Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000553673
Ethics application status
Approved
Date submitted
16/05/2014
Date registered
23/05/2014
Date last updated
23/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of sugammadex, reversing the effects of rocuronium, on steroid hormone levels
Scientific title
Effect of sugammadex on steroid hormone levels in male patients undergoing elective lower extremity surgery
Secondary ID [1] 284616 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anesthesia for lower extremity surgery 291922 0
neuromuscular blockade 291923 0
steroid hormones 291927 0
Condition category
Condition code
Anaesthesiology 292276 292276 0 0
Anaesthetics
Metabolic and Endocrine 292281 292281 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 50 male patients between 18 and 45 years of age with an ASA (American Anesthesiology Association) class of I or II undergoing elective lower extremity surgery with an expected surgery time of 1 to 3 hours were planned to be in this study. Prior to surgery, patients are going to class into two groups (neostigmin group, Group N; and sugammadex group, Group S). In addition to standard monitoring, train-of-four (TOF) is going to use to monitor the level of neuromuscular blockade. Standard induction (propofol, rocuronium, remifentanyl) and maintenance (seovoflurane, O2) of anesthesia will be performed. At the termination of surgery, neuromuscular blockade will be antagonised using 0.05 mg/kg of neostigmine (intravenous injection) and 0.01 mg/kg of atropin (intravenous injection) in Group N and using 4 mg/kg sugammadex (intravenous injection) in Group S when spontaneous recovery of neuromuscular blockade occurs with the reappearance of T2. A total of three blood samples, just before and 15 minutes and 4 hours after antagonism, will be obtained in each patient to determine serum aldosterone, cortisol, progesterone, and free testosterone levels.
Intervention code [1] 289398 0
Treatment: Drugs
Comparator / control treatment
Group N is a control group. In this group, neostigmine and atropine will be given to the patients during anesthesia recovery.
Control group
Active

Outcomes
Primary outcome [1] 292145 0
serum aldosterone and free testosterone
Timepoint [1] 292145 0
1-just before neostigmine or sugammadex are given to the patient
2- at 15 minutes after neostigmine or sugammadex are given to the patient
3- at 4 hours after neostigmine or sugammadex are given to the patient
Primary outcome [2] 292146 0
serum cortisol level
Timepoint [2] 292146 0
1-just before neostigmine or sugammadex are given to the patient
2- at 15 minutes after neostigmine or sugammadex are given to the patient
3- at 4 hours after neostigmine or sugammadex are given to the patient
Primary outcome [3] 292147 0
serum progesterone level
Timepoint [3] 292147 0
1-just before neostigmine or sugammadex are given to the patient
2- at 15 minutes after neostigmine or sugammadex are given to the patient
3- at 4 hours after neostigmine or sugammadex are given to the patient
Secondary outcome [1] 308293 0
times (minutes) which TOF ratio reachs to 0.7, 0.8 and 0.9 levels.
Timepoint [1] 308293 0
just after neostigmine or sugammadex are given
Secondary outcome [2] 308294 0
heart rate (via ECG)
Timepoint [2] 308294 0
every 5 minutes from induction of anaesthesia until discharge from post-anesthesia care unit.
Secondary outcome [3] 308295 0
presence of postoperative hypotension, cough, nausea, vomiting, dry mouth, and abnormal smell sense

Timepoint [3] 308295 0
just before transfer from the recovery room to the ward surgery
Secondary outcome [4] 308296 0
clinical signs and symptoms of postoperative residual block (to hold above head and leg, and handshake for 5 seconds, and tongue depressor test)
Timepoint [4] 308296 0
just before transfer from the recovery room to the ward surgery
Secondary outcome [5] 308353 0
mean arterial pressure (via noninvasive blood pressure)
Timepoint [5] 308353 0
every 5 minutes from induction of anaesthesia until discharge from post-anesthesia care unit.
Secondary outcome [6] 308354 0
peripheric oxygen saturation (via pulse oximetry)
Timepoint [6] 308354 0
every 5 minutes from induction of anaesthesia until discharge from post-anesthesia care unit.

