Deep ExtubationPhase 4NCT01924871
Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia
A Phase 4 study testing Desflurane with remifentanil and Desflurane in people with Deep Extubation, run by Chung-Ang University Hospital at 1 site in South Korea.
Trial summary
It has been reported that deep extubation can reduce cardiopulmonary complication against endotracheal tube extubation during emergence from general anesthesia. The investigators hypothesized that using desflurane with target controlled infusion of remifentanil is more effective than using desflurane alone during deep… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Deep Extubation
- What is being tested?
- Desflurane with remifentanil and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-60
- patients undergoing elective surgery take more than an hour
- Under general anesthesia using an LMA
- ASA I,II
Who cannot join
- Patients on CNS depressants
- Chronic opioid use
- Corticosteroid
- Pregnant patients
- Full stomach
- Morbidly obese (BMI >35kg/m2)
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- Hepatitis B
- Hepatitis C
- Coronary artery disease
- Liver disease
- Renal disease
- Seizure disorder
- Dropout criteria:
- Need for reintubation due to breath holding
- high ETCO2 during self ventilation (ETCO2>50)
- Surgeon or patient request
Trial locations and contacts
1 site in 1 country.
About this study
It has been reported that deep extubation can reduce cardiopulmonary complication against endotracheal tube extubation during emergence from general anesthesia. The investigators hypothesized that using desflurane with target controlled infusion of remifentanil is more effective than using desflurane alone during deep extubation. The purpose of this study is to evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing) during emergence from general anesthesia.
- Conditions
- Deep Extubation
- Being tested
- Desflurane with remifentanil, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desflurane with remifentanilDrug
Also called desflurane with remifetanil group
During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil
DesfluraneDrug
Also called Desflurane alone group
During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane
| Study group | Role | What they receive |
|---|---|---|
| Desflurane group | Active comparator | 1.5 MAC desflurane until extubation Receives: Drug: Desflurane |
| Desflurane with remifentanil group | Active comparator | 1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil Receives: Drug: Desflurane with remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awakening Time
The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening
Measured: Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.
Secondary outcomes (1)
Success Rate & Complication Rate Including Cough
We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia.
Measured: assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deep ExtubationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chongwha Baek, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924871
- Sponsor's protocol ID
- deep extubation in CAUH
- Status last verified
- Apr 2014
- First submitted
- 12 Aug 2013
- Last updated
- 7 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Deep Extubation During Emergence Using Desflurane or Desflurane With Remifentanil in Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT01924871
- Acronym / sponsor ID
- deep extubation in CAUH
- Conditions
- Deep Extubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been reported that deep extubation can reduce cardiopulmonary complication against endotracheal tube extubation during emergence from general anesthesia. The investigators hypothesized that using desflurane with target controlled infusion of remifentanil is more effective than using desflurane alone during deep extubation. The purpose of this study is to evaluate the effect of remifentanil to prevent respiratory complication (etc. coughing) during emergence from general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane group | Active comparator | Drug: Desflurane1.5 MAC desflurane until extubation |
| Desflurane with remifentanil group | Active comparator | Drug: Desflurane with remifentanil1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-60
- patients undergoing elective surgery take more than an hour
- Under general anesthesia using an LMA
- ASA I,II
Key exclusion criteria (16 listed)
- Patients on CNS depressants
- Chronic opioid use
- Corticosteroid
- Pregnant patients
- Full stomach
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 with remifentanilAlso: desflurane with remifetanil groupDuring the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil | Drug | Desflurane with remifentanil group |
| DesfluraneAlso: Desflurane alone groupDuring the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane | Drug | Desflurane group |
Primary outcome
Awakening Time
Time frame: Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.
The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening
1 secondary outcome
Success Rate & Complication Rate Including Cough
Time frame: assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desflurane with remifentanil and Desflurane in people with Deep Extubation, run by Chung-Ang University Hospital at 1 site in South Korea.
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 16 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 7 May 2014. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Awakening Time (time frame: Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.). 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 7 May 2014.