Anesthesia; FunctionalNCT05754515
Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia
An observational study of Anesthesia; Functional, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
The investigators are planning to compare the oxygenation values (Pao2/fio2, lactate etc.) in patients who underwent TCI and inhalation anesthesia in rhinoplasty operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia; Functional
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 25 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients over the age of 18 who will undergo general anesthesia will be included in the study.
Who may be able to join
- Patients older than 18 years and younger than 60 years of age who will be operated under general anesthesia
- Patients in I, II risk groups according to the American Society of Anesthesiologists (ASA) classification
Who cannot join
- ASA III and above patients
- Patients for whom Intensive Care Unit (ICU) indication is prescribed
- Chronic obstructive pulmonary disease
- Having a personal or family history of malignant hyperthermia,
- morbid obesity
- Alcohol or drug addiction
Show all 11Show fewer
- Have a history of liver or kidney disease
- Coronary artery disease or heart failure
- Anemia
- Hemoglobinopathy
- Sepsis
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are planning to compare the oxygenation values (Pao2/fio2, lactate etc.) in patients who underwent TCI and inhalation anesthesia in rhinoplasty operation.
Read the detailed description
Total intravenous anesthesia (TIVA) is a common anesthesia method used today as an alternative to inhalation anesthesia. Loss of consciousness is two important components of general anesthesia, in order to give the patient safe analgesia and not to remember any adverse events related to the operation. While the depth of anesthesia can be controlled by monitoring the minimum alveolar concentration (MAK) in the ventilator devices in the operating room we use modernly, there was no more objective method than measuring the plasma level of drugs in intravenous anesthesia. The schemes created by the anesthetists according to plasma drug levels were used when administering total intravenous anesthesia. Target Controlled Anesthesia (TCI) devices, on the other hand, are pumps that have been used more frequently recently and that can deliver the required blood concentration of a drug in bolus and infusion form according to pharmacokinetics models calculated with personal data. In TCI anesthesia, intravenous infusion of anesthetics provides a more stable drug concentration in the plasma and at the site of action compared to repeated bolus techniques. Thus, it is ensured that the drug remains in the therapeutic range, avoiding the consequences such as over- or under-administration of the drugs. The subject of the study is to determine which of the 2 routinely used methods in rhinoplasty operations affects respiratory functions less.
- Conditions
- Anesthesia; Functional
- Being tested
- target controlled infusion (TCI) group
- Keywords
- target controlled anesthesia, oxygenation, inhalation anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
target controlled infusion (TCI) groupProcedure or surgery
Also called inhalation anesthesia (IA) group
Patients in the TCI group will be anesthetized with propofol and remifentanil throughout the operation.
Patients included in the inhalation anesthesia group will be anesthetized with desflurane and remifentanil with a bispectral index of 40-60 throughout the operation.
| Study group | Role | What they receive |
|---|---|---|
| target controlled infusion (TCI) group | Propofol and remifentanil will be used in TCI anesthesia, and while the patient is under adequate sedation (BIS40-60), muscle relaxation will be provided with 0.6 mg/kg rocurium bromide. While applying TCI anesthesia, the device will use the Minto model for Remifentanil infusion and the Schnider model for Propofol infusion. Receives: Procedure: target controlled infusion (TCI) group | |
| inhalation anesthesia (IA) groups | During anesthesia induction of patients receiving inhalation anesthesia, 60 mg 2% lidocaine, 2 mg/kg propofol, 0.6 mg/kg rocuronium bromide and 1 mcg/kg fentanyl will be used. Desflurane will be used with a minimum alveolar concentration of 1 and for additional intraoperative sedation. remifentanil will be given between 0.05 and 0.2mcg/kg/min according to the patient's needs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen concentration change throughout the operation
In both general anesthesia methods, blood gas measurements will be made at certain intervals, and pao2 /fio2 in percent (%) ratio will be recorded.
Measured: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8 hours after extubation
tissue oxygen use as lactate change throughout the operation
In both general anesthesia methods, blood gas measurements will be made at certain intervals serum lactat values mg/dl ratio will be recorded.
Measured: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8hours after extubation
airway pressures throughout the operation
Airway pressures in cmH2O will be recorded during both anesthesia methods applied throughout the operation.
Measured: during the operation
lung compliance throughout the operation
The lung compliance in in ml/cmH2O will be recorded during both anesthesia methods applied throughout the operation.
Measured: during the operation
Secondary outcomes (3)
Nausea
Postoperative nausea, vomiting, recovery time from anesthesia will be recorded.
Measured: Postoperative 24 hour
vomiting
Postoperative vomiting, recovery time from anesthesia will be recorded.
Measured: Postoperative 24. hour
recovery time
Postoperative recovery time from anesthesia will be recorded.
