A randomised, double-blinded, multicentre, parallel group study comparing a remifentanil-regimen with a fentanyl-regimen for analgesia in mechanically ventilated patients
| ISRCTN | ISRCTN45716767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45716767 |
| EudraCT/CTIS number | 2005-001907-21 |
| Secondary identifying numbers | 911 |
- Submission date
- 09/07/2007
- Registration date
- 03/10/2007
- Last edited
- 19/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudia Spies
Scientific
Scientific
Chariteplatz 1
Berlin
10117
Germany
| Phone | +49 (0)30 450 531 012/52 |
|---|---|
| claudia.spies@charite.de |
Study information
| Study design | Randomised controlled double-blind parallel-group multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised, double-blinded, multicentre, parallel group study comparing a remifentanil-regimen with a fentanyl-regimen for analgesia in mechanically ventilated patients |
| Study acronym | ZORA |
| Study objectives | There is a difference in analgetic quality and controllability between remifentanil and fentanyl. Please note that, as of 08/01/09, the anticipated end date of this trial has been updated from 01/12/2008 to 30/06/2009. |
| Ethics approval(s) | 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). |
| Health condition(s) or problem(s) studied | Analgesia in mechanical ventilation |
| Intervention | 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 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Remifentanil, fentanyl |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 01/11/2005 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Chariteplatz 1
Berlin
10117
Germany
10117
Germany
Sponsor information
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Universitatsklinik fur Anasthesiologie und operative Intensivmedizin
Klinikdirektorin: Prof. C. Spies
Augustenburger Platz 1
Berlin
13353
Germany
| Website | http://www.charite.de/ch/anaest/ |
|---|---|
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Industry
GlaxoSmithKline Beecham (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 03/09/2020 | 19/05/2022 | No | No |
Editorial Notes
19/05/2022: EU Clinical Trials Register results added.
