Clinical trial NCT05754515: Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia
Official title: Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Functional
Keywords: target controlled anesthesia
oxygenation
inhalation anesthesia
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients over the age of 18 who will undergo general anesthesia will be included in the study.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Have a history of liver or kidney disease
* Coronary artery disease or heart failure
* Anemia
* Hemoglobinopathy
* Sepsis

Primary outcomes:
measure: oxygen concentration change throughout the operation
timeFrame: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8 hours after extubation
measure: tissue oxygen use as lactate change throughout the operation
timeFrame: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8hours after extubation
measure: airway pressures throughout the operation
timeFrame: during the operation
measure: lung compliance throughout the operation
timeFrame: during the operation
Secondary outcomes:
measure: Nausea
timeFrame: Postoperative 24 hour
measure: vomiting
timeFrame: Postoperative 24. hour
measure: recovery time
timeFrame: Postoperative 24 hour
Other outcomes:
Locations:
city: Düzce
country: Turkey
facility: Gizem Demir Şenoğlu
Study officials:
affiliation: Duzce Univercity Anesthesiogly department
name: yavuz demiraran
role: STUDY_DIRECTOR
References: