Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03783494 |
| Other study ID # |
18-PP-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
May 9, 2019 |
| Est. completion date |
October 25, 2020 |
Study information
| Verified date |
November 2023 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation
in order to perform very painful emergency emergent procedures such as displaced fracture or
dislocated joints reduction. Propofol is recommended for this purpose, injected administered
in slow IV bolus injections according to the technique known as manual titration. But despite
this precaution, temporarily excessive sedation can happen, and a side effect can appear
(arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an
anesthesia technique that permits to obtain a precise constant and stable concentration of
medication, boluses volumes of injection being calculated and delivered automatically by an
electric syringe equipped with a software obedient to existing pharmacokinetic models. In the
operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the
operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2
to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in
emergency departments (ED), the brain propofol concentrations which are necessary for
sedation and awakening of the patient are not known and must be determined experimentally.
In this single-center, prospective, interventional study, safety and feasibility of TCI will
be studied in one ED with the primary objective of determining the brain propofol
concentrations necessary to reach the an optimal sedation in for patients with indications of
sustaining very painful orthopedic emergency emergent procedures
Description:
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation
in order to perform very painful emergency emergent procedures such as displaced fracture or
dislocated joints reduction. For this purpose, propofol is a remarkable sedative agent for
its very short elimination half-life, antiemetic property and myorelaxant effects. It is
recommended to inject administer it in slow IV boluses injections according to the technique
known as manual titration, but despite this precaution, temporarily excessive sedation can
happen, and a side effect appear (arterial hypotension or respiratory depression).
Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise
constant and stable concentration of medication, boluses volumes of injection being
calculated and delivered automatically by an electric syringe equipped with a software
obedient to existing pharmacokinetic models.
The age, size and weight of the patient are filledentered, then the syringe delivers the
volume which is necessary and sufficient to reach and maintain the target concentration
chosen by the practitioner. For anesthetic induction in the operating room, the brain
concentrations of propofol used range from 2 to 6 μg/mL, then the general anesthesia
maintenance is obtained with 2 to 4 μg/mL, and the patient awakening usually happens between
0.8 and 1.2 μg/mL. Since TCI has never been used in emergency departments (ED), the brain
propofol concentrations which are necessary for sedation and awakening of the patient are not
known and must be determined experimentally.
In this single-center, prospective, interventional study, safety and feasibility of TCI will
be studied in an ED with the primary objective of determining the brain propofol
concentrations necessary to reach the an optimal sedation in for patients with indications
ofsustaining very painful orthopedic emergency emergent procedures. As secondary objectives,
we will study the characteristics of sedations obtained (level, delays, lengths); the Delays,
lengths and levels of sedation obtained, overall delivered doses of propofol administered;
the , nature, appearance delays and lengths of potential adverse events (AE) related to
procedural sedation, particularly complications related to procedural sedation, and necessary
interventions necessary to handle these AE., will be studied as secondary objectives
