NCT02198404

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2015

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

March 14, 2014

Last Update Submit

November 15, 2023

Conditions

Refractory PainsEnd of Life Patients

Outcome Measures

Primary Outcomes (1)

  • 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"

    at inclusion (day=0), after the care

Secondary Outcomes (1)

  • asleep delay

    at the inclusion (day=0), delay between sleep-inducing medicine injection and asleep

Study Arms (1)

sedation with propofol

EXPERIMENTAL

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

Drug: sedation with propofol

Interventions

sedation with propofolDRUG

induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h

sedation with propofol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Pain, Intractable

Interventions

Propofol

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • CIAIS Jean-François, PhD

    Nice University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

July 23, 2014

Study Start

June 20, 2014

Primary Completion

September 29, 2015

Study Completion

September 29, 2015

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

FR(1)