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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02171910
Other study ID # Doxa1
Secondary ID
Status Completed
Phase Phase 4
First received June 15, 2014
Last updated December 2, 2016
Start date October 2016
Est. completion date December 2016

Study information

Verified date December 2016
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics CommitteeFinland: Finnish Medicines Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Doxapram

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

Locations

Country Name City State
Finland Helsinki University Central Hospital Helsinki Uusimaa

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Sedation scales 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 No
Other End-tidal carbon dioxide (CO2) 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 No
Other Patient satisfaction 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 No
Other operating physician satisfaction 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 No
Primary Change in arterial oxygenation 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 Yes
Secondary change in systolic arterial pressure 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 Yes
Secondary Pulse (heartbeats/minute) 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 Yes
Secondary breathing rate (breaths/minute) values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure Yes
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