ANZCTR - Registration

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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]

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.

Condition category

Condition code

Anaesthesiology

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]

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At the completion of surgery, anesthesia was withdrawn and the neuromuscular block was reversed using 40–50 micro/kg of neostigmine (intravenous injection) and 15 micro/kg of atropine (intravenous injection).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]

Evaluation of intraocular pressure changes with sugammadex and
neostigmin + atropin with a Tono-Pen XL applanation tonometer.

Timepoint [1]

Intraocular pressure were measured before induction and at 30 sec and 2 and 10 min after extubation.

Secondary outcome [1]

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]

24 hours after completion of the surgery

Secondary outcome [2]

To investigate the effects of sugammadex and neostigmine on complications (gagging, nausea, vomiting, breath holding, laryngospasm, and tremors) after extubation.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Hatay

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Mustafa Kemal University Research Hospital

Address [1]

Department of Anesthesiology and Reanimation
Medical Faculty Mustafa Kemal University Research Hospita, 31120, Serinyol, Antakya, Hatay, Turkey

Country [1]

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]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Institutional Ethics Committee of Mustafa Kemal University

Ethics committee address [1]

Mustafa Kemal University,  Medicine School, 31120, Serinyol, Hatay.

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

09/09/2012

Approval date [1]

04/10/2012

Ethics approval number [1]

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

Dr Sedat Hakimoglu

Address

Department of Anesthesiology and Reanimation, Mustafa Kemal University School of Medicine,31120, Hatay Turkey

Country

Turkey

Phone

+90326229100

Fax

[email protected]

Contact person for public queries

Name

Sedat Hakimoglu

Address

Department of Anesthesiology and Reanimation, Mustafa Kemal University School of Medicine,31120, Hatay Turkey

Country

Turkey

Phone

+90326229100

Fax

[email protected]

Contact person for scientific queries

Name

Sedat Hakimoglu

Address

Department of Anesthesiology and Reanimation, Mustafa Kemal University School of Medicine,31120, Hatay Turkey

Country

Turkey

Phone

+903262291000

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Comparison of sugammadex and neostigmine-atropine on intraocular pressure and postoperative effects.	2016	https://dx.doi.org/10.1016/j.kjms.2016.01.009
Embase	Efficacy and safety of sugammadex versus neostigmine in reversing neuromuscular blockade in adults.	2017	https://dx.doi.org/10.1002/14651858.CD012763

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically