Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2016
• Main ID: NCT02171910
• Date of registration: 15/06/2014
• Prospective Registration: Yes
• Primary sponsor: Helsinki University Central Hospital
• Public title: Doxapram as an Additive to Propofol Sedation in Sedation for ERCP
• Scientific title: Doxapram as an Additive to Propofol Sedation in Sedation for Endoscopic Retrograde Cholangiopancreatography
• Date of first enrolment: October 2016
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02171910
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
• Phase: Phase 4

Countries of recruitment

Finland

Contacts

• Name: Jarno Jokelainen, M.D.
• Affiliation: Helsinki University Central Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypoxia

Sedation

Intervention(s)

Drug: Placebo

Drug: Doxapram

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

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]

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]

Secondary ID(s)

Doxa1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors