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

NCT05661045 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/1
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carbon Monoxide Exposure

Outcome Measures

Primary Outcomes (4)

• Cohb

  carboxyhemoglobin

  t1: first hour of surgery

• tas

  total antioxidant status

  t1: first hour of surgery

• tos

  total oxidant status

  t1: first hour of surgery

• hif-1α

  hypoxia inducible factor 1α

  t1: first hour of surgery

Study Arms (2)

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

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

Interventions

low-flow anesthesia PROCEDURE

Changes in blood carboxyhemoglobin levels as a result of exposure to rebreathing during low-flow anaesthesia.

Group DA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (2)

• Bauer I, Pannen BH. Bench-to-bedside review: Carbon monoxide--from mitochondrial poisoning to therapeutic use. Crit Care. 2009;13(4):220. doi: 10.1186/cc7887. Epub 2009 Aug 14.

  PMID: 19691819 RESULT

• Lee SJ, Ryter SW, Xu JF, Nakahira K, Kim HP, Choi AM, Kim YS. Carbon monoxide activates autophagy via mitochondrial reactive oxygen species formation. Am J Respir Cell Mol Biol. 2011 Oct;45(4):867-73. doi: 10.1165/rcmb.2010-0352OC. Epub 2011 Mar 25.

  PMID: 21441382 RESULT

Study Officials

• VEYSEL KOKSAL, PROF ASS

  same

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anestesiology

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 22, 2022
• Study Start: January 2, 2023
• Primary Completion: June 2, 2024
• Study Completion: June 2, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)