Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia

Anesthesia; Functional Clinical Trial

Official title:

Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754515
• Other study ID #: PaO2 /FiO2 ratio for TCI
• Status: Recruiting
• Start date: June 6, 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Duzce University
• Contact: gizem demir senoglu
• Phone: +905059313588
• Email: gizem123demir[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia; Functional

Intervention

Procedure:
• target controlled infusion (TCI) 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.

Locations

Country	Name	City	State
Turkey	Gizem Demir Senoglu	Düzce

Sponsors (1)

Lead Sponsor	Collaborator
Duzce University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8 hours after extubation
Primary	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.	6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8hours after extubation
Primary	airway pressures throughout the operation	Airway pressures in cmH2O will be recorded during both anesthesia methods applied throughout the operation.	during the operation
Primary	lung compliance throughout the operation	The lung compliance in in ml/cmH2O will be recorded during both anesthesia methods applied throughout the operation.	during the operation
Secondary	Nausea	Postoperative nausea, vomiting, recovery time from anesthesia will be recorded.	Postoperative 24 hour
Secondary	vomiting	Postoperative vomiting, recovery time from anesthesia will be recorded.	Postoperative 24. hour
Secondary	recovery time	Postoperative recovery time from anesthesia will be recorded.	Postoperative 24 hour