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Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02171910
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Jarno Jokelainen, MD, Helsinki University Central Hospital

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.


Condition or disease Intervention/treatment Phase
Sedation Hypoxia Drug: Doxapram Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography
Study Start Date : October 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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 ]

Other Outcome Measures:
  1. 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)

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171910


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland, 00029 HUS
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Principal Investigator: Jarno Jokelainen, M.D. Helsinki University Central Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jarno Jokelainen, MD, Senior physician, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02171910    
Other Study ID Numbers: Doxa1
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Keywords provided by Jarno Jokelainen, MD, Helsinki University Central Hospital:
Cholangiopancreatography, Endoscopic Retrograde
Sedation
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Doxapram
Central Nervous System Stimulants
Physiological Effects of Drugs
Respiratory System Agents