Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000651684
Ethics application status
Approved
Date submitted
6/06/2014
Date registered
20/06/2014
Date last updated
20/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of sugammadex and neostigmine on intraocular pressure
Scientific title
Comparison of sugammadex and neostigmine-atropin on intraocular pressure and postoperative effects in surgical patients.
Secondary ID [1] 284756 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraocular pressure changes were investigated after the general anesthesia in patients who scheduled for arthroscopic surgery in supine position.
The patients have American Society of Anaesthesiologists physical status (ASA) 1-2.
 292124 0
Condition category
Condition code
Anaesthesiology 292457 292457 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sugammadex is the intervention of the study. This drug is the first selective relaxant binding agent. In the study, sugammadex was given as an intravenous injection and each patient received only a single dose . The dosage of Sugammadex is 4mg/kg. Sugammadex was administered at the completion of surgery.
Intervention code [1] 289547 0
Treatment: Drugs
Comparator / control treatment
At the completion of surgery, anesthesia was withdrawn and the neuromuscular block was reversed using 40–50 micro/kg of neostigmine (intravenous injection) and 15 micro/kg of atropine (intravenous injection). The specific dose of neostigmine was determined according to sufficient ventilation and the presence of airway reflexes.
Control group
Active

Outcomes
Primary outcome [1] 292320 0
Evaluation of intraocular pressure changes with sugammadex and
neostigmin + atropin with a Tono-Pen XL applanation tonometer.
Timepoint [1] 292320 0
Intraocular pressure were measured before induction and at 30 sec and 2 and 10 min after extubation.
Secondary outcome [1] 308714 0
To investigate the effects of sugammadex and neostigmine on hemodynamic parameters (heart rate, mean arterial pressure, peripheral arterial oxygen saturation). Heart rate, mean arterial pressure and peripheral arterial oxygen saturation were measured by electrocardiography, non-invasive oscillometric metod and pulse oximetry.
Timepoint [1] 308714 0
24 hours after completion of the surgery
Secondary outcome [2] 308777 0
To investigate the effects of sugammadex and neostigmine on complications (gagging, nausea, vomiting, breath holding, laryngospasm, and tremors) after extubation.
Timepoint [2] 308777 0
24 hours after completion of the surgery

Eligibility
Key inclusion criteria
Patients aged 18–65 years with ASA I–II risk status who underwent arthroscopic surgery under general anesthesia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with chronic diseases other than hypertension, those who had previously undergone ocular surgery, and those with previous ocular diseases were excluded. In addition, patients allergic to tetracaine or other agents used in anesthesia were excluded

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/11/2012
Actual
11/12/2012
Date of last participant enrolment
Anticipated
15/11/2013
Actual
29/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6103 0
Turkey
State/province [1] 6103 0
Hatay

Funding & Sponsors
Funding source category [1] 289371 0
Hospital
Name [1] 289371 0
Mustafa Kemal University Research Hospital
Country [1] 289371 0
Turkey
Primary sponsor type
Individual
Name
Sedat Hakimoglu
Address
Mustafa Kemal University, Faculty of Medicine, Department of Anesthesiology and Reanimation, 31120, Hatay.
Country
Turkey
Secondary sponsor category [1] 288092 0
None
Name [1] 288092 0
none
Address [1] 288092 0
none
Country [1] 288092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291137 0
Institutional Ethics Committee of Mustafa Kemal University
Ethics committee address [1] 291137 0
Mustafa Kemal University, Medicine School, 31120, Serinyol, Hatay.
Ethics committee country [1] 291137 0
Turkey
Date submitted for ethics approval [1] 291137 0
09/09/2012
Approval date [1] 291137 0
04/10/2012
Ethics approval number [1] 291137 0
2012-45

Summary
Brief summary
To investigate the effects of sugammadex and neostigmine on IOP, hemodynamic parameters, and complications after extubation.

Patients aged 18–65 years with a risk status of ASA I–II who underwent arthroscopic surgery under general anesthesia. The patients were randomly assigned into 2 groups. At the end of the surgery, the neuromuscular block was reversed using neostigmine (40–50 microg/kg) and atropine (15 microg/kg) in group 1, and sugammadex (4 mg/kg) in group 2. IOP were measured before induction and at 30 sec and 2 and 10 min after extubation. A Tono-Pen XL applanation tonometer (Medtronic Solan, Jacksonville, FL, USA) was used to measure IOP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49050 0
Dr Sedat Hakimoglu
Address 49050 0
Department of Anesthesiology and Reanimation, Mustafa Kemal University School of Medicine,31120, Hatay Turkey
Country 49050 0
Turkey
Phone 49050 0
+90326229100
Fax 49050 0
Email 49050 0
[email protected]
Contact person for public queries
Name 49051 0
Dr Sedat Hakimoglu
Address 49051 0
Department of Anesthesiology and Reanimation, Mustafa Kemal University School of Medicine,31120, Hatay Turkey
Country 49051 0
Turkey
Phone 49051 0
+90326229100
Fax 49051 0
Email 49051 0
[email protected]
Contact person for scientific queries
Name 49052 0
Dr Sedat Hakimoglu
Address 49052 0
Department of Anesthesiology and Reanimation, Mustafa Kemal University School of Medicine,31120, Hatay Turkey
Country 49052 0
Turkey
Phone 49052 0
+903262291000
Fax 49052 0
Email 49052 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
EmbaseEfficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults.2017https://dx.doi.org/10.1002/14651858.CD012763
EmbaseComparison of sugammadex and neostigmine-atropine on intraocular pressure and postoperative effects.2016https://dx.doi.org/10.1016/j.kjms.2016.01.009
N.B. These documents automatically identified may not have been verified by the study sponsor.