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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxapram | Active Comparator | Propofol sedation with a doxapram 1mg/kg i.v. bolus at induction and an i.v. infusion 1mg/kg/h) during the procedure |
|
| Placebo | Placebo Comparator | Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxapram | Drug |
|
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation scales | Modified observer's assessment of Alertness/sedation (MOAA(S) and Bispectral Index (BiS) | values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure |
| End-tidal carbon dioxide (CO2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jarno Jokelainen, M.D. | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | Uusimaa | 00029 HUS | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31993819 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 6, 2021 | |
| Reset | Apr 30, 2021 | |
| Release | Feb 28, 2023 | |
| Reset | Dec 11, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 6, 2021 | Apr 30, 2021 | |||
| Feb 28, 2023 |
| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004315 | Doxapram |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram |
|
| 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 |
A sampling catheter is placed in the nostril
| values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure |
| Patient satisfaction | The patient is asked to rate satisfaction to the given sedation on a seven step scale ranging from extremely dissatisfied to extremely satisfied | in the recovery room before discharge to ward |
| operating physician satisfaction | The operating physician is given a questionnaire and rates the following on a 4 step scale each: ease of applying the endoscope, patient co-operation, gagging/vomiting, coughing, belching, distracting movement of the patient. Also difficulty of the procedure is rated on a three step scale | at the end of the procedure |
| Dec 11, 2023 |