search
Back to results

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

Primary Purpose

Analgesia, Sedation

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Sufentanil
Remifentanil
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring remifentanil, sufentanil, propofol, analgesia, sedation, mechanically ventilated, intensive care, pharmacoeconomic, weaning, delirium, randomized, Germany

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  • Written informed consent was obtained from the patient
  • The patient is under intensive medical care, intubated and ventilated
  • The expected duration of ventilation and analgesia/sedation is > 24 hours and </= 7 days
  • Propofol is planned to be used as sedative

EXCLUSION CRITERIA

  • Contraindication against administration of remifentanil, sufentanil, or propofol
  • Concomitant medications:
  • The patient is receiving epidural analgesia or a peripheral regional anesthetic therapy.
  • The patient is requiring muscle relaxants to facilitate mechanical ventilation
  • The patient participated in clinical drug trials within the previous 30 days or participated in this clinical trial before or is currently participating in any other clinical trial
  • The patient has a known hypersensitivity to the drugs under investigation or to propofol (and other components of the preparation to be used), soy and peanut
  • For female patients: the patient is pregnant or breastfeeding
  • The patient is classified as ASA V or moribund
  • The patient must be expected to show an impaired cerebral or neurologic capacity due to illness, trauma or other interventions, which will interfere with the collection of the analgesia/sedation scores and the waking behavior as for example, without being limited to:
  • Hypoxic brain damage
  • Cerebrocranial trauma grades II, III, and IV
  • Subarachnoid hemorrhage, brain-stem hemorrhage, ischemic-hemorrhagic cerebral hemorrhages
  • Amyotrophic lateral sclerosis, myasthenia gravis
  • Stupor or coma
  • The patient requires chronic ventilation
  • The patient is receiving chronic (> 3 months) therapy with high-potency opioids/WHO level 3
  • The patient is alcohol or drug dependent (legal or illegal drugs in particular, but not exclusively with dependency on sedatives or benzodiazepines), defined as:
  • Typically an urgent desire to take the substance, problems in controlling consumption, and persistent use of the substance despite adverse consequences. The use of the substance has priority over other activities and responsibilities. Developing increased tolerance and occasionally physical withdrawal symptom.
  • The patient suffers from a manifest organ failure
  • The patient suffers from severe heart failure, NYHA Class IV (symptoms at rest)
  • The patient has a history of or actually suffers from ventricular tachycardia, ventricular flutter or ventricular fibrillation

Sites / Locations

  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
January 11, 2007
Last Updated
March 30, 2018
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00421720
Brief Title
A Study Comparing Two Analgesia/Sedation Regimens, Remifentanil/Propofol Versus Sufentanil/Propofol In Mechanically Ventilated Intensive Care Patients Requiring Analgesia And Sedation.
Official Title
A Randomized, Open-label, Multicenter, Parallel-group Study to Compare the Efficacy, Safety and Resource Utilization of a Remifentanil/Propofol Analgesia/Sedation Regimen Versus a Sufentanil/Propofol Analgesia/Sedation Regimen in Mechanically Ventilated Intensive Care Patients Requiring Analgesia and Sedation for up to 7 Days
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Sedation
Keywords
remifentanil, sufentanil, propofol, analgesia, sedation, mechanically ventilated, intensive care, pharmacoeconomic, weaning, delirium, randomized, Germany

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Written informed consent was obtained from the patient The patient is under intensive medical care, intubated and ventilated The expected duration of ventilation and analgesia/sedation is > 24 hours and </= 7 days Propofol is planned to be used as sedative EXCLUSION CRITERIA Contraindication against administration of remifentanil, sufentanil, or propofol Concomitant medications: The patient is receiving epidural analgesia or a peripheral regional anesthetic therapy. The patient is requiring muscle relaxants to facilitate mechanical ventilation The patient participated in clinical drug trials within the previous 30 days or participated in this clinical trial before or is currently participating in any other clinical trial The patient has a known hypersensitivity to the drugs under investigation or to propofol (and other components of the preparation to be used), soy and peanut For female patients: the patient is pregnant or breastfeeding The patient is classified as ASA V or moribund The patient must be expected to show an impaired cerebral or neurologic capacity due to illness, trauma or other interventions, which will interfere with the collection of the analgesia/sedation scores and the waking behavior as for example, without being limited to: Hypoxic brain damage Cerebrocranial trauma grades II, III, and IV Subarachnoid hemorrhage, brain-stem hemorrhage, ischemic-hemorrhagic cerebral hemorrhages Amyotrophic lateral sclerosis, myasthenia gravis Stupor or coma The patient requires chronic ventilation The patient is receiving chronic (> 3 months) therapy with high-potency opioids/WHO level 3 The patient is alcohol or drug dependent (legal or illegal drugs in particular, but not exclusively with dependency on sedatives or benzodiazepines), defined as: Typically an urgent desire to take the substance, problems in controlling consumption, and persistent use of the substance despite adverse consequences. The use of the substance has priority over other activities and responsibilities. Developing increased tolerance and occasionally physical withdrawal symptom. The patient suffers from a manifest organ failure The patient suffers from severe heart failure, NYHA Class IV (symptoms at rest) The patient has a history of or actually suffers from ventricular tachycardia, ventricular flutter or ventricular fibrillation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD, PhD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Saarbrucken
ZIP/Postal Code
66119
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Tubingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs