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Clinical Trials/NCT05754515
NCT05754515
Completed
Not Applicable

Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia

Duzce University1 site in 1 country106 target enrollmentJune 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia; Functional
Sponsor
Duzce University
Enrollment
106
Locations
1
Primary Endpoint
oxygen concentration change throughout the operation
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2022
End Date
June 25, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Duzce University
Responsible Party
Sponsor

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
  • Hemoglobinopathy

Outcomes

Primary Outcomes

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.

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.

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.

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

  • vomiting(Postoperative 24. hour)
  • recovery time(Postoperative 24 hour)
  • Nausea(Postoperative 24 hour)

Study Sites (1)

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