A Study Comparing Two Analgesia/Sedation Regimens, Remifentanil/Propofol Versus Sufentanil/Propofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation.

Phase 4

Terminated

• Conditions: Analgesia; Sedation

• Registration Number: NCT00421720
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This prospective, randomized, multicenter, open-label study will compare two analgesia-based regimens for sedation (remifentanil/propofol vs. sufentanil/propofol) in medium to long-term ventilated intensive care patients in terms of efficacy, safety and resource utilization.

The special characteristics of intensive care patients (organ insufficiencies etc.) regularly cause an accumulation of the analgesics, sedatives and adjuvants used. Clinically, this complicates the calculation of weaning and extubation times, often making mechanical ventilation necessary for longer periods than desired and also extending the stay of patients in the intensive care unit. Reducing weaning times and the duration of intensive care treatment by optimizing analgesia/sedation could furthermore lead to a reduction in typical complications such as ventilator-associated pneumonia or delirium.

The demands on an ideal analgesic are analgesic efficacy without severe cardiopulmonary depression and rapid onset of effect and in particular a short dura-tion of effect and absence of accumulation or development of active metabolites. Remifentanil is an ultra-short acting µ-agonist which is, due to its molecular structure, metabolized organ-independently by unspecific blood and tissue esterases with the substance being degraded within only a few minutes and the resulting metabolites being virtually ineffective at the µ-receptor. Sufentanil, on the other hand, is mainly metabolized by the cytochrome P-450-3A4 enzyme in the liver and small intestine.

To date, only one study with a small sample size is available on the comparison of the effectiveness and safety of remifentanil and sufentanil when used for long-term analgesia/sedation.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-11
• Study First Submitted QC: 2007-01-11
• Study First Posted: 2007-01-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of ventilation and weaning times: - Time from initiation of analgesia/sedation using the investigational substance and extubation ("ventilation time") - Time from the start of weaning to extubation ("weaning time")

Secondary Outcome Measures

Name	Time	Method
ICU length of stay; accuracy of analgesia/sedation; drug consumption of analgesics/sedatives; clinical course; incidence of pneumonia/delirium; infection markers; bowel movement; ventilation parameters; vital signs; resource utilization; safety

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇩🇪 Tubingen, Germany