Recovery From SedationNCT00586118
Inhalative Sedation in ICU With Sevoflurane Via Anaesthetic Conserving Device Compared to Propofol
An observational study of Recovery From Sedation and Sevoflurane Consumption, run by Klinikum Ludwigshafen.
Trial summary
The evaluation of the presented study will work on the practicability of inhalative sedation on the ICU, potential benefits and limitations of the ACD system in a postoperative sedated patient population in comparison to a standard intravenous sedation regimen with propofol, and focus on renal and hepatic function… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Recovery From Sedation, Sevoflurane Consumption, Renal Function
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120 patients, scheduled for elective major surgery and postoperative admission to the ICU, are screened the day before surgery for potential in- and exclusion criteria.
Who may be able to join
- 18-80 years
- elective operative procedure, and indication for admission to the ICU for postoperative sedation
- ASA I-III
- weight 50-120 kg
- Haemoglobin > 10 g/dl
- ability and acceptance to agree to the study participation
Who cannot join
- malignant hyperthermia
- muscle diseases or weakness
- liver insufficiency (ASAT, ALAT > 40 U/min)
- pancreas insufficiency
- emergencies
- women in child bearing age and missing negative pregnancy test, pregnancy or lactation
Show all 13Show fewer
- diseases from the central nervous system (such as M. Parkinson and multiple sclerosis)
- increased intracranial pressure, head trauma
- pre-existing delirium, agitation and psychiatric derangements
- alcohol and drug abuse (including opioid abuse)
- allergy to any of the study agents
- refusal from the patient to participate in the study
- participation in another study project.
About this study
The evaluation of the presented study will work on the practicability of inhalative sedation on the ICU, potential benefits and limitations of the ACD system in a postoperative sedated patient population in comparison to a standard intravenous sedation regimen with propofol, and focus on renal and hepatic function, cardioprotection and pharmacoeconomics
Read the detailed description
A goal-oriented sedation complies the ability to sedate the patient as deeply as necessary, and allow a modern ventilation regimen with early spontaneous breathing and a pain-free cooperative patient. The ideal sedative agent - with a short duration of action, predictable wake-up times, low drug toxicity, haemodynamic stability and less side effects, and a rational pharmacoeconomic impact nowadays - has still to be found. Inhalative anaesthetics show these properties, but until the introduction of AnaConDa© (Anesthetic Conserving Device, ACD) in 2005, the use of volatile anaesthetics on the intensive care unit (ICU) required specific evaporating devices or scavenging systems. The ACD, a modified heat- moisture filter, is connected to the breathing circuit of conventional ICU ventilators and a syringe pump delivers the volatile anaesthetic to the ACD where it is vaporized through a rod. Most of the exhaled gas is absorbed in a charcoal filter's membrane and reflected to the patient in the following inspiration. Randomised, controlled and comparative studies to the use of volatile anaesthetics in ICU via this innovative device are still missing. Isoflurane has been studied in small patient populations and in comparison to midazolam, while Sevoflurane - a newer volatile agent with short action, brief elimination time, and low hepatic biodegradation - has only been studied intraoperatively and in short-term sedation. This is the first prospective, randomised, clinical study on the feasibility of sevoflurane via the ACD for sedation in ICU patients until 72 hours in comparison to a standard intravenous sedation with propofol. The investigation will work on potential benefits and limitations of the use of volatile agents on the ICU, the quality of sedation (Richmond Agitation Sedation Scale, BIS), infusion rate stability of sevoflurane and respiratory parameters, short-term recovery (time from discontinuation of infusion until following verbal commands and extubation), haemodynamics, renal and hepatic function and adverse side effects.
- Conditions
- Recovery From Sedation, Sevoflurane Consumption, Renal Function, Hepatic Function, Cardioprotection
- Being tested
- Sevoflurane, Propofol
- Keywords
- Sedation, Volatile anaesthetic, Sevoflurane, Propofol, Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane (Abbott GmbH, Wiesbaden, Germany)
Sevoflurane sedation, 0.5-1 Vol%, continuously via syringe pump, up to 72 hours in ICU
PropofolDrug
Also called disoprivan
Propofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours
| Study group | Role | What they receive |
|---|---|---|
| 1-Sevo | Sevoflurane/ACD group (n=60) Receives: Drug: Sevoflurane | |
| 2-Propofol | Propofol group (n=60) Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time
Measured: Termination of sedation to extubation
Secondary outcomes (5)
Consumption of anaesthetics
Measured: until discharge from hospital
Renal function
Measured: until discharge from hospital
Hepatic function
Measured: until discharge from hospital
Cardioprotection
Measured: until discharge from hospital
Costs
Measured: until discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Recovery From SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Ludwigshafen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsmedizin Mannheim
- Investigators
- Kerstin D. Röhm, Dr. med., Principal investigator, Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586118
- Sponsor's protocol ID
- ANA06104
- Other IDs
- ANA06104
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 4 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Sackey PV, Martling CR, Nise G, Radell PJ. Ambient isoflurane pollution and isoflurane consumption during intensive care unit sedation with the Anesthetic Conserving Device. Crit Care Med. 2005 Mar;33(3):585-90. doi: 10.1097/01.ccm.0000156294.92415.e2.
PubMed 15753751Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6. doi: 10.1097/01.ccm.0000145951.76082.77.