Eligibility
Key inclusion criteria
Elective lower extremity surgery undergone general anesthesia
ASA I-II
Male patient
18-45 years of age
expected surgery time is 1-3 hours
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
ASA III, IV and V
neuromuscular disease
endocrin disease
psychiatric, liver, kidney, heart diseases, diabetes mellitus and peripheral neuropathic diseases, co-operation difficulties, difficult intubation possibility, steroid or hormone therapy, obesity (body mass index> 30 kg/m2), neuromuscular blockers interact with drug use (such as magnesium)

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)
closed envelope method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using a randomisation table from statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6055 0
Turkey
State/province [1] 6055 0
Elazig

Funding & Sponsors
Funding source category [1] 289246 0
University
Name [1] 289246 0
Firat University Scientific Research Projects Unit
Country [1] 289246 0
Turkey
Primary sponsor type
University
Name
Firat University Scientific Research Projects Unit
Address
Firat University Scientific Research Projects Unit
23119, Elazig
Country
Turkey
Secondary sponsor category [1] 287920 0
None
Name [1] 287920 0
none
Address [1] 287920 0
none
Country [1] 287920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291015 0
Firat University Medical School Ethical Evaluation Commission Chairman
Ethics committee address [1] 291015 0
Firat University Medical School Ethical Evaluation Commission Chairman
Firat University
23119,Elazig
Ethics committee country [1] 291015 0
Turkey
Date submitted for ethics approval [1] 291015 0
14/12/2012
Approval date [1] 291015 0
10/01/2013
Ethics approval number [1] 291015 0

Summary
Brief summary
In this study, the effect of sugammadex, a recently introduced alternative to traditional decurarization by cholinesterase inhibitors, on adrenal cortical hormones has been examined.
After local ethics committee approval were obtained and written informed patient consent will obtain, a total of 50 male patients between 18 and 45 years of age with an ASA (American Anesthesiology Association) class of I or II undergoing elective lower extremity surgery with an expected surgery time of 1 to 3 hours will include in this study. Prior to surgery, patients will categorize into two groups (neostigmin group, Group N; and sugammadex group, Group S). In addition to standard monitorization, train-of-four (TOF ) is going to used to monitorize the level of neuromuscular blockade. Standard induction (propofol, rocuronium, remifentanyl) and maintenance (seovoflurane, O2) of anesthesia will perform. At the termination of surgery, neuromuscular blockade will antagonise using 0.05 mg/kg of neostigmine and 0.01 mg/kg of atropin in Group N and using 4 mg/kg sugammadex in Group S when spontaneous recovery of neuromuscular blockade occurs with the reappearance of T2. A total of three blood samples, just before and 15 minutes and 4 hours after antagonism, will obtain in each patient to determine serum aldosterone, cortisol, progesterone, and free testosterone levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48482 0
A/Prof Ayse Belin OZER
Address 48482 0
Firat University Medical School
Department of Anesthesiology and Reanimation
23119,Elazig
Country 48482 0
Turkey
Phone 48482 0
+90-424-2333555/2069
Fax 48482 0
Email 48482 0
abelinozer@gmail.com
Contact person for public queries
Name 48483 0
Ayse Belin OZER
Address 48483 0
Firat University Medical School
Department of Anesthesiology and Reanimation
23119,Elazig
Country 48483 0
Turkey
Phone 48483 0
+90-424-2333555/2069
Fax 48483 0
Email 48483 0
abelinozer@gmail.com
Contact person for scientific queries
Name 48484 0
Ayse Belin OZER
Address 48484 0
Firat University Medical School
Department of Anesthesiology and Reanimation
23119,Elazig
Country 48484 0
Turkey
Phone 48484 0
+90-424-2333555/2069
Fax 48484 0
Email 48484 0
abelinozer@gmail.com

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

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