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Completed

NCT Number: NCT05754515

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gizem Demir Şenoğlu

Düzce, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: inhalation anesthesia (IA) group

Primary outcomes

  1. oxygen concentration change throughout the operation

    Time frame: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8 hours after extubation

    In both general anesthesia methods, blood gas measurements will be made at certain intervals, and pao2 /fio2 in percent (%) ratio will be recorded.

  2. tissue oxygen use as lactate change throughout the operation

    Time frame: 6 periods; 0. basal blood gas(preoperation), 5 min after intubation, 2 hours after intubation, 5 minutes before extubation, 8hours after extubation

    In both general anesthesia methods, blood gas measurements will be made at certain intervals serum lactat values mg/dl ratio will be recorded.

  3. airway pressures throughout the operation

    Time frame: during the operation

    Airway pressures in cmH2O will be recorded during both anesthesia methods applied throughout the operation.

  4. lung compliance throughout the operation

    Time frame: during the operation

    The lung compliance in in ml/cmH2O will be recorded during both anesthesia methods applied throughout the operation.

Secondary outcomes

  1. Nausea

    Time frame: Postoperative 24 hour

    Postoperative nausea, vomiting, recovery time from anesthesia will be recorded.

  2. vomiting

    Time frame: Postoperative 24. hour

    Postoperative vomiting, recovery time from anesthesia will be recorded.

  3. recovery time

    Time frame: Postoperative 24 hour

    Postoperative recovery time from anesthesia will be recorded.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2023
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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