Emergence AgitationNCT07144007
Prevention of Emergence Agitation in Rhinoplasty With Subanesthetic Propofol and Single-Dose Dexmedetomidine: A Prospective Double-Blind Clinical Study
A study testing Dexmedetomidine and Propofol in people with Emergence Agitation, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
To compare of prevention of emergence agitation in rhinoplasty with subanesthetic propofol and single dose dexmedetomidine Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Dexmedetomidine and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients scheduled for rhinoplasty
- Between 18-65 years
- ASA I-II group
Who cannot join
- Those who are outside the age range of 18-65
- Those who are ASA III and above
- Those with renal,hepatic, cardiac and respiratory diseases
- Those with a known allergy to the medication to be used
- Those who underwent urinary catheterization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Van Yüzüncü Yıl University
Van, Tuşba, 65100
Şükran Sevimli, Assoc. Prof., +90 544 526 29 21, sevimli@hotmail.com
About this study
Official title: Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
To compare of prevention of emergence agitation in rhinoplasty with subanesthetic propofol and single dose dexmedetomidine
Read the detailed description
The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective rhinoplasty, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each. All cases will receive routine preparation for general anesthesia. For anesthesia induction 0,03 mg/kg midazolam, 2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 1 MAC sevoflurane. If intraoperatively needed, an additional dose of 0.5 mcg/kg fentanyl and 0.15 mg/kg rocuronium will be administered. If necessary, nicardipine infusion will be administered to provide controlled hypotension. Before the end of the surgery, 15 mg/kg paracetamol and 1 mg/kg tramadol will be administered for postoperative analgesia. After the nasal tampons are placed, one group will receive 0.5 mg/kg propofol, and the other group will receive 0.5 mcg/kg dexmedetomidine IV infusion over 10 minutes. 4 mg/kg sugammadex will be administered as a muscle relaxant reversal agent. The patient will be extubated when spontaneous breathing occurs and the patient opens their eyes with verbal stimulation. Agitation status will be assessed with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation. Heart rate, systolic, diastolic, mean arterial pressures and saturation values will also be recorded before and after anesthesia induction, at the 5th, 10th, 15th, 20th, 25th, 30th minutes after intubation, at the 1st, 5th, 10th and 15th minutes after extubation. Additionally, if meaningless head and hand-arm movements, laryngospasm, nausea-vomiting, hypoxia (SpO2: <85%) occur at the 1st, 5th, 10th and 15th minutes after extubation, they will be recorded. Also recovery time will be recorded. All data will be recorded and statistical analysis will be made.
- Conditions
- Emergence Agitation
- Being tested
- Dexmedetomidine, Propofol
- Keywords
- emergence agitaion, Propofol, Dexmedetomidine, Rhinoplasty
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing
PropofolDrug
In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine (Group-D) | Active comparator | Group-D: Dexmedetomidine group (n:40). In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing. Receives: Drug: Dexmedetomidine |
| Propofol (Group-P) | Experimental | Group-P: Propofol group (n:40). In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation status
The effect on prevention of emergence agitation of propofol and dexmedetomidine will be evaluated by an anaesthetist with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation
Measured: 1. minute after extubation
Secondary outcomes (3)
Heart rate
Heart rate will be measured pre-induction of anesthesia, post-induction of anesthesia, 5th, 10th, 15th minutes after intubation, during extubation, 1st, 5th, 10th, 15th minutes after extubation
Measured: perioperatively defined times
Blood Pressure
Systolic blood pressure, diastolic blood preesuure, mean arterial pressure will be measured pre-induction of anesthesia, post-induction of anesthesia, 1st, 5th, 10th, 15th minutes after intubation, during extubation, 5th, 10th, 15th minutes after extubation
Measured: perioperatively defined times
oxygen saturation
Oxygen saturation will be measured pre-induction of anesthesia, post-induction of anesthesia, 5th, 10th, 15th minutes after intubation, during extubation, 1st, 5th, 10th, 15th minutes after extubation
Measured: perioperatively defined times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Apr 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergence 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 80 patients scheduled for rhinoplasty will be randomly assigned to two groups. After nasal packing placement, one group will receive intraoperative 0.5 mg/kg propofol, while the other group will receive 10-minute infusion of 0.5 mcg/kg dexmedetomidine.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Emin Keskin, Yuzuncu Yil University
- Investigators
- Şükran Sevimli, Assoc. Prof., Study director, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144007
- Sponsor's protocol ID
- 2025/04-07
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol anda statistical analysis plan will be share with other researchers
Publications
Makkar JK, Bhatia N, Bala I, Dwivedi D, Singh PM. A comparison of single dose dexmedetomidine with propofol for the prevention of emergence delirium after desflurane anaesthesia in children. Anaesthesia. 2016 Jan;71(1):50-7. doi: 10.1111/anae.13230. Epub 2015 Oct 7.
