Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001023347
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
14/07/2017
Date last updated
14/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects Of Desflurane And Sevoflurane On Nesfatin1 Levels In
Laparoscopic Cholecystectomy
Scientific title
The Effects Of Desflurane And Sevoflurane On Nesfatin1 Levels In
Laparoscopic Cholecystectomy
Secondary ID [1] 291633 0
None
Universal Trial Number (UTN)
U1111-1195-1365
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholecystectomy patients 302757 0
Condition category
Condition code
Anaesthesiology 302274 302274 0 0
Anaesthetics
Surgery 302412 302412 0 0
Other surgery
Oral and Gastrointestinal 302413 302413 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The groups were randomly and equally identified by drawing group names from an envelope prior to anesthesia induction. Heart rate (HR), mean systolic and diastolic arterial pressures (SAP, DAP, MAP), peripheral O2 saturation (SpO2) of the patients who were taken to the operation were monitorized. A 20-gauge (G) branule was used to enable intravenous access, and 0.9% sodium chloride (5-10 mL/kg/h) was infused. To induce anesthesia, the patients were given 1 mg of lidocaine (Aritmal, 2%, Osel), 1 µg/kg of remifentanil (Ultiva, 5 mg, GlaxoSmithKline), 8 mg/kg of thiopental sodium, and 0.6 mg/kg of rocuronium bromide intravenously. After a three-min preoxygenation with 100% O2 administration through a face mask, orotracheal intubation was performed when sufficient muscle relaxation was observed. Then, patients were ventilated with a Drager anesthesia instrument (Luebeck, Germany), with tidal volume set to 10 mL/kg and frequency set to 12/min. Soda lime (Sorbo-lime, Berkim, Turkey) was used as a CO2 absorbant. For anesthesia maintenance, patients were randomly assigned to two groups. Patients in the first group received inhalation of 6 % desflurane in 60% O2, 40% air (Forane, Abbott Lab., England). Patients in the second group received 2% sevoflurane in 60% O2, 40% air. Patients in both groups received remifentanil infusion (0.25 µg/kg/min) to maintain anesthesia. At the end of the surgery, all patients received 0.5 mg atropine and 1.5 mg neostigmine for decurarization. In all groups, patients received 0.5 mg atropine when heart rate was <40; 10 mg of ephedrine when MAP was <50, and the infusion dose was lowered. Patients received intravenous tramadol (1 mg/kg) and methochloropropamide (10 mg) 30 min before the end of surgery.
Hemodynamic and respiratory parameters (SAP, DAP, MAP, HR, SpO2, etCO2) were recorded before induction, after induction, after entubation, and during extubation. Blood samples were collected before induction (T1), and after extubation when aldrate score was 10 (T2). Blood samples were collected into aprotinin and EDTA-containing tubes. Samples were centrifuged at 3,000 rpm, and plasma samples were aliquoted in polypropylene tubes, and stored at -80 C until further analysis. Five cc of venous blood samples were used to analyze nesfatin-1 levels, by using a commercial ELISA kit according to the vendor’s instructions. (Ray- Biotech, Norcross, GA, USA; catalogue no. EIANES-1).
Intervention code [1] 297705 0
Treatment: Drugs
Comparator / control treatment
We are comparing between DESFLURANE AND SEVOFLURANE groups.
Control group
Active

Outcomes
Primary outcome [1] 301684 0
Nesfatin levels
Timepoint [1] 301684 0
preoperative blood nesfatin levels
intraoperstive blood nesfatin levels 30 mintes after the insufflation
postoperative blood nesfatin levels 30 minutes after the exufflation
Secondary outcome [1] 333557 0
heart rate using ECG
Timepoint [1] 333557 0
before induction, after induction, after entubation, and during extubation.
Secondary outcome [2] 335745 0
arterial blood pressure
Timepoint [2] 335745 0
before induction, after induction, after entubation, and during extubation.
Secondary outcome [3] 335746 0
oxygen saturation using pulse oximetry
Timepoint [3] 335746 0
before induction, after induction, after entubation, and during extubation.

