SedationPhase 4NCT02171910
Doxapram as an Additive to Propofol Sedation in Sedation for ERCP
A Phase 4 study testing Doxapram in people with Sedation and Hypoxia, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Doxapram
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2016to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- < 75 year of age
- Having ERCP
- Agrees to take part in the study
Who cannot join
- >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 locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital
Helsinki, Uusimaa, 00029 HUS
About this study
Official title: Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography
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.
Read more
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.
- Being tested
- Doxapram, Placebo
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde, Sedation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxapramDrug
Also called Dopram, Stimulex, Respiram
PlaceboDrug
An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Doxapram |
| Placebo | Placebo comparator | Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial oxygenation
Hypoxemia, oxygen saturation by pulse oximetry (SpO2 <90%), considered as a significant change
Measured: 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 (3)
change in systolic arterial pressure
A drop of systolic arterial pressure to <90 mmHg is considered significant
Measured: 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)
Measured: 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)
Measured: values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jarno Jokelainen, MD, Helsinki University Central Hospital
- Investigators
- Jarno Jokelainen, M.D., Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171910
- Sponsor's protocol ID
- Doxa1
- Status last verified
- Dec 2016
- First submitted
- 15 Jun 2014
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31993819
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT02171910
- Acronym / sponsor ID
- Doxa1
- Keywords
- Cholangiopancreatography, Endoscopic Retrograde, Sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxapram | Active comparator | Drug: DoxapramPropofol 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 | Drug: PlaceboPropofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- < 75 year of age
- Having ERCP
- Agrees to take part in the study
Key exclusion criteria (7 listed)
- >75 years of age
- allergy to propofol or doxapram
- epilepsy
- Chronic Obstructive Pulmonary disease (COPD)
- Coronary artery disease (symptomatic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxapramAlso: Dopram, Stimulex, Respiram | Drug | Doxapram |
| PlaceboAn injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram | Drug | Placebo |
Primary outcome
Change in arterial oxygenation
Time frame: 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
3 secondary outcomes
change in systolic arterial pressure
Time frame: 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)
Time frame: 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)
Time frame: values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Derived from this study: PubMed 31993819Jokelainen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarno Jokelainen, M.D. principal investigator
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxapram in people with Sedation and Hypoxia, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arterial oxygenation (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.