Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia

NCT05754515 | Completed

• 1 other identifier: PaO2 /FiO2 ratio for TCI
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Functional

Keywords

target controlled anesthesia; oxygenation; inhalation anesthesia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Nausea

  Postoperative 24 hour

• vomiting

  Postoperative 24. hour

• recovery time

  Postoperative 24 hour

Study Arms (2)

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

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.

Interventions

target controlled infusion (TCI) group 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.

Also known as: inhalation anesthesia (IA) group

target controlled infusion (TCI) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duzce University: lead

Study Sites (1)

Gizem Demir Şenoğlu

Düzce, Düzce, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Transcobalamins; Population Groups; Anesthesia, Inhalation

Intervention Hierarchy (Ancestors)

Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Carrier Proteins; Globulins; Demography; Population Characteristics; Anesthesia, General; Anesthesia; Anesthesia and Analgesia

Study Officials

• yavuz demiraran

  Duzce Univercity Anesthesiogly department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: March 3, 2023
• Study Start: June 6, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 25, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)