search
Back to results

Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit (PROPOPAL1)

Primary Purpose

Refractory Pains, End of Life Patients

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
sedation with propofol
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Pains

Eligibility Criteria

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

Inclusion Criteria:

  • patients hospitalized in palliative care unit
  • dying terminally patients
  • pains resisting to fentanyl and MEOPA (Melange equimolaire Oxygène protocyde d'Azote) (EMONO = equimolar mixture of oxygene and nitrous oxide)

Exclusion Criteria:

  • contra-indication to soya
  • contra-indication to egg lecithin
  • Respiratory insufficiency

Sites / Locations

  • Nice University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sedation with propofol

Arm Description

propofol injection: induction with propofol at 20 mg/kg/h. When patient is sleeping, the dosage is deceased to 6 mg/kg/h

Outcomes

Primary Outcome Measures

Feasability of the care without largely pain
The nurse assess if the care could be done without largely pain for the patient. The answer would be "yes" or "not"

Secondary Outcome Measures

asleep delay
time in minutes between injection of propofol and sleep of patient

Full Information

First Posted
March 14, 2014
Last Updated
September 29, 2015
Sponsor
Centre Hospitalier Universitaire de Nice
search

1. Study Identification

Unique Protocol Identification Number
NCT02198404
Brief Title
Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit
Acronym
PROPOPAL1
Official Title
Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation. The investigators believe that Propofol could be used in this instance
Detailed Description
In the palliative care unit, certain patients suffer from pain associated with medical procedures/care which is poorly controlled by antalgics. These situations may necessitate temporary sedation to improve comfort and facilitate treatment. No proven consensus exists, either in the literature or in clinical studies conducted, on the choice of sedative agent however Midazolam is the general recommendation. The investigators believe that Propofol could be used in this instance. The arguments in favour of Propofol include its pharmaco-kinetic characteristics and the fact that it is currently used in other circumstances. Propofol has an action delay which is more rapid that Midazolam therefore its effect is seen 1 minute after a bolus and 5 minutes after for Midazolam. The effect after a short administration lasts only a few minutes however the effect of Midazolam is more prolonged (sometimes several hours). As with Midazolam, a titrated use in weaker doses, should allow sufficient sedation, in the context which interests us, without marked secondary effects. It is not unreasonable to think that the short action duration of Propofol could minimise respiratory risks in the hours after the treatment compared to Midazolam. With Propofol, the patient wakes as soon as the painful medical procedure has finished, with Midazolam sedation may be prolonged to several hours leading to a risk respiratory depression or secretion retention. For these reasons; the investigators would like to verify that the use of Propofol is feasible in the context of refractory pain associated with medical procedures (dressing changes, movement during personal care tasks e.g. washing) in the palliative care unit. This is a preliminary study prior to completion of a more extensive multi-centre research project on the role Propofol could play in this situation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Pains, End of Life Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sedation with propofol
Arm Type
Experimental
Arm Description
propofol injection: induction with propofol at 20 mg/kg/h. When patient is sleeping, the dosage is deceased to 6 mg/kg/h
Intervention Type
Drug
Intervention Name(s)
sedation with propofol
Intervention Description
induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h
Primary Outcome Measure Information:
Title
Feasability of the care without largely pain
Description
The nurse assess if the care could be done without largely pain for the patient. The answer would be "yes" or "not"
Time Frame
at inclusion (day=0), after the care
Secondary Outcome Measure Information:
Title
asleep delay
Description
time in minutes between injection of propofol and sleep of patient
Time Frame
at the inclusion (day=0), delay between sleep-inducing medicine injection and asleep

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients hospitalized in palliative care unit dying terminally patients pains resisting to fentanyl and MEOPA (Melange equimolaire Oxygène protocyde d'Azote) (EMONO = equimolar mixture of oxygene and nitrous oxide) Exclusion Criteria: contra-indication to soya contra-indication to egg lecithin Respiratory insufficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CIAIS JEAN-FRANCOIS, PhD
Email
ciais.jf@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CIAIS Jean-François, PhD
Organizational Affiliation
Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEAN-FRANCOIS CIAIS, PhD
First Name & Middle Initial & Last Name & Degree
FLORA TREMELLAT, PhD
First Name & Middle Initial & Last Name & Degree
MAUD CASTELLI PRIETO, PhD

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of Sedation With Propofol in Refractory Pains Due to Care in Palliative Care Unit

We'll reach out to this number within 24 hrs