PubMed 15640636Berton J, Sargentini C, Nguyen JL, Belii A, Beydon L. AnaConDa reflection filter: bench and patient evaluation of safety and volatile anesthetic conservation. Anesth Analg. 2007 Jan;104(1):130-4. doi: 10.1213/01.ane.0000248221.44383.43.
PubMed 17179257
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalative Sedation in ICU With Sevoflurane Via Anaesthetic Conserving Device Compared to Propofol
- ClinicalTrials.gov ID
- NCT00586118
- Acronym / sponsor ID
- ANA06104
- Conditions
- Recovery From Sedation, Sevoflurane Consumption, Renal Function, Hepatic Function, Cardioprotection
- Keywords
- Sedation, Volatile anaesthetic, Sevoflurane, Propofol, Recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Klinikum LudwigshafenUniversity, hospital or other
- Collaborators
- Universitätsmedizin Mannheim
- Study start
- Dec 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The evaluation of the presented study will work on the practicability of inhalative sedation on the ICU, potential benefits and limitations of the ACD system in a postoperative sedated patient population in comparison to a standard intravenous sedation regimen with propofol, and focus on renal and hepatic function, cardioprotection and pharmacoeconomics
Detailed description
A goal-oriented sedation complies the ability to sedate the patient as deeply as necessary, and allow a modern ventilation regimen with early spontaneous breathing and a pain-free cooperative patient. The ideal sedative agent - with a short duration of action, predictable wake-up times, low drug toxicity, haemodynamic stability and less side effects, and a rational pharmacoeconomic impact nowadays - has still to be found. Inhalative anaesthetics show these properties, but until the introduction of AnaConDa© (Anesthetic Conserving Device, ACD) in 2005, the use of volatile anaesthetics on the intensive care unit (ICU) required specific evaporating devices or scavenging systems. The ACD, a modified heat- moisture filter, is connected to the breathing circuit of conventional ICU ventilators and a syringe pump delivers the volatile anaesthetic to the ACD where it is vaporized through a rod. Most of the exhaled gas is absorbed in a charcoal filter's membrane and reflected to the patient in the following inspiration. Randomised, controlled and comparative studies to the use of volatile anaesthetics in ICU via this innovative device are still missing. Isoflurane has been studied in small patient populations and in comparison to midazolam, while Sevoflurane - a newer volatile agent with short action, brief elimination time, and low hepatic biodegradation - has only been studied intraoperatively and in short-term sedation. This is the first prospective, randomised, clinical study on the feasibility of sevoflurane via the ACD for sedation in ICU patients until 72 hours in comparison to a standard intravenous sedation with propofol. The investigation will work on potential benefits and limitations of the use of volatile agents on the ICU, the quality of sedation (Richmond Agitation Sedation Scale, BIS), infusion rate stability of sevoflurane and respiratory parameters, short-term recovery (time from discontinuation of infusion until following verbal commands and extubation), haemodynamics, renal and hepatic function and adverse side effects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Sevo | – | Drug: SevofluraneSevoflurane/ACD group (n=60) |
| 2-Propofol | – | Drug: PropofolPropofol group (n=60) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 patients, scheduled for elective major surgery and postoperative admission to the ICU, are screened the day before surgery for potential in- and exclusion criteria.
Key inclusion criteria (6 listed)
- 18-80 years
- elective operative procedure, and indication for admission to the ICU for postoperative sedation
- ASA I-III
- weight 50-120 kg
- Haemoglobin > 10 g/dl
Key exclusion criteria (13 listed)
- malignant hyperthermia
- muscle diseases or weakness
- liver insufficiency (ASAT, ALAT > 40 U/min)
- pancreas insufficiency
- emergencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: Sevorane (Abbott GmbH, Wiesbaden, Germany)Sevoflurane sedation, 0.5-1 Vol%, continuously via syringe pump, up to 72 hours in ICU | Drug | 1-Sevo |
| PropofolAlso: disoprivanPropofol, 1.5-3 mg/kgBW/h, continuously via syringe pump, up to 72 hours | Drug | 2-Propofol |
Primary outcome
Extubation time
Time frame: Termination of sedation to extubation
5 secondary outcomes
Consumption of anaesthetics
Time frame: until discharge from hospital
Renal function
Time frame: until discharge from hospital
Hepatic function
Time frame: until discharge from hospital
Cardioprotection
Time frame: until discharge from hospital
Costs
Time frame: until discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2008.
- Background: PubMed 15753751Sackey PV, Martling CR, Nise G, Radell PJ. Ambient isoflurane pollution and isoflurane consumption during intensive care unit sedation with the Anesthetic Conserving Device. Crit Care Med. 2005 Mar;33(3):585-90. doi: 10.1097/01.ccm.0000156294.92415.e2.
- Background: PubMed 15640636Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6. doi: 10.1097/01.ccm.0000145951.76082.77.
- Background: PubMed 17179257Berton J, Sargentini C, Nguyen JL, Belii A, Beydon L. AnaConDa reflection filter: bench and patient evaluation of safety and volatile anesthetic conservation. Anesth Analg. 2007 Jan;104(1):130-4. doi: 10.1213/01.ane.0000248221.44383.43.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerstin D. Röhm, Dr. med. principal investigator
Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Recovery From Sedation and Sevoflurane Consumption, run by Klinikum Ludwigshafen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation time (time frame: Termination of sedation to extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00586118, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2008.