Rhinoplasty SurgeryEffects of DexNCT06138574
Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study
A study testing Dexmedetomidine and Remifentanil in people with Rhinoplasty Surgery, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital.
Trial summary
Our aim in this treatment was to reveal the effects of remifentanil and dexmetomidine, which we used to provide controlled hypotension in septorhinoplasty surgery, on cardiac electrophysiology. We planned to compare the patients by recording preoperative and postoperative ECGs. Read more about this study
- Who is it for?
- Ages 17 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty Surgery
- What is being tested?
- Dexmedetomidine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Mar 2024
- 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 17 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients with an ASA score of I and between the ages of 17-45 years, who were to undergo general anesthesia with sevofulurane were included in the study.
Who cannot join
- Patients aged <17 and >45 years, patients with liver and/or kidney failure, obese patients (BMI >30), trauma patients, ASA II-III-IV patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study.
- -
About this study
Our aim in this treatment was to reveal the effects of remifentanil and dexmetomidine, which we used to provide controlled hypotension in septorhinoplasty surgery, on cardiac electrophysiology. We planned to compare the patients by recording preoperative and postoperative ECGs. We also planned to record the patients' intraoperative blood pressure, saturation, and pulse rate, rickeragitation scale, and vas score.
- Conditions
- Rhinoplasty Surgery
- Being tested
- Dexmedetomidine, Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
After the induction of general anesthesia, one group (Group: 1) will be administered dexmedotomidin infizyon and group (Group :2)remifentanil
RemifentanilDrug
Remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Effects of Dexmetomidine | Active comparator | Patients in this group will be given dexmedetomidine infusion during the intraoperative period to provide controlled hypotension. Receives: Drug: Dexmedetomidine |
| Effects of Remifentanil | Active comparator | Patients in this group will be given remifentanil infusion during the intraoperative period to provide controlled hypotension. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
iceb
Qt\Qrs
Measured: preoperative and postoperative (immediatly after extubation)
Secondary outcomes (4)
Riker Agitation Scale
7 -Dangerous Agitation, 6 - Very Agitated, 5 - Agitated, 4 - Calm and Cooperative, 3 - sedated, 2- Very Sedated, 1 -Unarousable
Measured: Immediately after extubation
mean arterial pressure
mmHg
Measured: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
heart rate
beats\minute
Measured: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
Numeric Rating Scale
They will be numbered from 1 to 10. 1 mildest 10 most severe pain
Measured: Postoperative 0-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinoplasty SurgeryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138574
- Sponsor's protocol ID
- HTosun
- Acronym
- Effects of Dex
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06138574
- Acronym / sponsor ID
- Effects of Dex / HTosun
- Conditions
- Rhinoplasty Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
Our aim in this treatment was to reveal the effects of remifentanil and dexmetomidine, which we used to provide controlled hypotension in septorhinoplasty surgery, on cardiac electrophysiology. We planned to compare the patients by recording preoperative and postoperative ECGs. We also planned to record the patients' intraoperative blood pressure, saturation, and pulse rate, rickeragitation scale, and vas score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effects of Dexmetomidine | Active comparator | Drug: DexmedetomidinePatients in this group will be given dexmedetomidine infusion during the intraoperative period to provide controlled hypotension. |
| Effects of Remifentanil | Active comparator | Drug: RemifentanilPatients in this group will be given remifentanil infusion during the intraoperative period to provide controlled hypotension. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients with an ASA score of I and between the ages of 17-45 years, who were to undergo general anesthesia with sevofulurane were included in the study.
Key exclusion criteria (2 listed)
- Patients aged <17 and >45 years, patients with liver and/or kidney failure, obese patients (BMI >30), trauma patients, ASA II-III-IV patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study.
- -
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 |
|---|---|---|
| DexmedetomidineAfter the induction of general anesthesia, one group (Group: 1) will be administered dexmedotomidin infizyon and group (Group :2)remifentanil | Drug | Effects of Dexmetomidine |
| RemifentanilRemifentanil | Drug | Effects of Remifentanil |
Primary outcome
iceb
Time frame: preoperative and postoperative (immediatly after extubation)
Qt\Qrs
4 secondary outcomes
Riker Agitation Scale
Time frame: Immediately after extubation
mean arterial pressure
Time frame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
heart rate
Time frame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
Numeric Rating Scale
Time frame: Postoperative 0-2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Remifentanil in people with Rhinoplasty Surgery, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital.
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 2 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
iceb (time frame: preoperative and postoperative (immediatly after extubation)). 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 18 Nov 2023.