Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia

The investigators are planning to compare the oxygenation values (Pao2/fio2, lactate etc.) in patients who underwent TCI and inhalation anesthesia in rhinoplasty operation.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Functional
• Intervention / Treatment: Procedure: target controlled infusion (TCI) group

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 Type: Observational
• Enrollment (Actual): 106

Contacts and Locations

Study Locations

• Turkey
  • Düzce, Turkey
    • Gizem Demir Şenoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients over the age of 18 who will undergo general anesthesia will be included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: inhalation anesthesia (IA) 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.	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.; Other Names: inhalation anesthesia (IA) group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
airway pressures throughout the operation	Airway pressures in cmH2O will be recorded during both anesthesia methods applied throughout the operation.	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.	during the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	Postoperative nausea, vomiting, recovery time from anesthesia will be recorded.	Postoperative 24 hour
vomiting	Postoperative vomiting, recovery time from anesthesia will be recorded.	Postoperative 24. hour
recovery time	Postoperative recovery time from anesthesia will be recorded.	Postoperative 24 hour

Collaborators and Investigators

• Sponsor: Duzce University
• Investigators: Study Director: yavuz demiraran, Duzce Univercity Anesthesiogly department

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: oxygenation; inhalation anesthesia; target controlled anesthesia
• Other Study ID Numbers: PaO2 /FiO2 ratio for TCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No