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

• Register: ISRCTN
• Last refreshed on: 30 May 2022
• Main ID: ISRCTN45716767
• Date of registration: 03/10/2007
• Prospective Registration: No
• Primary sponsor: Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
• Public title: A randomised, double-blinded, multicentre, parallel group study comparing a remifentanil-regimen with a fentanyl-regimen for analgesia in mechanically ventilated patients
• Scientific title: A randomised, double-blinded, multicentre, parallel group study comparing a remifentanil-regimen with a fentanyl-regimen for analgesia in mechanically ventilated patients
• Date of first enrolment: 01/11/2005
• Target sample size: 160
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN45716767
• Study type: Interventional
• Study design: Randomised controlled double-blind parallel-group multi-centre trial (Treatment)
• Phase: Not Specified

Countries of recruitment

Germany

Contacts

• Name: Claudia Spies

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Analgesia in mechanical ventilation
Signs and Symptoms
Analgesia

Intervention(s)

In this study the effectiveness and quality of two different analgesia regimes in mechanically ventilated patients is compared:
1. Remifentanil (5 mg/50 ml) 0.1 - 0.4 µg/kg/min
2. Fentanyl (1 mg/50 ml) 0.02 - 0.08 µg/kg/min
Duration of the treatment: minimum 24 hours, maximum 30 days
Frequency: continuous intravenous (iv) application
Follow up: on discharge from ICU, after 30 days and from discharge 6 and 12 months

Additional sedation with propofol or midazolam allowed:
Propofol (1000 mg/50 mg) 0.8 - 4 mg/kg/h
Midazolam (90 mg/50 ml) 0.01 - 0.18 mg/kg/h
Frequency: continuous iv application

Primary Outcome(s)

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):
1. Richmond Agitation Sedation Scale (RASS)
2. Behavioural Pain Scale (BPS)
3. Visual Analogue Scale (VAS)
4. Delirium Detection Scale (DDS)

Secondary Outcome(s)

1. On admission: Acute Physiology And Chronic Health Evaluation II (APACHE II) score
2. Continuous:
2.1. Electrocardiogram (ECG)
2.2. Blood pressure
2.3. Heart rate
3. Every 8 hours:
3.1. Patient examination
3.2. Temperature
3.3. Volume balance
4. Daily:
4.1. Laboratory (including Prothrombin Consumption Time [PCT], Red Blood Cell count [RBC], White Blood Cell count [WBC], electrolytes, International Normalised Ratio [INR], Partial Thromboplastin Time [PTT], creatinine, urea, bilirubin)
4.2. ICU Scores (Simplified Acute Physiology Score II [SAPS II], Sequential Organ Failure Assessment [SOFA] score, 28-item Therapeutic Intervention Scoring System [TISS 28] score)
4.3. Ventilation parameter
4.4. Weaning protocol
4.5. Adverse events
4.6. Serious adverse events
4.7. Nosocomial infections
4.8. Duration of mechanical ventilation
4.9. Total dosage of analgetics
4.10. Total dosage of sedatives
5. On discharge from ICU, and 6 and 12 months after discharge:
5.1. Quality of life
5.2. Post Traumatic Stress Disorder (PTSD)

Secondary ID(s)

911

2005-001907-21

Source(s) of Monetary Support

GlaxoSmithKline Beecham (UK)

Ethics review

Status:
Approval date:
Contact:

The local ethics committee (Ethics board committee Berlin, Landesamt fur Gesundheit und Soziales [LaGeSo], Berlin) was informed throughout and gave permission for the performance of this clinical trial on the 25th October 2007 (ref: EA 1/125/05).

Results

• Results available: Yes
• Date Completed: 30/06/2009