Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

December 2, 2016 updated by: Jarno Jokelainen, MD, Helsinki University Central Hospital

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029 HUS
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Doxapram
Propofol sedation with a doxapram 1mg/kg i.v. bolus at induction and an i.v. infusion 1mg/kg/h) during the procedure
Drug: Doxapram
Other Names:
  • Dopram
  • Stimulex
  • Respiram
Placebo Comparator: Placebo
Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure
Drug: Placebo
An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation scales
Time Frame: values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure
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)
Time Frame: 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
Time Frame: in the recovery room before discharge to ward
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
Time Frame: at the end of the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Jarno Jokelainen, M.D., Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 15, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doxa1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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