Remifentanil is a usefull medication for procedural sedation and analgesia (PSA) in the emergency department and the recovery time is shorter compared to the frequently used combination propofol / fentanyl?
ID
Bron
Aandoening
remifentanil, target controlled infusion, procedural sedation, analgesia, recovery time, emergency department, propofol, fentanyl.
procedurele sedatie, pijnstilling, hersteltijd, spoedeisende hulp.
Ondersteuning
M.A.A. van Hooft
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The recovery time ( time between last dose PSA medication and full recovery of the patient).
Achtergrond van het onderzoek
We would like to know if remifentanil is a useful medication for PSA in the often busy emergency department (ED) and if the recovery time and time till discharge from the ED is shorter compared with the often used combination of fentanyl and propofol.
Prospective randomized not blinded clinical study design. The patient is assigned to one of the three groups:
1 Fentanyl / propofol group
2 Remifentanil-TCI * / propofol group
3 Remifentanil-TCI group *
* Target Controlled Infusion
Outcomes
Primary outcome: recovery time
Secondary outcome: adverse effects/ complications, successful intervention, satisfaction of the specialist about
performing the intervention, adequate analgesia during procedure, satisfaction patient.
Hypothesis:
We expect that remifentanil will be useful medication for PSA at the ED with a shorter recovery time and faster discharge of the patient from the ED compared with the frequently used combination propofol / fentanyl.
Doel van het onderzoek
Remifentanil is a usefull medication for procedural sedation and analgesia (PSA) in the emergency department and the recovery time is shorter compared to the frequently used combination propofol / fentanyl?
Onderzoeksopzet
From 5 minutes before the procedure, the vital signs are checked every 5 minutes. Immediately after the procedure, the intervention is evaluated with the doctors involved and the patient. Also, the following
information is listed on the registration form:The medication and total dosage of analgesic, sedative, concomitant medications, antidote, other
medications administered , additional O2 need, deepest Ramsay sedation score, occurrence of incidents / complication and various times (time start PSA, time start surgery, surgery end time, date last gift PSA medication, time patient fully recovers from PSA, patient discharge
time).
Onderzoeksproduct en/of interventie
There are three groups in which different PSA medication is administered.
One group gets fentanyl and propofol which is a often used combination of medication for PSA (this is the active control).First dose fentanyl is 1ug/kg iv. First dose propofol is 0,25 mg/kg iv. The dose is titrated to effect.
One group gets remifentanil with a TCI pump (Target Controlled Infusion (TCI) with an approved infusion pump, which is equipped with the Minto pharmacokinetic model with covariates for age and lean body mass) and propofol. The target plasma concentration remifentanil starts with 1 ng/ml and can be titrated to effect till a maximum target plasma concentration of 5 ng/ml. First dose propofol is 0,25 mg/kg iv. The dose is titrated to effect.
One group will get only remifentanil, with a TCI pump (Target Controlled Infusion (TCI) with an approved infusion pump, which is equipped with the Minto pharmacokinetic model with covariates for age and lean body mass).The target plasma concentration remifentanil starts with 1 ng/ml and can be titrated to effect till a maximum target plasma concentration of 5 ng/ml.
Publiek
M.A.A.
van Hooft
Albert Schweitzerplaats 25 - Postbus 444
3300 AK
Tel: 078-654 11 11
Wetenschappelijk
M.A.A.
van Hooft
Albert Schweitzerplaats 25 - Postbus 444
3300 AK
Tel: 078-654 11 11
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All the patients who need procedural sedation and analgesia at the emergency department or the observatorium of the Albert Schweitzer hospital location Dordwijk in Dordrecht, age 18 years and older, classified as ASA I en II.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Age under 18 years, hemodynamic and/or respiratory instable, classified as ASA III, IV and V, suspicion of elevated intra-cranial pressure, pregnancy, use of opiates at home, opiates administered before PSA procedure started (in the ambulance, on arrival at the emergency department), intoxication, known allergy for fentanyl propofol remifentanil soy or chicken proteins.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5100 |
NTR-old | NTR5232 |
Ander register | EudraCT number: 2013-003220-36, METC file number: NL45112.101.14 : ABR Number 45112 |