Intraocular PressurePhase 2NCT01273831
Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia
A Phase 2 study testing atracurium and cisatracurium in people with Intraocular Pressure, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which drug makes lower intraocular pressure Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- atracurium and cisatracurium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Jul 2009to Dec 2009
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA class of I or II baseline IOP of lower than 20 mmHg stable hemodynamics no history of ophthalmic diseases not using drugs affecting IOP (e.g. anticholinergics, sympathomimetics) no contraindication for atracurium or cisatracurium administration.
Who cannot join
- difficulty in mask ventilation or in tracheal intubation end expiratory CO2 of below 35 mmHg or over 45 mmHg O2 saturation of below 90%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Effects of Cisatracurium and Atracurium on Intraocular Pressure
The purpose of this study is to determine which drug makes lower intraocular pressure
Read the detailed description
Increase in intraocular pressure (IOP) following tracheal intubation during general anesthesia can be troublesome. The investigators compared the influence of cisatracurium and atracurium on IOP in patients undergoing general anesthesia.
- Conditions
- Intraocular Pressure
- Being tested
- atracurium, cisatracurium
- Keywords
- intraocular pressure, anesthesia,cisatracurium,atracurium.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atracuriumDrug
atracurium, Drop,0.5 mg/kg, one time, one day
cisatracuriumDrug
cisatracurium, drop,0.15mg/kg,one time, one day
| Study group | Role | What they receive |
|---|---|---|
| atracurium | Other | Patients who underwent general anesthesia received atracurium Receives: Drug: atracurium |
| cisatracurium | Other | Patients who underwent general anesthesia received cisatracurium Receives: Drug: cisatracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
determining intraocular pressure in atracurium and cisatracurium groups
Measured: at 2 minutes after intubation
Secondary outcomes (1)
systolic blood pressure
identification of systolic blood pressure in atracurium and cisatracurium groups
Measured: at 2 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Mitra Jabalameri, A.Professor, Study chair, Associate Professor,Anesthesiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273831
- Sponsor's protocol ID
- ASD-1213-10
- Status last verified
- Jul 2009
- First submitted
- 10 Jan 2011
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects of Cisatracurium and Atracurium on Intraocular Pressure
- ClinicalTrials.gov ID
- NCT01273831
- Acronym / sponsor ID
- ASD-1213-10
- Conditions
- Intraocular Pressure
- Keywords
- intraocular pressure, anesthesia,cisatracurium,atracurium.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Jan 2011 (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 purpose of this study is to determine which drug makes lower intraocular pressure
Detailed description
Increase in intraocular pressure (IOP) following tracheal intubation during general anesthesia can be troublesome. The investigators compared the influence of cisatracurium and atracurium on IOP in patients undergoing general anesthesia.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atracurium | Other | Drug: atracuriumPatients who underwent general anesthesia received atracurium |
| cisatracurium | Other | Drug: cisatracuriumPatients who underwent general anesthesia received cisatracurium |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASA class of I or II baseline IOP of lower than 20 mmHg stable hemodynamics no history of ophthalmic diseases not using drugs affecting IOP (e.g. anticholinergics, sympathomimetics) no contraindication for atracurium or cisatracurium administration.
Key exclusion criteria (1 listed)
- difficulty in mask ventilation or in tracheal intubation end expiratory CO2 of below 35 mmHg or over 45 mmHg O2 saturation of below 90%
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 |
|---|---|---|
| atracuriumatracurium, Drop,0.5 mg/kg, one time, one day | Drug | atracurium |
| cisatracuriumcisatracurium, drop,0.15mg/kg,one time, one day | Drug | cisatracurium |
Primary outcome
intraocular pressure
Time frame: at 2 minutes after intubation
determining intraocular pressure in atracurium and cisatracurium groups
1 secondary outcome
systolic blood pressure
Time frame: at 2 minutes after intubation
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 11 Jan 2011.
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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.
Mitra Jabalameri, A.Professor study chair
Associate Professor,Anesthesiology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing atracurium and cisatracurium in people with Intraocular Pressure, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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 11 Jan 2011. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: at 2 minutes after intubation). 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 11 Jan 2011.