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Completed

NCT Number: NCT02171910

Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

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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Key information

Conditions

Sedation Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital

Helsinki, Uusimaa, 00029 HUS, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxapram

Drug

Other names: Dopram, Stimulex, Respiram

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2014
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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