Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

Phase 4

Completed

• Conditions: Sedation; Hypoxia
• Interventions: Drug: Placebo; Drug: Doxapram

• Registration Number: NCT02171910
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-15
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Study Start: 2016-10
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure
Doxapram	Doxapram	Propofol sedation with a doxapram 1mg/kg i.v. bolus at induction and an i.v. infusion 1mg/kg/h) during the procedure

Primary Outcome Measures

Name	Time	Method
Change in arterial oxygenation	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	Hypoxemia, oxygen saturation by pulse oximetry (SpO2 \<90%), considered as a significant change

Secondary Outcome Measures

Name	Time	Method
change in systolic arterial pressure	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	A drop of systolic arterial pressure to \<90 mmHg is considered significant
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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Uusimaa, Finland