RhinoplastyNCT04773002
A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA)
An observational study of Rhinoplasty and Ecchymosis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators wanted to investigate the effect of volatile anesthesia and total intravenous anesthesia (TIVA) on ecchymosis, edema, and intraoperative bleeding in rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinoplasty, Ecchymosis, Edema
- What is being tested?
- Different anesthesia methods
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2021to 21 Aug 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Rhinoplasty patients
Who may be able to join
- Between 18 and 65 years
- Planned to rhinoplasty
- An American Society of Anesthesiologists score of 1 or 2
Who cannot join
- Steroid use
- Patients with coagulation disorders, •Rejected to participation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60200
About this study
Official title: A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA) on Ecchymosis, Edema, and Intraoperative Bleeding in Rhinoplasty
In this study, investigators wanted to investigate the effect of volatile anesthesia and total intravenous anesthesia (TIVA) on ecchymosis, edema, and intraoperative bleeding in rhinoplasty.
Read the detailed description
Routine monitorization (blood pressure, pulse, oxygen saturation with pulse oximetry and electrocardiogram) will be applied to all patients taken into the operation room.
In Group P (TIVA), induction of anesthesia will be achieved with 2 mg/kg propofol, 0.6 mg/kg rocuronium, and 1 μ / kg fentanyl. Propofol and remifentanil will be used in the continuation of anesthesia.
In Group S (Volatile), anesthesia will be induced with 2 mg / kg propofol, 0.6 mg / kg rocuronium and 1 μ / kg fentanyl. 50% nitrous oxide + 50% oxygen and 2% sevoflurane will be used in the continuation of anesthesia.
All patients will receive 2 ml/kg/hour Ringer's lactate solution during the operation.
- Conditions
- Rhinoplasty, Ecchymosis, Edema, Hemorrhage
- Being tested
- Different anesthesia methods
- Medical subject headings
- Ecchymosis, Edema, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different anesthesia methodsOther
Total intravenous anesthesia (TIVA)and volatile anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group P | Total intravenous anesthesia (TIVA) Receives: Other: Different anesthesia methods | |
| Group S | Volatile anestesia Receives: Other: Different anesthesia methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema and ecchymosis in rhinoplasty according to the type of anesthesia.
It is evaluation developing edema and ecchymosis according to total intravenous anesthesia and volatile anesthesia in rhinoplasty.
Measured: one time in six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start18 Mar 2021
- Primary completion21 Aug 2021
- Study completion21 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Tapar, Tokat Gaziosmanpasa University
- Investigators
- Muzaffer Katar, Study chair, Gaziosmanpasa university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773002
- Sponsor's protocol ID
- 21-KAEK-006
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA) on Ecchymosis, Edema, and Intraoperative Bleeding in Rhinoplasty
- ClinicalTrials.gov ID
- NCT04773002
- Acronym / sponsor ID
- 21-KAEK-006
- Conditions
- Rhinoplasty, Ecchymosis, Edema, Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 21 Aug 2021 (actual)
- First posted
- 26 Feb 2021 (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.
In this study, investigators wanted to investigate the effect of volatile anesthesia and total intravenous anesthesia (TIVA) on ecchymosis, edema, and intraoperative bleeding in rhinoplasty.
Detailed description
Routine monitorization (blood pressure, pulse, oxygen saturation with pulse oximetry and electrocardiogram) will be applied to all patients taken into the operation room.
In Group P (TIVA), induction of anesthesia will be achieved with 2 mg/kg propofol, 0.6 mg/kg rocuronium, and 1 μ / kg fentanyl. Propofol and remifentanil will be used in the continuation of anesthesia.
In Group S (Volatile), anesthesia will be induced with 2 mg / kg propofol, 0.6 mg / kg rocuronium and 1 μ / kg fentanyl. 50% nitrous oxide + 50% oxygen and 2% sevoflurane will be used in the continuation of anesthesia.
All patients will receive 2 ml/kg/hour Ringer's lactate solution during the operation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | – | Other: Different anesthesia methodsTotal intravenous anesthesia (TIVA) |
| Group S | – | Other: Different anesthesia methodsVolatile anestesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rhinoplasty patients
Key inclusion criteria (3 listed)
- Between 18 and 65 years
- Planned to rhinoplasty
- An American Society of Anesthesiologists score of 1 or 2
Key exclusion criteria (2 listed)
- Steroid use
- Patients with coagulation disorders, •Rejected to participation
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 |
|---|---|---|
| Different anesthesia methodsTotal intravenous anesthesia (TIVA)and volatile anesthesia | Other | Group P, Group S |
Primary outcome
Edema and ecchymosis in rhinoplasty according to the type of anesthesia.
Time frame: one time in six months
It is evaluation developing edema and ecchymosis according to total intravenous anesthesia and volatile anesthesia in rhinoplasty.
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 16 Mar 2022.
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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.
Muzaffer Katar study chair
Gaziosmanpasa university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinoplasty and Ecchymosis, run by Tokat Gaziosmanpasa 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 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: finished, as of the sponsor's last update on 16 Mar 2022. 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?
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?
Edema and ecchymosis in rhinoplasty according to the type of anesthesia. (time frame: one time in six months). 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 16 Mar 2022.