AgitationPhase 4NCT01524367
Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
A Phase 4 study testing saline and Dexmedetomidine in people with Agitation, run by Yonsei University at 1 site in South Korea.
Trial summary
Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Agitation
- What is being tested?
- saline and Dexmedetomidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Jan 2013
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status 1 or 2 patients
- patients scheduled for orthognathic surgery (two-jaw)
Who cannot join
- severe cardiovascular disease
- allergy to dexmedetomidine
- psychological disease
- patients who cannot understand Korean
Trial locations and contacts
1 site in 1 country.
About this study
Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. It has been reported that the incidence of postoperative emergence excitement in adults after general anesthesia is 21.3% occurrence.
Many things are mentioned as risk factors for emergence excitement. Among them, excitement after orthognathic surgery (two-jaw) was more common than after other types of surgery. The patients undergoing emergence with nasotracheal intubation after orthognathic surgery may have a sense of suffocation during emergence from anesthesia, which may increase the incidence of emergence excitement.
Read more
Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1) compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.
To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement was investigated only in children.
The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence and the severity of the emergence excitement in adults with nasotracheal intubation after orthognathic surgery (two-jaw).
- Conditions
- Agitation
- Being tested
- saline, Dexmedetomidine
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salineDrug
Also called normal saline
We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.
DexmedetomidineDrug
Also called Precedex
We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.
| Study group | Role | What they receive |
|---|---|---|
| saline group | Placebo comparator | We administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing. Receives: Drug: saline |
| dexmedetomidine group | Experimental | We administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of emergence excitement based on Richmond agitation-sedation scale
The severity of emergence excitement will be measured up to 10 minutes after extubation based on Richmond agitation-sedation(time of eye opening on command, time of leaving the operation room, 5 minutes after arriving post anesthetic recovery room, 10 minutes after extubation).
Measured: Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours.
Secondary outcomes (2)
emergence time
The emergence time will be recorded as the time from desflurane discontinue to eye opening on command.
Measured: up to the time of eye opening,an expected average of 30 minutes.
coughing grade
The coughing grade will be measured up to the time of leaving the postanesthetic recovery room.
Measured: up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yon Hee Shim, Yonsei University
- Investigators
- Yonhee Shim, Study director, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524367
- Sponsor's protocol ID
- 3-2011-0200
- Status last verified
- Feb 2015
- First submitted
- 28 Oct 2011
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single-dose Dexmedetomidine on Emergence Excitement in Adults With Nasotracheal Intubation After Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT01524367
- Acronym / sponsor ID
- 3-2011-0200
- Conditions
- Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Feb 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.
Excitement during the emergence from general anesthesia is a great post-operative problem. It may lead to serious consequences for the patient, such as injury, increased pain, hemorrhage, self-extubation, and removal of catheters, and it can necessitate physically or chemically restraining the patient. It has been reported that the incidence of postoperative emergence excitement in adults after general anesthesia is 21.3% occurrence.
Many things are mentioned as risk factors for emergence excitement. Among them, excitement after orthognathic surgery (two-jaw) was more common than after other types of surgery. The patients undergoing emergence with nasotracheal intubation after orthognathic surgery may have a sense of suffocation during emergence from anesthesia, which may increase the incidence of emergence excitement.
Pain is also a main cause of postoperative excitement. Dexmedetomidine, which is an S-enantiomer of medetomidine with high specificity for α2-adrenoceptor (α2 : α1, 1620 : 1) compared to clonidine (a2 : a1, 220 : 1), is approved as a sedative and co-analgesic drug.
To the best of the investigators knowledge, effect of dexmedetomidine on emergence excitement was investigated only in children.
The investigators hypothesized that single dose of dexmedetomidine would reduce the incidence and the severity of the emergence excitement in adults with nasotracheal intubation after orthognathic surgery (two-jaw).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline group | Placebo comparator | Drug: salineWe administrate the saline single bolus (0.01ml/kg,intravenously) at time of oral cavity sealing. |
| dexmedetomidine group | Experimental | Drug: DexmedetomidineWe administrate the dexmedetomidine single bolus (1ug/kg, intravenously) at time of oral cavity sealing. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status 1 or 2 patients
- patients scheduled for orthognathic surgery (two-jaw)
Key exclusion criteria (4 listed)
- severe cardiovascular disease
- allergy to dexmedetomidine
- psychological disease
- patients who cannot understand Korean
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 |
|---|---|---|
| salineAlso: normal salineWe administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing. | Drug | saline group |
| DexmedetomidineAlso: PrecedexWe administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing. | Drug | dexmedetomidine group |
Primary outcome
severity of emergence excitement based on Richmond agitation-sedation scale
Time frame: Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 hours.
The severity of emergence excitement will be measured up to 10 minutes after extubation based on Richmond agitation-sedation(time of eye opening on command, time of leaving the operation room, 5 minutes after arriving post anesthetic recovery room, 10 minutes after extubation).
2 secondary outcomes
emergence time
Time frame: up to the time of eye opening,an expected average of 30 minutes.
coughing grade
Time frame: up to the time of leaving the postanesthetic recovery room,an expected average of 2 hours.
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 6 Feb 2015.
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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.
Yonhee Shim study director
Yonsei University
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 saline and Dexmedetomidine in people with Agitation, run by Yonsei University 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 2 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 6 Feb 2015. 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.
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?
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?
severity of emergence excitement based on Richmond agitation-sedation scale (time frame: Patients will be followed for the duration of stay in operation room and post anesthetic recovery room, an expected average of 2 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 6 Feb 2015.