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Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

NCT ID: NCT02171910

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Sedation Hypoxia

Keywords

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Cholangiopancreatography, Endoscopic Retrograde Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Doxapram

Propofol sedation with a doxapram 1mg/kg i.v. bolus at induction and an i.v. infusion 1mg/kg/h) during the procedure

Group Type ACTIVE_COMPARATOR

Doxapram

Intervention Type DRUG

Placebo

Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram

Interventions

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Doxapram

Intervention Type DRUG

Placebo

An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram

Intervention Type DRUG

Other Intervention Names

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Dopram Stimulex Respiram

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jarno Jokelainen, MD

Senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jarno Jokelainen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 31993819 (View on PubMed)

Other Identifiers

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Doxa1

Identifier Type: -

Identifier Source: org_study_id