Medical and post surgical ICU patient requiring analgesia and sedation. MedDRA version: 6.1 Level: PT Classification code 10039897
Conditions
Interventions
Trade Name: ULTIVA*IV 5FL 5MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Remifentanil
CAS Number: 132539-07-2
Concentration unit: µg microgram(s)
Concentration type: equal
Concentr
Sponsors
GLAXO SMITHKLINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 18 years or more 2.Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation. 3.Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug. 4.Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid. 5.Women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control that must be recorded on the source documentation at each visit; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows a.Non-childbearing potential i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses b.Child-bearing potential, has a negative serum pregnancy test result at the Screening Visit and negative urine dipstick pregnancy tests before starting study medication and on the other occasions, and agrees to one of the following -Male partner who is sterile prior to the female subject s entry into the study and is the sole sexual partner for that female subject -Oral contraceptives either combined or progestogen only with barrier method of contraception consisting of condom or diaphragm before and throughout the clinical trial, and for one month following the last dose of study medication. Women of child-bearing potential using an oral contraceptive in combination with a barrier method of contraception are required to continue to use this form of contraception for one month following discontinuation of study medication. -Barrier method of contraception consisting of condom or diaphragm -IUD with a documented failure rate of less than 1 per year -Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug minimum for one month, equivalent to five half lives . -the subjects will remain abstinent during the period described above, but they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active. 6.Subjects provided written informed consent for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Diagnosis resuscitation in the previous 24 hours, all traumatisms or expecting to require major surgery within the next three days 2.Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided 3.Concurrent medications -Requires or is likely to require neuromuscular blocking agents to facilitate mechanical ventilation -Has or is likely to receive an epidural block during the treatment period 4.The use of remifentanil or propofol is contraindicated 5.Drug allergy history of allergic hypersensitivity to fentanyl analogues, morphine, benzodiazepines or propofol 6.History of alcohol abuse 7.History of drug abuse, defined as -Patterns of substance intake consistent with disruption of normal function in society -Past or current impairment of organ function reasonably related to substance intake 8.Previous entry into this study or participation in any other investigational drug study within 30 days of study entry 9.Currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device 10.Protocol specified treatment regimens would be inappropriate for the management of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantify the difference in time on the mechanical ventilator when using an analgesia based regimen with remifentanil, as compared with a conventional sedation regimen with propofol.;Primary end point(s): Duration of time on mechanical ventilation reducing the duration of mechanical ventilation may reduce the length of stay and therefore reduce the costs per patient. Due to its unique profile, remifentanil may help to reduce the duration of mechanical ventilation .;Secondary Objective: -To assess the difference in length of stay in ICU when using an analgesia based regimen with remifentanil, as compared with a conventional sedation regimen with propofol. -To demonstrate significant reductions in the use of concomitant sedative agents/opioid e.g. propofol when using an analgesia based regimen with remifentanil, as compared with a conventional sedation regimen with propofol. -To quantify the difference in time taken to extubate a subject when using an analgesia based regimen with remifentanil, as compared with a conventional sedation regimen with propofol. | — |
Countries
Italy
Outcome results
None listed