Intraocular Pressure Changes During Tracheal ExtubationPhase 4NCT02215382
Intraocular Pressure Changes Associated With Tracheal Extubation: Comparison of Sugammadex With Conventional Reversal of Neuromuscular Blockade
A Phase 4 study testing sugammadex and neostigmine+atropine in people with Intraocular Pressure Changes During Tracheal Extubation, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine combination on hemodynamic parameters and intraocular pressure during tracheal extubation. This prospective, randomised study was designed to compare two reversal methods with respect to changes in IOP, heart rate and blood pressure… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intraocular Pressure Changes During Tracheal Extubation
- What is being tested?
- sugammadex and neostigmine+atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2014to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II physical status
- elective surgery
- endotracheal intubation under general anesthesia
Who cannot join
- emergency surgery
- pregnancy
- laparoscopic surgery
- prone position
- BMI > 30 kg/m2
- sedative drug use in last month
- patients with glaucoma.
- ASA > II physical status
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Altinordu, Ordu, 52100
About this study
The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine combination on hemodynamic parameters and intraocular pressure during tracheal extubation.
This prospective, randomised study was designed to compare two reversal methods with respect to changes in IOP, heart rate and blood pressure during tracheal extubation period.
- Being tested
- sugammadex, neostigmine+atropine
- Keywords
- two reversal methods, changes in IOP, heart rate, blood pressure, tracheal extubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
sugammadex 2 mg/kg
neostigmine+atropineDrug
neostigmine 0,05 mg/kg + atropine 0,025 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| sugammadex | Active comparator | Not described Receives: Drug: sugammadex |
| neostigmine + atropine | Active comparator | Not described Receives: Drug: neostigmine+atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
Measured: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
Secondary outcomes (2)
heart rate
Measured: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
blood pressure
Measured: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Pressure Changes During Tracheal ExtubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, özgür yağan, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215382
- Sponsor's protocol ID
- Odu-3
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure Changes Associated With Tracheal Extubation: Comparison of Sugammadex With Conventional Reversal of Neuromuscular Blockade
- ClinicalTrials.gov ID
- NCT02215382
- Acronym / sponsor ID
- Odu-3
- Keywords
- two reversal methods, changes in IOP, heart rate, blood pressure, tracheal extubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine combination on hemodynamic parameters and intraocular pressure during tracheal extubation.
This prospective, randomised study was designed to compare two reversal methods with respect to changes in IOP, heart rate and blood pressure during tracheal extubation period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugammadex | Active comparator | Drug: sugammadex |
| neostigmine + atropine | Active comparator | Drug: neostigmine+atropine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II physical status
- elective surgery
- endotracheal intubation under general anesthesia
Key exclusion criteria (8 listed)
- emergency surgery
- pregnancy
- laparoscopic surgery
- prone position
- BMI > 30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sugammadexsugammadex 2 mg/kg | Drug | sugammadex |
| neostigmine+atropineneostigmine 0,05 mg/kg + atropine 0,025 mg/kg | Drug | neostigmine + atropine |
Primary outcome
intraocular pressure
Time frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
2 secondary outcomes
heart rate
Time frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
blood pressure
Time frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sugammadex and neostigmine+atropine in people with Intraocular Pressure Changes During Tracheal Extubation, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015; AzTrials last refreshed its copy on 7 Nov 2026.