General Anesthetic Drug Adverse ReactionNCT02617680
Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia
A study testing desflurane - oxygen in air and desflurane - oxygen in nitric oxide in people with General Anesthetic Drug Adverse Reaction, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
There is accumulating evidence that inappropriate depth of anaesthesia is associated with increased risk of postoperative complications including risk of death. The aim of this study was to identify factors determining the effective end-tidal concentration (EEtC) of desflurane, duration of wash in and wash out phase… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- General Anesthetic Drug Adverse Reaction
- What is being tested?
- desflurane - oxygen in air and desflurane - oxygen in nitric oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- Feb 2015to Dec 2015
- Phase
- Interventional
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- elective neurosurgical procedure under general anaesthesia
- Age between 18 and 78
- elective procedures with estimated duration 1 - 3 hours
Who cannot join
- Glasgow coma scale GCS below 14
- other rhythm than sinus
- pacemaker stimulation
- planned postoperative ventilation
Trial locations and contacts
1 site in 1 country.
About this study
There is accumulating evidence that inappropriate depth of anaesthesia is associated with increased risk of postoperative complications including risk of death. The aim of this study was to identify factors determining the effective end-tidal concentration (EEtC) of desflurane, duration of wash in and wash out phase, and to estimate the risk of perioperative awareness in patients undergoing elective neurosurgical procedure.
Read the detailed description
All patients with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective neurosurgical procedure under general anaesthesia are studied. In each individual, the manufacturer recommended age-corrected end-tidal concentrations of desflurane is set and achieved initially. Individual effective end-tidal concentration (EEtC) of desflurane is then defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50. Effective analgesia is maintained according to surgical plethysmographic index (SPI) and dose of muscle relaxants according to neuromuscular transmission monitoring (TOF). Comorbidity, regular intake of alcohol and medication, smoking, sex, weight, height, and age are recorded. Postoperative questionnaire is used to reveal the intraoperative awareness.
- Conditions
- General Anesthetic Drug Adverse Reaction
- Being tested
- desflurane - oxygen in air, desflurane - oxygen in nitric oxide
- Keywords
- Desflurane, end tidal concentration, age, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desflurane - oxygen in airDrug
Also called suprane
The manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Individual EEtC of desflurane will be defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50
desflurane - oxygen in nitric oxideDrug
Also called suprane
The manufacturer recommended age-corrected end-tidal concentrations of desflurane with nitric oxide - oxygen should be set and achieved initially. Individual EEtC of desflurane will be defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50
| Study group | Role | What they receive |
|---|---|---|
| desflurane - oxygen in air | Experimental | The manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Concentration of oxygen should be 50%. Receives: Drug: desflurane - oxygen in air |
| desflurane - oxygen in nitric oxide | Experimental | The manufacturer recommended age-corrected end-tidal concentrations of desflurane with nitric oxide - oxygen should be set and achieved initially.Concentration of oxygen should be 50%. Receives: Drug: desflurane - oxygen in nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
end tidal concentration of desflurane according to age
Measured: from the start of procedure up to 4 hours
Secondary outcomes (5)
Time to spontaneous ventilation
Measured: from end of anesthesia up to 1 hour
Time to extubation
Measured: from the end of anesthesia up to 1 hour
Time to reaction to command
Measured: from the end of anesthesia up to 1 hour
Wash in phase
sec
Measured: up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes
Wash out phase
Measured: from the end of procedure up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthetic Drug Adverse ReactionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Vlasta Dostalova, MD., Ph.D., Principal investigator, University Hospital Hradec Kralove, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617680
- Sponsor's protocol ID
- 201404515P
- Status last verified
- Oct 2016
- First submitted
- 15 Nov 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Effective End-tidal Concentration of Desflurane Anaesthesia
- ClinicalTrials.gov ID
- NCT02617680
- Acronym / sponsor ID
- 201404515P
- Conditions
- General Anesthetic Drug Adverse Reaction
- Keywords
- Desflurane, end tidal concentration, age, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Dec 2015 (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.
There is accumulating evidence that inappropriate depth of anaesthesia is associated with increased risk of postoperative complications including risk of death. The aim of this study was to identify factors determining the effective end-tidal concentration (EEtC) of desflurane, duration of wash in and wash out phase, and to estimate the risk of perioperative awareness in patients undergoing elective neurosurgical procedure.
Detailed description
All patients with American Society of Anesthesiologists (ASA) physical status I-III scheduled for elective neurosurgical procedure under general anaesthesia are studied. In each individual, the manufacturer recommended age-corrected end-tidal concentrations of desflurane is set and achieved initially. Individual effective end-tidal concentration (EEtC) of desflurane is then defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50. Effective analgesia is maintained according to surgical plethysmographic index (SPI) and dose of muscle relaxants according to neuromuscular transmission monitoring (TOF). Comorbidity, regular intake of alcohol and medication, smoking, sex, weight, height, and age are recorded. Postoperative questionnaire is used to reveal the intraoperative awareness.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| desflurane - oxygen in air | Experimental | Drug: desflurane - oxygen in airThe manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Concentration of oxygen should be 50%. |
| desflurane - oxygen in nitric oxide | Experimental | Drug: desflurane - oxygen in nitric oxideThe manufacturer recommended age-corrected end-tidal concentrations of desflurane with nitric oxide - oxygen should be set and achieved initially.Concentration of oxygen should be 50%. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III
- elective neurosurgical procedure under general anaesthesia
- Age between 18 and 78
- elective procedures with estimated duration 1 - 3 hours
Key exclusion criteria (4 listed)
- Glasgow coma scale GCS below 14
- other rhythm than sinus
- pacemaker stimulation
- planned postoperative ventilation
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 |
|---|---|---|
| desflurane - oxygen in airAlso: supraneThe manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Individual EEtC of desflurane will be defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50 | Drug | desflurane - oxygen in air |
| desflurane - oxygen in nitric oxideAlso: supraneThe manufacturer recommended age-corrected end-tidal concentrations of desflurane with nitric oxide - oxygen should be set and achieved initially. Individual EEtC of desflurane will be defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50 | Drug | desflurane - oxygen in nitric oxide |
Primary outcome
end tidal concentration of desflurane according to age
Time frame: from the start of procedure up to 4 hours
5 secondary outcomes
Time to spontaneous ventilation
Time frame: from end of anesthesia up to 1 hour
Time to extubation
Time frame: from the end of anesthesia up to 1 hour
Time to reaction to command
Time frame: from the end of anesthesia up to 1 hour
Wash in phase
Time frame: up to achievement of manufacturer age-corrected end-tidal concentrations of desflurane up to 10 minutes
Wash out phase
Time frame: from the end of procedure up to 1 hour
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 18 Oct 2016.
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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.
Vlasta Dostalova, MD., Ph.D. principal investigator
University Hospital Hradec Kralove, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing desflurane - oxygen in air and desflurane - oxygen in nitric oxide in people with General Anesthetic Drug Adverse Reaction, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 4 inclusion and 4 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
end tidal concentration of desflurane according to age (time frame: from the start of procedure up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2016.