Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001633279
Ethics application status
Approved
Date submitted
22/09/2018
Date registered
3/10/2018
Date last updated
10/01/2019
Date data sharing statement initially provided
10/01/2019
Date results provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Efficacy of Sugammadex Based on Ideal Body Weight of Obstetric Patients with Different Groups of Body Mass Indexes
Scientific title
Evaluation of the Efficacy of Sugammadex Based on Ideal Body Weight of Obstetric Patients with Different Groups of Body Mass Indexes for Reversal of Moderate Rocuronium-Induced Neuromuscular Blockade
Secondary ID [1] 296150 0
Nil known
Universal Trial Number (UTN)
U1111-1220-8234
Trial acronym
SGX (Sugammadex)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 309747 0
pregnancy 309748 0
Condition category
Condition code
Anaesthesiology 308549 308549 0 0
Anaesthetics
Surgery 308550 308550 0 0
Other surgery
Diet and Nutrition 308639 308639 0 0
Obesity
Reproductive Health and Childbirth 308640 308640 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients included in the study will be allocated into three groups according to their BMI. The patients with BMI < 30 kg m-2 (normal BMI) will be allocated in group 1 (n=30), the patients with BMI between 30-40 kg m-2 (obese) in group 2 (n=30) and the patients with BMI > 40 kg m-2 (morbid obese) in group 3 (n=30). In the operating room, a standard monitorization including ECG, non-invasive blood pressure, pulse oxymeter, end-tidal CO2, Bi-spectral index (BIS) and train-of-four (TOF) will be performed to all patients by the anesthesiologist of the operating room. A 20 gauge intravenous line will be placed and each patient will receive 15 mL kg-1 hour-1 isotonic saline infusion. Ideal body weight (IBW) of each patient will be calculated according to the Devine formula (45.5 kg + 2.3 kg/2.4 cm over 152.4 cm) and all of the drugs will be applied based on the calculated IBW of each patient. After preoxygenation with 100% O2 for three minutes, the anesthesiologist will induce general anesthesia with intravenous 1.5-2 mg kg-1 propofol and 0.9 mg kg-1 rocuronium bromide. Endotracheal intubation will be performed when BIS score decreases below 60 and TOF score is below 10%. The anesthesiologist will maintain the anesthesia with 1-2.5% end-tidal sevofluran in a mixture of 40% O2-60% N2O by targeting a bi-spectral index (BIS) value between 40-60. Following delivery of baby by caesarian section, intravenous 4 mg ondansetron and intravenous 1 mcg kg-1 fentanyl will be applied to the mother. The fentanyl dose will be calculated according to the IBW of each patient again and 1 mcg kg-1 fentanyl will be administered. APGAR scores of newborns will be recorded at the first and fifth minute. All patients will receive intravenous 2 mg kg-1 tramadol for postoperative pain management at the end of the surgery. When train-of-four (TOF) value is 25% (moderate neuromuscular blockade), the anesthesiologist will apply intravenous 2 mg kg-1 sugammadex. TOF values will be measured at every 20 seconds intervals after sugammadex dose and if the measured TOF value is under 90% (T4/T1) at the end of 2 minutes, the patients will receive an additional dose of 2 mg kg-1 sugammadex. The time for TOF increased 90% will be recorded and then the patients will be extubated and transferred to Post anesthesia caring unit.
Intervention code [1] 312542 0
Treatment: Drugs
Comparator / control treatment
The patients with normal BMI (control group) will receive the same intervention.
Control group
Active

Outcomes
Primary outcome [1] 307522 0
Total sugammadex dose applied to each patient by directly calculating from data-linkage to medical records
Timepoint [1] 307522 0
At the end of the surgery
Secondary outcome [1] 352195 0
Duration between the first dose of sugammadex and successful extubation as assessed by stopwatch.
Timepoint [1] 352195 0
At the end of the surgery
Secondary outcome [2] 352196 0
Duration between the first dose of sugammadex and motor response to commands as assessed by stopwatch.
Timepoint [2] 352196 0
At the end of the surgery
Secondary outcome [3] 352197 0
Duration between the end of surgery and first breast feeding as assessed by data-linkage to medical records
Timepoint [3] 352197 0
First breast feeding time with a maximum observation period of postoperative first 24 hours.

Eligibility
Key inclusion criteria
The patients over 18 years old with ASA status II and scheduled for an elective caesarean section under general anesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of pulmonary diseases (asthma, chronic obstructive pulmonary disease etc), known allergy to study drugs, use of medications that can affect neuromuscular blockade such as magnesium sulphate, anticonvulsive drugs, macrolids and aminoglycosides, decline participation to the study

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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/efficacy
Statistical methods / analysis
Statistical analysis of the data will be performed by using SPSS 22.0 software version. Beside descriptive statistical methods (mean, median, minimum-maximum, standard deviation, ratio), One-way Anova test will be used for the comparison of parametric variables with normal distribution between three groups and Bonferroni test will be used for comparison between two groups. For comparison of parametric variables with abnormal distribution between three groups, Kruskal Wallis test will be performed and the comparison between two groups will be performed with Mann Whitney U test. Pearson Ki-squre test and Fisher-Freeman-Halton test will be used for the comparison of nonparametric variables. Pearson Correlation Test will be used to assess the relation between body mass index and intraoperative periods or additional sugammadex dose need. A p value < 0.05 will be accepted as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2018
Actual
5/11/2018
Date of last participant enrolment
Anticipated
4/11/2018
Actual
20/12/2018
Date of last data collection
Anticipated
5/11/2018
Actual
21/12/2018
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 20864 0
Turkey
State/province [1] 20864 0
Mugla

Funding & Sponsors
Funding source category [1] 300737 0
Hospital
Name [1] 300737 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 300737 0
Turkey
Primary sponsor type
Individual
Name
Basak ALTIPARMAK
Address
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA
Country
Turkey
Secondary sponsor category [1] 300274 0
None
Name [1] 300274 0
Address [1] 300274 0
Country [1] 300274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301519 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 301519 0
Ethics committee country [1] 301519 0
Turkey
Date submitted for ethics approval [1] 301519 0
04/03/2017
Approval date [1] 301519 0
06/03/2017
Ethics approval number [1] 301519 0
Decision number: VIII

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

Contacts
Principal investigator
Name 87266 0
Dr Basak ALTIPARMAK
Address 87266 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 87266 0
Turkey
Phone 87266 0
+905326726533
Fax 87266 0
Email 87266 0
[email protected]
Contact person for public queries
Name 87267 0
Basak ALTIPARMAK
Address 87267 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 87267 0
Turkey
Phone 87267 0
+905326726533
Fax 87267 0
Email 87267 0
[email protected]
Contact person for scientific queries
Name 87268 0
Basak ALTIPARMAK
Address 87268 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 87268 0
Turkey
Phone 87268 0
+905326726533
Fax 87268 0
Email 87268 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 trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, ending 1 year following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


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
No additional documents have been identified.