• Agrees to take part in the study

Exclusion criteria

• >75 years of age
• allergy to propofol or doxapram
• epilepsy
• Chronic Obstructive Pulmonary disease (COPD)
• Coronary artery disease (symptomatic)
• alcoholism
• declines to take part in the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Doxapram

Active Comparator group

Description:

Propofol sedation with a doxapram 1mg/kg i.v. bolus at induction and an i.v. infusion 1mg/kg/h) during the procedure

Treatment:

Drug: Doxapram

Placebo

Placebo Comparator group

Description:

Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure

Treatment:

Drug: Placebo