AgitationPhase 4EANCT02104297
Effect of Deksmedetomidine and Remifentanil in Extubation Agitation
A Phase 4 study testing deksmedetomidine, Remifentanil and Saline in people with Agitation, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Agitation
- What is being tested?
- deksmedetomidine, Remifentanil and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2014to Jun 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients
Who cannot join
- patients with any sensitivity each drug
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Reyhan Polat
Ankara, 06610
Reyhan Polat, MD, +905326734310, reyhanp9@gmail.com
Reyhan Polat, MD
About this study
Official title: The Effect of Deksmedetomidin and Remifentanil Infusion on Extubation Agitation and Recovery Conditions on Nasal Septoplasty Operation
To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.
Read the detailed description
Nasal septum operation cause agitation because of nasal package. This research aims determine which agent , deksmedetomidine remifentanil or placebo, is more beneficial to the patient.
- Conditions
- Agitation
- Being tested
- deksmedetomidine, Remifentanil, Saline
- Keywords
- Nasal septum operation, agitation
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deksmedetomidineDrug
Also called Precedex
deksmedetomidine infused during operation 0.2 mcg/kg/hour
RemifentanilDrug
Also called Ultiva
Remifentanil infused during operation 0.2 mcg/kg/min
SalineDrug
During operation saline infused equal volüme of deksmedetomidine and remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Deksmedetomidine infusion | Active comparator | To prevent agitation deksmedetomidine infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale. Receives: Drug: deksmedetomidine |
| Remifentanil infusion | Experimental | To prevent agitation remifentanil infused during operation at the end of surgery agitation scor measured by Riker sedation agitation scale. Receives: Drug: Remifentanil |
| Saline infusion | Placebo comparator | Saline infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses postoperative agitation score by Riker sedation agitation scale
Measured: Postoperative first hour
Secondary outcomes (1)
Yo asses postoperative side effects emesis, vomitting or pain
Measured: Postoperative first hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Reyhan Polat, MD, Principal investigator, Yildirim Beyazit Education and Research Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104297
- Sponsor's protocol ID
- Agitation
- Acronym
- EA
- Status last verified
- Apr 2014
- First submitted
- 2 Apr 2014
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deksmedetomidin and Remifentanil Infusion on Extubation Agitation and Recovery Conditions on Nasal Septoplasty Operation
- ClinicalTrials.gov ID
- NCT02104297
- Acronym / sponsor ID
- EA / Agitation
- Conditions
- Agitation
- Keywords
- Nasal septum operation, agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 4 Apr 2014 (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.
To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.
Detailed description
Nasal septum operation cause agitation because of nasal package. This research aims determine which agent , deksmedetomidine remifentanil or placebo, is more beneficial to the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deksmedetomidine infusion | Active comparator | Drug: deksmedetomidineTo prevent agitation deksmedetomidine infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale. |
| Remifentanil infusion | Experimental | Drug: RemifentanilTo prevent agitation remifentanil infused during operation at the end of surgery agitation scor measured by Riker sedation agitation scale. |
| Saline infusion | Placebo comparator | Drug: SalineSaline infused during operation and at the end of surgery agitation scor measured by Riker sedation agitation scale. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients
Key exclusion criteria (1 listed)
- patients with any sensitivity each drug
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 |
|---|---|---|
| deksmedetomidineAlso: Precedexdeksmedetomidine infused during operation 0.2 mcg/kg/hour | Drug | Deksmedetomidine infusion |
| RemifentanilAlso: UltivaRemifentanil infused during operation 0.2 mcg/kg/min | Drug | Remifentanil infusion |
| SalineDuring operation saline infused equal volüme of deksmedetomidine and remifentanil | Drug | Saline infusion |
Primary outcome
To asses postoperative agitation score by Riker sedation agitation scale
Time frame: Postoperative first hour
1 secondary outcome
Yo asses postoperative side effects emesis, vomitting or pain
Time frame: Postoperative first hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
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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.
Reyhan Polat, MD principal investigator
Yildirim Beyazit Education and Research Hospita
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 deksmedetomidine, Remifentanil and Saline in people with Agitation, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reyhan Polat, MD (+905326734310, reyhanp9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses postoperative agitation score by Riker sedation agitation scale (time frame: Postoperative first hour). 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 4 Apr 2014.