Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000408886
Ethics application status
Approved
Date submitted
27/12/2019
Date registered
15/04/2021
Date last updated
28/07/2022
Date data sharing statement initially provided
15/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of different fresh gas flow values on myocardial repolarization parameters in patients for rhinoplasty operation
Scientific title
The effect of different fresh gas flow values on myocardial repolarization parameters in patients for rhinoplasty operation
Secondary ID [1] 299980 0
None
Universal Trial Number (UTN)
U1111-1245-8404
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rhinoplasty operation 315444 0
Myocardial repolarization 316247 0
Condition category
Condition code
Anaesthesiology 313743 313743 0 0
Anaesthetics
Cardiovascular 313744 313744 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing rhinoplasty operation will be randomized to receive either low flow anesthesia or normal flow anesthesia groups. Randomisation will be performed with the closed envelope method. Drug interventions will be performed by anaesthetist. Anesthesia induction will be performed with propofol 2mg/kg and fentanyl 1µg/kg. Each group will be given desflurane (50% oxygen and 50% air mixture with 6% desflurane) as an inhaler anesthetic agent. Normal flow anesthesia will be defined as follows: the fresh gas flow was administered at 4-6 L/min for the first 6-8 minutes. After seeing minimum alveolar concentration achieved to +1 on anesthesia device, fresh gas flow rate will be reduced to 2 L/min (fresh gas flow rate: 2 L/min). Low flow anesthesia will be defined as follows: the fresh gas flow was administered at 4-6 L/min for the first 6-8 minutes. After seeing minimum alveolar concentration achieved to +1 on anesthesia device, fresh gas flow rate was reduced to 0.5 L/min (fresh gas flow rate: 0.5 L/min). Desflurane volume will be adjusted according to the MAC 1 in both groups during anesthesia maintenance. The fidelity of of intervention will be assessed by device analytics.
12-lead electrocardiography (ECG) will be taken from all patients during the operation by anaesthetist. In addition, oxygen saturation, heart rate, noninvasive systolic-diastolic blood pressure, total desflurane intake and total consumption, carbon dioxide inspiratory and expiratory concentration, inspiratory and expiratory oxygen values, and oxygen uptake will be monitored during the operation. Hemodynamic data and gas concentration values will be recorded on the monitor preoperatively, after induction, immediately after intubation, at 1, 5, 10 minutes after intubation, and every 5 minutes thereafter and after extubation.
Intervention code [1] 316246 0
Treatment: Drugs
Comparator / control treatment
The comparator is low flow desflurane anesthesia.
Control group
Dose comparison

Outcomes
Primary outcome [1] 322158 0
Myocardial repolarization
Myocardial repolarization will be assessed with QT interval, T peak to end interval and frontal QRS-T angle. These parameters will be assessed from the 12-lead surface electrocardiography (Nihon Kohden, Tokyo, Japan).

QT interval will be measured from the beginning of the QRS complex to the end of T wave.
T peak to end interval will be measured as the interval from the peak of a T wave to the end of T wave.
Frontal QRS-T angle will be measured as the absolute value of the difference between QRS and T wave axes.
Timepoint [1] 322158 0
The following evaluation time points weill be defined for the QT interval, T peak to end interval and frontal QRS-T angle. T1: Pre-operative (basal), T2: immediately after anesthesia induction, T3: immediately after endotrakeal intubation, T4: 5 min. after endotracheal intubation, T5: 15 min. after endotracheal intubation, T6: 30 min. after endotracheal intubation, T7: 60 min. after endotracheal intubation, T8: immediately after extubation, T9: 15 min after extubation
Secondary outcome [1] 377532 0
Mean arterial pressure (MAP).
Patients will monitored and systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with automatic sphygmomanometer. MAP will automatically calculated from SBP and DBP vales by patient monitoring.
Its formula was as follows: [(2 x DBP) + SBP] / 3.
Timepoint [1] 377532 0
The following evaluation time points weill be defined for the MAP. T1: Pre-operative (basal), T2: immediately after anesthesia induction, T3: immediately after endotrakeal intubation, T4: 5 min. after endotracheal intubation, T5: 15 min. after endotracheal intubation, T6: 30 min. after endotracheal intubation, T7: 60 min. after endotracheal intubation, T8: immediately after extubation, T9: 15 min after extubation
Secondary outcome [2] 377533 0
Heart rate (HR).
Patients will be monitored and heart rate will be obtained from this monitoring.
Heart rate will be defined as number of beats per minute.
Timepoint [2] 377533 0
The following evaluation time points weill be defined for the HR. T1: Pre-operative (basal), T2: immediately after anesthesia induction, T3: immediately after endotrakeal intubation, T4: 5 min. after endotracheal intubation, T5: 15 min. after endotracheal intubation, T6: 30 min. after endotracheal intubation, T7: 60 min. after endotracheal intubation, T8: immediately after extubation, T9: 15 min after extubation

