A randomised, double-blinded, multicentre, parallel group study comparing a remifentanil-regimen with a fentanyl-regimen for analgesia in mechanically ventilated patients

Not Applicable

Completed

• Conditions: Analgesia in mechanical ventilation; Signs and Symptoms; Analgesia

• Registration Number: ISRCTN45716767
• Lead Sponsor: Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-03
• Study Completion: 2009-06-30
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Need for Intensive Care Unit (ICU) treatment because of at least one severe illness
2. Expected mechanical ventilation duration greater than 24 hours
3. Present mechanical ventilation duration less than 48 hours
4. Aged greater than 18 years

Exclusion Criteria

1. Expected ICU therapy less than 24 hours
2. Present mechanical ventilation duration greater than 48 hours
3. Expected ventilation duration greater than 24 hours
4. Pregnancy
5. Expected limited cerebral or neurological ability caused by:
5.1. Hypoxic brain damage
5.2. Severe traumatic brain injury
5.3. Cranial mass bleeding
5.4. Dementia
5.5. Parkinson's disease
5.6. Motor Neuron Disease
6. Myasthenia gravis
7. Need for chronical artificial ventilation
8. Chronic-pain patients (World Health Organization [WHO] grade III)
9. Patients with spinal anaesthesia
10. Peridural anaesthesia with opioids
11. Patients with severe illnesses (American Society of Anaesthesiologists [ASA] grade V)
12. Patients who took part on other studies the last 30 days
13. No permission for study treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> According to the different analgetic treatment the target values of sedation and analgesia must be reached. The following endpoints will be measured every hour for the first 6 hours after the start of the study drug, then every 4 hours for the first 24 hours after the start of the study drug. Thereafter every 8 hours until the end of the study (maximum 30 days):<br> 1. Richmond Agitation Sedation Scale (RASS)<br> 2. Behavioural Pain Scale (BPS)<br> 3. Visual Analogue Scale (VAS)<br> 4. Delirium Detection Scale (DDS)<br>