Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

Study Overview
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Brief Summary
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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.

Official Title
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Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography

Conditions
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Sedation, Hypoxia

Intervention / Treatment
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* Drug: Doxapram
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Doxapram<br>Propofol sedation with a doxapram 1mg/kg i.v. bolus at induction and an i.v. infusion 1mg/kg/h) during the procedure | Drug: Doxapram<br> <br> * Other names: Respiram;|
| Placebo Comparator: Placebo<br>Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure | Drug: Placebo<br>* An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in arterial oxygenation | Hypoxemia, oxygen saturation by pulse oximetry (SpO2 <90%), considered as a significant change | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in systolic arterial pressure | A drop of systolic arterial pressure to <90 mmHg is considered significant | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward | 
| Pulse (heartbeats/minute) |  | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure, on arrival at the recovery room and at 5 min, 10 min, and after that at 10 min intervals until discharge to ward | 
| breathing rate (breaths/minute) |  | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Cholangiopancreatography, Endoscopic Retrograde