Condition category
Signs and Symptoms
Date applied
09/07/2007
Date assigned
03/10/2007
Last edited
08/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claudia Spies

ORCID ID

Contact details

Chariteplatz 1
Berlin
10117
Germany
+49 (0)30 450 531 012/52
claudia.spies@charite.de

Additional identifiers

EudraCT number

2005-001907-21

ClinicalTrials.gov number

Protocol/serial number

911

Study information

Scientific title

Acronym

ZORA

Study hypothesis

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

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).

Study design

Randomised controlled double-blind parallel-group multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Remifentanil, fentanyl

Primary outcome measures

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 trial start date

01/11/2005

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant 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

Recruitment start date

01/11/2005

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Chariteplatz 1
Berlin
10117
Germany

Sponsor information

Organisation

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Sponsor details

Universitatsklinik fur Anasthesiologie und operative Intensivmedizin
Klinikdirektorin: Prof. C. Spies
Augustenburger Platz 1
Berlin
13353
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.charite.de/ch/anaest/

Funders

Funder type

Industry

Funder name

GlaxoSmithKline Beecham (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes