Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia

NCT ID: NCT05754515

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-06
• Study Completion Date: 2024-06-25

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.

Conditions

Anesthesia; Functional

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

target controlled infusion (TCI) group

Intervention Type: PROCEDURE

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.

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

inhalation anesthesia (IA) group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duzce University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

yavuz demiraran

Role: STUDY_DIRECTOR

Duzce Univercity Anesthesiogly department

Locations

Gizem Demir Şenoğlu

Düzce, Düzce, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PaO2 /FiO2 ratio for TCI

Identifier Type: -

Identifier Source: org_study_id