The Effect of Blood Carboxyhemoglobin Levels on Total Antioxidant (Tas), Total Oxidant(Tos), Hypoxia Inducible Factor-1a (hif1a) During Low-flow and Normal-flow Anesthesia

June 14, 2024 updated by: Vkoksal, Ataturk Training and Research Hospital
In contrast to toxic CO concentrations, low-dose CO acts as a signaling molecule and can exert many complex cytoprotective effects. Therefore, the effects of low-dose CO are being investigated and developed as a new treatment method for use in various disease processes. However, these studies are mostly in vivo and in vitro studies and clinical studies have not reached a sufficient number. In this study, the effect of subclinical COHB levels on biomarkers such as TAS, TOS, HIF-1α will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

130 patients aged between 18 and 70 with ASA I-II will be included in the study. Patients will be assigned to one of the two study groups in equal numbers using a computerized random numbers table.

In the 1st group (Group DA), the patients will be taken to the operating table. The standard consisting of electrocardiogram (ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored. Prior to induction, the first blood sample (To) will be drawn for COHB and biochemistry analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated orotracheal. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 0.6 L/min (low flow anaesthesia) and fentanyl and rocuronium will be administered intermittently. Patients will be ventilated with a ring system ventilator with a newly changed absorber at a constant tidal volume (body weight kg x 6 mL) and respiratory rate (12/min). At the 1st hour of low flow anesthesia maintenance, a second blood sample (T1) will be taken for COHB and biochemistry analysis. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken from the patients at the postoperative 24th hour in the service for COHB and biochemistry analysis. Blood carboxyhemoglobin (COHB), total antioxidant status (TAS), total oxidant status (TOS), Hypoxia-inducible factor 1α (HIF-1α) values will be calculated.

Patients in group 2 (Group NA) will be taken to the operating table. The standard consisting of electrocardiogram (ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored. Prior to induction, the first blood sample (To) will be drawn for COHB and biochemistry analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated orotracheal. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 2.0 L/min (normal flow anaesthesia) and fentanyl and rocuronium will be administered intermittently. Patients will be ventilated with a ring system ventilator with a newly changed absorber at a constant tidal volume (body weight kg x 6 mL) and respiratory rate (12/min). A second blood sample (T1) will be taken for COHB and biochemistry analysis at the 1st hour of normal flow anesthesia maintenance. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken from the patients at the postoperative 24th hour in the service for COHB and biochemistry analysis. Blood carboxyhemoglobin (COHB), total antioxidant status (TAS), total oxidant status (TOS), Hypoxia-inducible factor 1α (HIF-1α) values will be calculated.

SPSS 25.0 (IBM Corporation, Armonk, New York, United States) program will be used in the statistical analysis of the variables obtained as a result of the study. The conformity of the data to the normal distribution will be evaluated with the Shapiro-Wilk test and the homogeneity of variance with the Levene test. Independent sample t test and Mann Whitney u test will be used to compare two groups with each other according to quantitative data. In order to examine the correlations of the variables with each other, appropriate ones from Pearson Correlation, Kendall's tau-b and Spearman's rho tests will be used considering the distribution of the data. According to the results of the correlation analysis, it will be supported by regression analysis when necessary. Pearson Chi-Square and Fisher Exact tests will be used to compare categorical variables with each other. Quantitative variables will be shown in the tables as mean (standard deviation) and median (Maximum-Minimum), and categorical variables as n(%). Variables will be analyzed at 95% confidence level and p value less than 0.05 will be considered significant.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Atatürk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients aged 18-80, without systemic disease, non-smoker, who will undergo elective surgery under general anesthesia

Description

Inclusion Criteria:

  • 18-70 years old
  • ASA I-II
  • none-smoking
  • without systemic disease
  • elective surgery with general anesthesia

Exclusion Criteria:

  • over 70 years old
  • with cardiovascular disease
  • with respiratory system disease
  • liver or kidney disease
  • pregnant or nursing female patient
  • those who do not want to participate
  • patient with multi-trauma
  • ASA III and above
  • emergency surgery
  • surgery with blood transfusion
  • smokers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group DA
In the Group (DA), the standard consisting of electrocardiogram(ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored.Prior to induction, the first blood sample (To) will be taken for analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated.Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 0.6 L/min and fentanyl,rocuronium will be administered intermittently. Patients will be ventilated with a ventilator at a constant tidal volume (kg x 6 mL) and respiratory rate (12/min). At the 1st hour of low flow anesthesia maintenance, a second blood sample (T1) will be taken for analysis. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken at the postoperative 24th hour in the service for analysis.
Procedure: low-flow anesthesia
Changes in blood carboxyhemoglobin levels as a result of exposure to rebreathing during low-flow anaesthesia.
Group NA
In the Group (NA),the standard consisting of electrocardiogram(ECG), peripheral oxygen saturation (Spo2),non-invasive blood pressure will be monitored.Prior to induction, the first blood sample (To) will be taken for analysis.After induction of anesthesia with propofol and rocuronium, patients will be intubated. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 2.0 L/min and fentanyl, rocuronium will be administered intermittently. Patients will be ventilated with a ventilator at a constant tidal volume (kg x 6 mL) and respiratory rate (12/min). A second blood sample (T1) will be taken for analysis at the 1st hour of normal flow anesthesia maintenance. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken at the postoperative 24th hour in the service for analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohb
Time Frame: t1: first hour of surgery
carboxyhemoglobin
t1: first hour of surgery
tas
Time Frame: t1: first hour of surgery
total antioxidant status
t1: first hour of surgery
tos
Time Frame: t1: first hour of surgery
total oxidant status
t1: first hour of surgery
hif-1α
Time Frame: t1: first hour of surgery
hypoxia inducible factor 1α
t1: first hour of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk Training and Research Hospital

Investigators

  • Principal Investigator: VEYSEL KOKSAL, PROF ASS, same

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

June 2, 2024

Study Completion (Actual)

June 2, 2024

Study Registration Dates

First Submitted

December 3, 2022

First Submitted That Met QC Criteria

December 18, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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