Clinical trial NCT02171910: Doxapram as an Additive to Propofol Sedation in Sedation for ERCP
Official title: Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Hypoxia
Keywords: Cholangiopancreatography, Endoscopic Retrograde
Sedation
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in arterial oxygenation
timeFrame: 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 outcomes:
measure: change in systolic arterial pressure
timeFrame: 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
measure: Pulse (heartbeats/minute)
timeFrame: 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
measure: breathing rate (breaths/minute)
timeFrame: values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure
Other outcomes:
measure: Sedation scales
timeFrame: values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure
measure: End-tidal carbon dioxide (CO2)
timeFrame: values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure
measure: Patient satisfaction
timeFrame: in the recovery room before discharge to ward
measure: operating physician satisfaction
timeFrame: at the end of the procedure
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Central Hospital
name: Jarno Jokelainen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jokelainen J, Belozerskikh A, Mustonen H, Udd M, Kylanpaa L, Lindstrom O, Mazanikov M, Poyhia R. Doxapram as an additive to propofol sedation for endoscopic retrograde cholangiopancreatography: a placebo-controlled, randomized, double-blinded study. Surg Endosc. 2020 Dec;34(12):5477-5483. doi: 10.1007/s00464-019-07344-2. Epub 2020 Jan 28.