Eligibility
Key inclusion criteria
40-65 years with the American Society Anesthesiology (ASA) Class I-II who were scheduled for laparoscopic cholecystectomy
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA3-4
RENAL FAILURE
HEPATIC FAILURE

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data analysis was performed by using IBM SPSS Statistics version 17.0 software (SPSS Inc., Chicago, IL, USA). Shapiro Wilk test was used to determine whether the distributions of continuous variables were normal or not. While categorical data were shown in number of cases and percentages, descriptive statistics for continuous variables were expressed in mean +/- SD or median (min-max), where applicable. Categorical data were analyzed by the continuity corrected chi-square or Fisher's exact test, where appropriate. The mean differences between the groups were compared by Student’s t test, while the Mann-Whitney U test was used to compare the mean ranks. Wilcoxon sign-rank test was used to assess the statistical significance of the differences between pre- and post-operative nesfatin levels. A p value less than 0.05 was considered statistically significant.
Sample Size Estimation
The primary aim of this study was to compare by means of differences in nesfatin measurements between the groups. A total sample size of 42 (21 in each group) was required to detect at least 30.6-U difference with a power of 80% at 5% significance level. The difference of 30.6 was taken from both pilot study and clinical experience. The sample size estimation was performed by using G*Power 3.0.10 software (Franz Faul, Universitat Kiel, Germany).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2017
Date of last participant enrolment
Anticipated
Actual
1/03/2017
Date of last data collection
Anticipated
Actual
3/04/2017
Sample size
Target
42
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 8781 0
Turkey
State/province [1] 8781 0
ANKARA

Funding & Sponsors
Funding source category [1] 296125 0
Hospital
Name [1] 296125 0
Ataturk Training and Research Hospital
Country [1] 296125 0
Turkey
Funding source category [2] 296126 0
University
Name [2] 296126 0
Yildirim Beyazid University
Country [2] 296126 0
Turkey
Primary sponsor type
Hospital
Name
Ataturk Training and research hospital
Address
Ataturk Training and Research Hospital
Bilkent 06800
Ankara/TURKEY
Country
Turkey
Secondary sponsor category [1] 295022 0
University
Name [1] 295022 0
Yildirim Beyazit University
Address [1] 295022 0
Eskisehir yolu 3. km
Bilkent 06800
ANKARA
Country [1] 295022 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297380 0
Yildirim Beyazid University Clinical Research Ethics Committee
Ethics committee address [1] 297380 0
Ethics committee country [1] 297380 0
Turkey
Date submitted for ethics approval [1] 297380 0
01/12/2016
Approval date [1] 297380 0
01/12/2016
Ethics approval number [1] 297380 0
Number: 26379996/259

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

Contacts
Principal investigator
Name 73858 0
Dr Ayca Tuba Dumanli Ozcan
Address 73858 0
Atatürk Training and Research Hospital
Department of Anesthesiology and Reanimation,
Üniversiteler Mahallesi Bilkent Caddesi No:1 ÇANKAYA / ANKARA
06800
Country 73858 0
Turkey
Phone 73858 0
+905057154125
Fax 73858 0
Email 73858 0
[email protected]
Contact person for public queries
Name 73859 0
Ayca Tuba Dumanli Ozcan
Address 73859 0
Atatürk Training and Research Hospital
Department of Anesthesiology and Reanimation,
Üniversiteler Mahallesi Bilkent Caddesi No:1
ÇANKAYA / ANKARA
06800 Turkey
Country 73859 0
Turkey
Phone 73859 0
+905057154125
Fax 73859 0
Email 73859 0
[email protected]
Contact person for scientific queries
Name 73860 0
Abdulkadir But
Address 73860 0
Atatürk Training and Research Hospital
Department of Anesthesiology and Reanimation,
Üniversiteler Mahallesi Bilkent Caddesi No:1
ÇANKAYA / ANKARA
Turkey 06800
Country 73860 0
Turkey
Phone 73860 0
+90505613424
Fax 73860 0
Email 73860 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseThe effects of Desflurane and Sevoflurane on Nesfatin-1 levels in laparoscopic Cholecystectomy: A randomized controlled trial.2018https://dx.doi.org/10.1186/s12871-018-0484-x
N.B. These documents automatically identified may not have been verified by the study sponsor.