Airway ExtubationNCT01513772
The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery
A study testing Dexmedetomidine and Normal saline 0.9% in people with Airway Extubation, run by Severance Hospital at 1 site in South Korea.
Trial summary
The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Airway Extubation
- What is being tested?
- Dexmedetomidine and Normal saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to Aug 2012
- 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 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age ≥ 20,
- ASA class I and II,
- nasal surgery
Who cannot join
- bradycardia (< 45 bpm),
- heart block,
- liver failure,
- renal failure,
- uncontrolled hypertension,
- body mass index ≥ 30 kg/m2
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul
About this study
The investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery
Read the detailed description
Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery.
- Conditions
- Airway Extubation
- Being tested
- Dexmedetomidine, Normal saline 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation
Normal saline 0.9%Drug
Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Normal saline 0.9% |
| Dexmedetomidine | Active comparator | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation
Measured: 20min
Secondary outcomes (1)
Postoperative quality of recovery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513772
- Sponsor's protocol ID
- 4-2011-0742
- Status last verified
- Aug 2012
- First submitted
- 16 Jan 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on the Emergence Agitation in Nasal Surgery
- ClinicalTrials.gov ID
- NCT01513772
- Acronym / sponsor ID
- 4-2011-0742
- Conditions
- Airway Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Jan 2012 (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 investigators examined the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in nasal surgery
Detailed description
Emergence agitation during the immediate postanesthetic period is common. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters. Emergence agitation is common in ENT surgery. The aim of this study is to evaluate the effect of dexmedetomidine on the emergence agitation and postoperative quality of recovery in adult patients undergoing nasal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Normal saline 0.9% |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age ≥ 20,
- ASA class I and II,
- nasal surgery
Key exclusion criteria (6 listed)
- bradycardia (< 45 bpm),
- heart block,
- liver failure,
- renal failure,
- uncontrolled hypertension,
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation | Drug | Dexmedetomidine |
| Normal saline 0.9%Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation | Drug | Control |
Primary outcome
Emergence agitation
Time frame: 20min
1 secondary outcome
Postoperative quality of recovery
Time frame: 1 day
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 9 Aug 2012.
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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 study testing Dexmedetomidine and Normal saline 0.9% in people with Airway Extubation, run by Severance 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 3 inclusion and 6 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 9 Aug 2012. 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. Some participants in this study may receive a placebo. 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?
Emergence agitation (time frame: 20min). 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 9 Aug 2012.