Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171910
• Other study ID #: Doxa1
• 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

• Hypoxia
• Sedation

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