Measured: Postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start6 Jun 2022
- Primary completion5 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; FunctionalStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yavuz demiraran, Study director, Duzce Univercity Anesthesiogly department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754515
- Sponsor's protocol ID
- PaO2 /FiO2 ratio for TCI
- Status last verified
- Jan 2025
- First submitted
- 24 Oct 2022
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with the personal data protection law numbered 6698 dated 24.03.2016 in the constitution of the Republic of Turkey, personal information must be stored and protected only by the people conducting the study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia
- ClinicalTrials.gov ID
- NCT05754515
- Acronym / sponsor ID
- PaO2 /FiO2 ratio for TCI
- Conditions
- Anesthesia; Functional
- Keywords
- target controlled anesthesia, oxygenation, inhalation anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 3 Mar 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.
The investigators are planning to compare the oxygenation values (Pao2/fio2, lactate etc.) in patients who underwent TCI and inhalation anesthesia in rhinoplasty operation.
Detailed description
Total intravenous anesthesia (TIVA) is a common anesthesia method used today as an alternative to inhalation anesthesia. Loss of consciousness is two important components of general anesthesia, in order to give the patient safe analgesia and not to remember any adverse events related to the operation. While the depth of anesthesia can be controlled by monitoring the minimum alveolar concentration (MAK) in the ventilator devices in the operating room we use modernly, there was no more objective method than measuring the plasma level of drugs in intravenous anesthesia. The schemes created by the anesthetists according to plasma drug levels were used when administering total intravenous anesthesia. Target Controlled Anesthesia (TCI) devices, on the other hand, are pumps that have been used more frequently recently and that can deliver the required blood concentration of a drug in bolus and infusion form according to pharmacokinetics models calculated with personal data. In TCI anesthesia, intravenous infusion of anesthetics provides a more stable drug concentration in the plasma and at the site of action compared to repeated bolus techniques. Thus, it is ensured that the drug remains in the therapeutic range, avoiding the consequences such as over- or under-administration of the drugs. The subject of the study is to determine which of the 2 routinely used methods in rhinoplasty operations affects respiratory functions less.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| target controlled infusion (TCI) group | – | Procedure: target controlled infusion (TCI) groupPropofol and remifentanil will be used in TCI anesthesia, and while the patient is under adequate sedation (BIS40-60), muscle relaxation will be provided with 0.6 mg/kg rocurium bromide. While applying TCI anesthesia, the device will use the Minto model for Remifentanil infusion and the Schnider model for Propofol infusion. |
| inhalation anesthesia (IA) groups | – | –During anesthesia induction of patients receiving inhalation anesthesia, 60 mg 2% lidocaine, 2 mg/kg propofol, 0.6 mg/kg rocuronium bromide and 1 mcg/kg fentanyl will be used. Desflurane will be used with a minimum alveolar concentration of 1 and for additional intraoperative sedation. remifentanil will be given between 0.05 and 0.2mcg/kg/min according to the patient's needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients over the age of 18 who will undergo general anesthesia will be included in the study.
Key inclusion criteria (2 listed)
- Patients older than 18 years and younger than 60 years of age who will be operated under general anesthesia
- Patients in I, II risk groups according to the American Society of Anesthesiologists (ASA) classification
Key exclusion criteria (11 listed)
- ASA III and above patients
- Patients for whom Intensive Care Unit (ICU) indication is prescribed
- Chronic obstructive pulmonary disease
- Having a personal or family history of malignant hyperthermia,
- morbid obesity
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 |
|---|---|---|
| target controlled infusion (TCI) groupAlso: inhalation anesthesia (IA) groupPatients in the TCI group will be anesthetized with propofol and remifentanil throughout the operation. Patients included in the inhalation anesthesia group will be anesthetized with desflurane and remifentanil with a bispectral index of 40-60 throughout the operation. | Procedure or surgery | target controlled infusion (TCI) group |
Primary outcome
oxygen concentration change throughout the operation
Time frame: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8 hours after extubation
In both general anesthesia methods, blood gas measurements will be made at certain intervals, and pao2 /fio2 in percent (%) ratio will be recorded.
tissue oxygen use as lactate change throughout the operation
Time frame: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8hours after extubation
In both general anesthesia methods, blood gas measurements will be made at certain intervals serum lactat values mg/dl ratio will be recorded.
airway pressures throughout the operation
Time frame: during the operation
Airway pressures in cmH2O will be recorded during both anesthesia methods applied throughout the operation.
lung compliance throughout the operation
Time frame: during the operation
The lung compliance in in ml/cmH2O will be recorded during both anesthesia methods applied throughout the operation.
3 secondary outcomes
Nausea
Time frame: Postoperative 24 hour
vomiting
Time frame: Postoperative 24. hour
recovery time
Time frame: Postoperative 24 hour
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 4 Feb 2025.
- Individual participant dataSharing planned: No. In accordance with the personal data protection law numbered 6698 dated 24.03.2016 in the constitution of the Republic of Turkey, personal information must be stored and protected only by the people conducting the study.
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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.
yavuz demiraran study director
Duzce Univercity Anesthesiogly department
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 Anesthesia; Functional, run by Duzce 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 2 inclusion and 11 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 4 Feb 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?
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?
oxygen concentration change throughout the operation (time frame: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8 hours after extubation). The study lists 4 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 Feb 2025.