PubMed 26444149
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Van Yuzuncu Yil University Faculty of Medicine Ethics Committee
- ClinicalTrials.gov ID
- NCT07144007
- Acronym / sponsor ID
- 2025/04-07
- Conditions
- Emergence Agitation
- Keywords
- emergence agitaion, Propofol, Dexmedetomidine, Rhinoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- 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 of prevention of emergence agitation in rhinoplasty with subanesthetic propofol and single dose dexmedetomidine
Detailed description
The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 80 patients planned for elective rhinoplasty, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 40 patients each. All cases will receive routine preparation for general anesthesia. For anesthesia induction 0,03 mg/kg midazolam, 2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used. Anesthesia will be maintained with 60% air, 40% oxygen and 1 MAC sevoflurane. If intraoperatively needed, an additional dose of 0.5 mcg/kg fentanyl and 0.15 mg/kg rocuronium will be administered. If necessary, nicardipine infusion will be administered to provide controlled hypotension. Before the end of the surgery, 15 mg/kg paracetamol and 1 mg/kg tramadol will be administered for postoperative analgesia. After the nasal tampons are placed, one group will receive 0.5 mg/kg propofol, and the other group will receive 0.5 mcg/kg dexmedetomidine IV infusion over 10 minutes. 4 mg/kg sugammadex will be administered as a muscle relaxant reversal agent. The patient will be extubated when spontaneous breathing occurs and the patient opens their eyes with verbal stimulation. Agitation status will be assessed with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation. Heart rate, systolic, diastolic, mean arterial pressures and saturation values will also be recorded before and after anesthesia induction, at the 5th, 10th, 15th, 20th, 25th, 30th minutes after intubation, at the 1st, 5th, 10th and 15th minutes after extubation. Additionally, if meaningless head and hand-arm movements, laryngospasm, nausea-vomiting, hypoxia (SpO2: <85%) occur at the 1st, 5th, 10th and 15th minutes after extubation, they will be recorded. Also recovery time will be recorded. All data will be recorded and statistical analysis will be made.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 80 patients scheduled for rhinoplasty will be randomly assigned to two groups. After nasal packing placement, one group will receive intraoperative 0.5 mg/kg propofol, while the other group will receive 10-minute infusion of 0.5 mcg/kg dexmedetomidine.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine (Group-D) | Active comparator | Drug: DexmedetomidineGroup-D: Dexmedetomidine group (n:40). In rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing. |
| Propofol (Group-P) | Experimental | Drug: PropofolGroup-P: Propofol group (n:40). In rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for rhinoplasty
- Between 18-65 years
- ASA I-II group
Key exclusion criteria (5 listed)
- Those who are outside the age range of 18-65
- Those who are ASA III and above
- Those with renal,hepatic, cardiac and respiratory diseases
- Those with a known allergy to the medication to be used
- Those who underwent urinary catheterization
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 |
|---|---|---|
| DexmedetomidineIn rhinoplasty, 10 minute infusion of 0,5 mcg/kg dexmedetomidine will be administered after nasal packing | Drug | Dexmedetomidine (Group-D) |
| PropofolIn rhinoplasty, 0,5 mg/kg propofol IV bolus will be administered after nasal packing | Drug | Propofol (Group-P) |
Primary outcome
Agitation status
Time frame: 1. minute after extubation
The effect on prevention of emergence agitation of propofol and dexmedetomidine will be evaluated by an anaesthetist with the Richmond Agitation Sedation Scale (RASS) at 1 minute after extubation
3 secondary outcomes
Heart rate
Time frame: perioperatively defined times
Blood Pressure
Time frame: perioperatively defined times
oxygen saturation
Time frame: perioperatively defined times
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 26444149Makkar JK, Bhatia N, Bala I, Dwivedi D, Singh PM. A comparison of single dose dexmedetomidine with propofol for the prevention of emergence delirium after desflurane anaesthesia in children. Anaesthesia. 2016 Jan;71(1):50-7. doi: 10.1111/anae.13230. Epub 2015 Oct 7.
- Individual participant dataSharing planned: Yes. Study protocol anda statistical analysis plan will be share with other researchers
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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.
Şükran Sevimli, Assoc. Prof. study director
Yuzuncu Yil University
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 Propofol in people with Emergence Agitation, run by Yuzuncu Yil University 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Emin Keskin, assistant professor (+90 553 071 66 55, emin6559@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation status (time frame: 1. minute after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07144007, which also lists 1 linked publication.
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 27 Aug 2025.