Eligibility
Key inclusion criteria
Patients undergoing rhinoplasty operation and aging between 18-65 years, with American Society of Anaesthesiologist (ASA) grades I or II will be included in this randomized study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA grades III or higher; previous history of hepatic, renal or cardiovascular diseases; known allergy to any of the used medications; pregnant patients; patients with electrolyte imbalance;, those using drugs that may affect myocardial repolarization (antiarrhythmic, beta-blocker, positive inotropic agent, tricyclic antidepressant, phenotiazine); bundle branch block on ECG; diabetes mellitus or other endocrine disorder; patients who develop laryngospasm during induction

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
SPSS for Windows 24.0 program will be used for statistical analysis. Continuous variables will be given as mean ± standard deviation or median (25-75 IQR) and categorical variables will be given as percentage. Kolmogorov-Smirnov test will be used to test the normality of data. Comparison of continuous variables will be performed with Student t test or Mann-Whitney-U test according to the normality test. Chi-square test will be used to compare categorical variables. Pearson’s or Sperman correlation coefficient will be used for correlation analysis. Variables found to be p <0.1 in univariate analysis will be included in the multivariate analysis. p <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
30/04/2021
Actual
30/06/2021
Date of last data collection
Anticipated
30/04/2021
Actual
30/06/2021
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 22161 0
Turkey
State/province [1] 22161 0
SANLIURFA

Funding & Sponsors
Funding source category [1] 304438 0
Hospital
Name [1] 304438 0
Sanliurfa Mehmet Akif Inan Training and Research Hospital
Country [1] 304438 0
Turkey
Primary sponsor type
Hospital
Name
Sanliurfa Mehmet Akif Inan Training and Research Hospital
Address
Esentepe, Ertugrul Street. 132 A, 63040 Sanliurfa City Center / Haliliye / Sanliurfa Province
Country
Turkey
Secondary sponsor category [1] 304887 0
None
Name [1] 304887 0
Address [1] 304887 0
Country [1] 304887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304873 0
Harran university clinical research ethics committee
Ethics committee address [1] 304873 0
Ethics committee country [1] 304873 0
Turkey
Date submitted for ethics approval [1] 304873 0
04/10/2019
Approval date [1] 304873 0
14/10/2019
Ethics approval number [1] 304873 0
03/10

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

Contacts
Principal investigator
Name 98486 0
Dr Tugba Bingol Tanriverdi
Address 98486 0
Esentepe, Ertugrul Street. 132 A, 63040 Sanliurfa City Center / Haliliye / Sanliurfa Province
Country 98486 0
Turkey
Phone 98486 0
+905418842232
Fax 98486 0
Email 98486 0
[email protected]
Contact person for public queries
Name 98487 0
MEHMET TERCAN
Address 98487 0
Esentepe, Ertugrul Street. 132 A, 63040 Sanliurfa City Center / Haliliye / Sanliurfa Province
Country 98487 0
Turkey
Phone 98487 0
+905323445635
Fax 98487 0
Email 98487 0
[email protected]
Contact person for scientific queries
Name 98488 0
Zulkif Tanriverdi
Address 98488 0
Harran University, Osmanbey Campus ,Mardin Street, 18A, postal code: 63300, Haliliye/Sanliurfa Province
Country 98488 0
Turkey
Phone 98488 0
+905068823335
Fax 98488 0
Email 98488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the tria will be shared.
When will data be available (start and end dates)?
Beginning 3 months and no end date determined
Available to whom?
anyone who wishes to access it.
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator (e-mail: [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe Effect of Low-Flow and Normal-Flow Desflurane Anesthesia on the Frontal QRS-T Angle in Patients Undergoing Rhinoplasty Operation: A Randomized Prospective Study2022https://doi.org/10.7759/cureus.28920
N.B. These documents automatically identified may not have been verified by the study sponsor.