Doxapram as an Additive to Propofol Sedation in Sedation for ERCP

NCT02171910 | Completed Phase 4

• 1 other identifier: Doxa1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Hypoxia

Keywords

Cholangiopancreatography, Endoscopic Retrograde; Sedation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• change in systolic arterial pressure

  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

• 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

• breathing rate (breaths/minute)

  values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure

Other Outcomes (4)

• Sedation scales

  values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure

• End-tidal carbon dioxide (CO2)

  values recorded before the procedure, during the procedure at 5 min intervals and at the end of the procedure

• Patient satisfaction

  in the recovery room before discharge to ward

Study Arms (2)

Doxapram

ACTIVE COMPARATOR

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

Drug: Doxapram

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Doxapram DRUG

Also known as: Dopram, Stimulex, Respiram

Doxapram

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 75 year of age
• Having ERCP
• Agrees to take part in the study

You may not qualify if:

• \>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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00029 HUS, Finland

Location

Related Publications (1)

• 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.

  PMID: 31993819 DERIVED

MeSH Terms

Conditions

Hypoxia

Interventions

Doxapram

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jarno Jokelainen, M.D.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physician

Study Record Dates

• First Submitted: June 15, 2014
• First Posted: June 24, 2014
• Study Start: October 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

FI (1)