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Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

Primary Purpose

Sedation, Hypoxia

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Doxapram
Placebo
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sedation focused on measuring Cholangiopancreatography, Endoscopic Retrograde, Sedation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Doxapram

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in arterial oxygenation
Hypoxemia, oxygen saturation by pulse oximetry (SpO2 <90%), considered as a significant change

Secondary Outcome Measures

change in systolic arterial pressure
A drop of systolic arterial pressure to <90 mmHg is considered significant
Pulse (heartbeats/minute)
breathing rate (breaths/minute)

Full Information

First Posted
June 15, 2014
Last Updated
December 2, 2016
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02171910
Brief Title
Doxapram as an Additive to Propofol Sedation in Sedation for ERCP
Official Title
Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation, Hypoxia
Keywords
Cholangiopancreatography, Endoscopic Retrograde, Sedation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxapram
Arm Type
Active Comparator
Arm Description
Propofol sedation with a doxapram 1mg/kg i.v. bolus at induction and an i.v. infusion 1mg/kg/h) during the procedure
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Propofol sedation with a placebo i.v. bolus at induction and a placebo i.v. infusion during the procedure
Intervention Type
Drug
Intervention Name(s)
Doxapram
Other Intervention Name(s)
Dopram, Stimulex, Respiram
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram
Primary Outcome Measure Information:
Title
Change in arterial oxygenation
Description
Hypoxemia, oxygen saturation by pulse oximetry (SpO2 <90%), considered as a significant change
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
Secondary Outcome Measure Information:
Title
change in systolic arterial pressure
Description
A drop of systolic arterial pressure to <90 mmHg is considered significant
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
Title
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
Title
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 Pre-specified Outcome Measures:
Title
Sedation scales
Description
Modified observer's assessment of Alertness/sedation (MOAA(S) and Bispectral Index (BiS)
Time Frame
values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure
Title
End-tidal carbon dioxide (CO2)
Description
A sampling catheter is placed in the nostril
Time Frame
values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure
Title
Patient satisfaction
Description
The patient is asked to rate satisfaction to the given sedation on a seven step scale ranging from extremely dissatisfied to extremely satisfied
Time Frame
in the recovery room before discharge to ward
Title
operating physician satisfaction
Description
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
Time Frame
at the end of the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarno Jokelainen, M.D.
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029 HUS
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31993819
Citation
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.
Results Reference
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Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

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