AnesthesiaNCT06957470
TCI vs. Manuel TIVA in Septorhinoplasty Surgeries
An observational study of Anesthesia, run by Bulent Ecevit University at 2 sites in Turkey (Türkiye).
Trial summary
Septorhinoplasty is a surgical technique that can be used to correct various nasal deformities.Total intravenous anesthesia (TIVA) is a frequently preferred method as an anesthesia technique in septorhinoplasty surgeries.It has been reported that TIVA reduces the incidence of postoperative nausea and vomiting, is more… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Total Intravenous Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Dec 2026
- Phase
- Observational
- 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
Study population: Patients aged 18-65 years with American Society of Anesthesiology (ASA) physical status I-II who will undergo Septorhinoplasty Surgery under general anesthesia
Who may be able to join
- Patients aged 18-65 years with American Society of Anesthesiology (ASA) physical status I-II who will undergo Septorhinoplasty Surgery under general anesthesia will be included in the study.
Who cannot join
- Patients who do not agree to participate in the study Patients under 18 and over 65 Patients with ASA score III and above Clinical diagnosis of neuropsychiatric disorders Those with a history of chronic NSAID, tranquilizer, opioid or sleeping pill use Clinical diagnosis of Serious cardiac diseases Clinical diagnosis of central-autonomic nervous system disease Clinical diagnosis of Coagulopathy Those with soybean oil allergy and a history of allergy to any study drug BMI >30 kg m2, pregnancy breastfeeding patients
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Zonguladk Bulent ecevit University
Zonguldak, Kozlu, 67600
Bulent Ecevit University
Zonguldak, Zonguldak Province, 67600
About this study
Official title: Comparison of the Effects in Target-controlled and Manually Controlled Total Intravenous Anesthesia on Postoperative Recovery and Patient Quality of Recovery in Septorhinoplasty Surgeries
Septorhinoplasty is a surgical technique that can be used to correct various nasal deformities.Total intravenous anesthesia (TIVA) is a frequently preferred method as an anesthesia technique in septorhinoplasty surgeries.It has been reported that TIVA reduces the incidence of postoperative nausea and vomiting, is more successful in acute postoperative pain control compared to inhalational anesthesia, provides more stable hemodynamics, provides quicker awakening after anesthesia, is more effective in preventing recovery agitation and cough, and is effective in controlled hypotension.
- Conditions
- Anesthesia
- Being tested
- Total Intravenous Anesthesia
- Keywords
- septorhinoplasty, TIVA (total intravenous anesthesia), TCI (target controlled infusion)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Intravenous AnesthesiaProcedure or surgery
It is a general anesthesia technique performed through a combination of intravenous agents administered intravenously by various methods.
| Study group | Role | What they receive |
|---|---|---|
| TCI (target controlled infusion) | Patients in the TCI group will be anesthetized using the infusion method that selects the target area of effect of propofol and remifentanil. Receives: Procedure: Total Intravenous Anesthesia | |
| MCI (manuel controlled infusion) | Patients in the MCI group will be administered propofol and remifentanil as an infusion based on the anesthesiologist's observations. Receives: Procedure: Total Intravenous Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative recovery
Postoperative recovery will evaluate with quality of recovery-40 questionnaire. quality of recovery-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Measured: at postoperative 6 hours and 24 hours
agitation during emergence
Agitation will evaluate with richmond sedation agitation scale. The richmond sedation agitation scale is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation.
Measured: Postoperative 0 and 15. Minutes at the recovery room
Secondary outcomes (3)
surgeon satisfaction
5-point Likert Scale
Measured: at the end of surgery
postoperative pain
Numeric Rating Scale at the PACU
Measured: at the end of the surgery
nausea and vomiting
4-point Likert Scale
Measured: Postoperative 0 hours at recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Apr 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Sena Kuyumcu Hızal, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957470
- Sponsor's protocol ID
- ZBEU-BHIZAL-001
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects in Target-controlled and Manually Controlled Total Intravenous Anesthesia on Postoperative Recovery and Patient Quality of Recovery in Septorhinoplasty Surgeries
- ClinicalTrials.gov ID
- NCT06957470
- Acronym / sponsor ID
- ZBEU-BHIZAL-001
- Conditions
- Anesthesia
- Keywords
- septorhinoplasty, TIVA (total intravenous anesthesia), TCI (target controlled infusion)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 May 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.
Septorhinoplasty is a surgical technique that can be used to correct various nasal deformities.Total intravenous anesthesia (TIVA) is a frequently preferred method as an anesthesia technique in septorhinoplasty surgeries.It has been reported that TIVA reduces the incidence of postoperative nausea and vomiting, is more successful in acute postoperative pain control compared to inhalational anesthesia, provides more stable hemodynamics, provides quicker awakening after anesthesia, is more effective in preventing recovery agitation and cough, and is effective in controlled hypotension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCI (target controlled infusion) | – | Procedure: Total Intravenous AnesthesiaPatients in the TCI group will be anesthetized using the infusion method that selects the target area of effect of propofol and remifentanil. |
| MCI (manuel controlled infusion) | – | Procedure: Total Intravenous AnesthesiaPatients in the MCI group will be administered propofol and remifentanil as an infusion based on the anesthesiologist's observations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 years with American Society of Anesthesiology (ASA) physical status I-II who will undergo Septorhinoplasty Surgery under general anesthesia
Key inclusion criteria (1 listed)
- Patients aged 18-65 years with American Society of Anesthesiology (ASA) physical status I-II who will undergo Septorhinoplasty Surgery under general anesthesia will be included in the study.
Key exclusion criteria (1 listed)
- Patients who do not agree to participate in the study Patients under 18 and over 65 Patients with ASA score III and above Clinical diagnosis of neuropsychiatric disorders Those with a history of chronic NSAID, tranquilizer, opioid or sleeping pill use Clinical diagnosis of Serious cardiac diseases Clinical diagnosis of central-autonomic nervous system disease Clinical diagnosis of Coagulopathy Those with soybean oil allergy and a history of allergy to any study drug BMI >30 kg m2, pregnancy breastfeeding patients
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 |
|---|---|---|
| Total Intravenous AnesthesiaIt is a general anesthesia technique performed through a combination of intravenous agents administered intravenously by various methods. | Procedure or surgery | MCI (manuel controlled infusion), TCI (target controlled infusion) |
Primary outcome
postoperative recovery
Time frame: at postoperative 6 hours and 24 hours
Postoperative recovery will evaluate with quality of recovery-40 questionnaire. quality of recovery-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
agitation during emergence
Time frame: Postoperative 0 and 15. Minutes at the recovery room
Agitation will evaluate with richmond sedation agitation scale. The richmond sedation agitation scale is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation.
3 secondary outcomes
surgeon satisfaction
Time frame: at the end of surgery
postoperative pain
Time frame: at the end of the surgery
nausea and vomiting
Time frame: Postoperative 0 hours at recovery room
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 4 May 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Bulent Ecevit University at 2 sites 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: under way, not looking for participants, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
postoperative recovery (time frame: at postoperative 6 hours and 24 hours). The study lists 2 primary outcomes in all. 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 May 2025.