Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000610538
Ethics application status
Approved
Date submitted
9/01/2024
Date registered
10/05/2024
Date last updated
10/05/2024
Date data sharing statement initially provided
10/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of anesthetic gases on blood values in middle ear surgeries
Scientific title
Investigation of the metabolomic effects of Sevoflurane and Desflurane in middle ear surgery
Secondary ID [1] 311283 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
middle ear surgery 332522 0
Condition category
Condition code
Anaesthesiology 329208 329208 0 0
Anaesthetics
Ear 329771 329771 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our study will include 100 patients scheduled for middle ear surgery (patients who will undergo tympanoplasty or masteidectomy surgery and who have no active infection, body mass index (BMI) <35, aged 18 to 65 years, ASA I-II who agree to participate in the study). Patients will receive standard anesthesia induction (Propofol, rocuronium, fentanyl) and will be endotracheally intubated and connected to the anesthesia device. Patients will be divided into 2 groups. Sevoflurane group will be started with Sevoflurane 1 minimal alveolar concentration (min: 2% - max: 2.5%) as inhalation anesthetic by adjusting the vaporizer. In the desflurane group, The vaporizer will be set and started with desflurane 1 minimal alveolar concentration (min: 6% - max: 9%) as inhalation anesthetic. The first blood sample will be taken from the finger immediately after the inhalation anesthetics are started. Control of inhalation anesthetics used in the groups and vaporizer settings will be done by the anesthesiologist. After the surgical procedure is finished and inhalation anesthesia is stopped, the second blood sample will be taken. Samples will be taken from the fingertips of the patients and absorbed on gutrie paper. Samples will be taken by the anesthesiologist. Total Free amino acid profile will be studied and statistical analysis will be performed. The assignment of patients to groups will be allocated sequentially.
Intervention code [1] 327732 0
Treatment: Drugs
Comparator / control treatment
comparator between Sevoflurane group and Desflurane group as control group
Control group
Active

Outcomes
Primary outcome [1] 337049 0
metabolomic effects of inhalation anesthetics
Timepoint [1] 337049 0
Only Changes in the total free amino acid profile during the period of anesthesia will be studied. Measurements will be taken immediately after the onset of inhalation anesthesia and after the end of the surgical procedure and discontinuation of inhalation anesthesia
Secondary outcome [1] 430471 0
nil
Timepoint [1] 430471 0
nil

Eligibility
Key inclusion criteria
Our study will include 100 patients scheduled for middle ear surgery (patients who will undergo tympanoplasty or masteidectomy surgery and who have no active infection, body mass index (BMI) <35, aged 18 to 65 years, ASA I-II who agree to participate in the study).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People over 65 years of age
2. ASA 3-4 patients
3. People with a body mass index (BMI) >35

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The assignment of patients to groups will be allocated sequentially.
Comparison will be made between Sevoflurane group and Desflurane group
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
Metabo Analyst 5.0
one way anova

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2024
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
100
Accrual to date
62
Final
Recruitment outside Australia
Country [1] 26065 0
Turkey
State/province [1] 26065 0
Sanliurfa

Funding & Sponsors
Funding source category [1] 315538 0
University
Name [1] 315538 0
HARRAN UNIVERSITY - SCIENTIFIC RESEARCH PROJECTS UNIT
Country [1] 315538 0
Turkey
Primary sponsor type
University
Name
HARRAN UNIVERSITY
Address
harran university, osmanbey campus, haliliye, sanliurfa
Country
Turkey
Secondary sponsor category [1] 317622 0
None
Name [1] 317622 0
Address [1] 317622 0
Country [1] 317622 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314437 0
Clinical Research Ethics Committee of Harran University
Ethics committee address [1] 314437 0
Ethics committee country [1] 314437 0
Turkey
Date submitted for ethics approval [1] 314437 0
25/08/2023
Approval date [1] 314437 0
04/09/2023
Ethics approval number [1] 314437 0
2023/16/04

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131582 0
A/Prof Evren Büyükfirat
Address 131582 0
Harran University Faculty of Medicine, Osmanbey Yerleskesi, Sanliurfa-Mardin Karayolu Üzeri 18.Km, 63290 Haliliye/Sanliurfa
Country 131582 0
Turkey
Phone 131582 0
+905065849686
Fax 131582 0
Email 131582 0
[email protected]
Contact person for public queries
Name 131583 0
Evren Büyükfirat
Address 131583 0
Harran University Faculty of Medicine, Osmanbey Yerleskesi, Sanliurfa-Mardin Karayolu Üzeri 18.Km, 63290 Haliliye/Sanliurfa
Country 131583 0
Turkey
Phone 131583 0
+905065849686
Fax 131583 0
Email 131583 0
[email protected]
Contact person for scientific queries
Name 131584 0
Evren Büyükfirat
Address 131584 0
Harran Univesity, Faculty Of Medicine, Department of Anaesthesiology and Reanimation, Osmanbey Yerleskesi, Sanliurfa-Mardin Karayolu Üzeri 18.Km, 63290 Haliliye/Sanliurfa
Country 131584 0
Turkey
Phone 131584 0
+905065849686
Fax 131584 0
Email 131584 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.