A randomized, open label, multicentre study to compare the pharmaco-economic implications of an analgesia based regimen with remifentanil and a conventional sedation based regimen using propofol in medical and post-surgical ICU subjects requiring mechanical ventilation for at least 2 days. - ND

• Conditions: Medical and post surgical ICU patient requiring analgesia and sedation.; MedDRA version: 6.1Level: PTClassification code 10039897

• Registration Number: EUCTR2006-004204-39-IT
• Lead Sponsor: GLAXO SMITHKLINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 196

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified