CataractNCT02151305
Different Hemostasis According to the Anesthetic Agents
A study testing Propofol, remifentanil and Sevoflurane in people with Cataract and Retina Detachment, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cataract, Retina Detachment, Pterygium
- What is being tested?
- Propofol, remifentanil and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Apr 2012
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patient scheduled for ophthalmic surgery under general anesthesia
- American Society of Anesthesiologist physical status I or II
Who cannot join
- hematologic disorder
- severe anemia
- liver disease
- kidney disease
- taking a medication interfering with hemostasis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.
We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.
- Conditions
- Cataract, Retina Detachment, Pterygium, Keratitis, Vitreous Hemorrhage
- Being tested
- Propofol, remifentanil, Sevoflurane
- Medical subject headings
- Cataract, Retinal Detachment, Pterygium, Keratitis, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol, remifentanilDrug
SevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia group | Experimental | This group received propofol and remifentanil for the maintenance of general anesthesia. Receives: Drug: Propofol, remifentanil |
| Inhalation anesthesia group | Experimental | This group received sevoflurane for the maintenance of general anesthesia. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clotting time of ROTEM
Measured: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Clot firmness time of ROTEM
Measured: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Alpha angle of ROTEM
Measured: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Maximum clot firmness of ROTEM
Measured: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Secondary outcomes (6)
Hemoglobin
Measured: 10 minutes before the induction of anesthesia
Hematocrit
Measured: 10 minutes before the induction of anesthesia
Platelet count
Measured: 10 minutes before the induction of anesthesia
International normalized ratio of prothrombin time
Measured: 10 minutes before the induction of anesthesia
Activated partial thromboplastin time
Measured: 10 minutes before the induction of anesthesia
Fibrinogen
Measured: 10 minutes before the induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startAug 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyo-Seok Na, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151305
- Sponsor's protocol ID
- ROTEM_anesthesia
- Status last verified
- May 2014
- First submitted
- 27 May 2014
- Last updated
- 30 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Propofol and Sevoflurane on Hemostasis During Ophthalmic Surgery: Rotational Thromboelastographic Study.
- ClinicalTrials.gov ID
- NCT02151305
- Acronym / sponsor ID
- ROTEM_anesthesia
- Conditions
- Cataract, Retina Detachment, Pterygium, Keratitis, Vitreous Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 May 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.
We investigated the hemostatic differences according to the main anesthetic agents by analyzing rotational thromboelastometry (ROTEM) under the hypothesis that propofol-based anesthesia would impair postoperative coagulability more than the sevoflurane-based anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia group | Experimental | Drug: Propofol, remifentanilThis group received propofol and remifentanil for the maintenance of general anesthesia. |
| Inhalation anesthesia group | Experimental | Drug: SevofluraneThis group received sevoflurane for the maintenance of general anesthesia. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patient scheduled for ophthalmic surgery under general anesthesia
- American Society of Anesthesiologist physical status I or II
Key exclusion criteria (5 listed)
- hematologic disorder
- severe anemia
- liver disease
- kidney disease
- taking a medication interfering with hemostasis
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 |
|---|---|---|
| Propofol, remifentanil | Drug | Total intravenous anesthesia group |
| Sevoflurane | Drug | Inhalation anesthesia group |
Primary outcome
Clotting time of ROTEM
Time frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Clot firmness time of ROTEM
Time frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Alpha angle of ROTEM
Time frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
Maximum clot firmness of ROTEM
Time frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia
6 secondary outcomes
Hemoglobin
Time frame: 10 minutes before the induction of anesthesia
Hematocrit
Time frame: 10 minutes before the induction of anesthesia
Platelet count
Time frame: 10 minutes before the induction of anesthesia
International normalized ratio of prothrombin time
Time frame: 10 minutes before the induction of anesthesia
Activated partial thromboplastin time
Time frame: 10 minutes before the induction of anesthesia
Fibrinogen
Time frame: 10 minutes before the induction of anesthesia
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 30 May 2014.
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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.
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 study testing Propofol, remifentanil and Sevoflurane in people with Cataract and Retina Detachment, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 inclusion and 5 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 30 May 2014. 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 South Korea. 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.
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?
Clotting time of ROTEM (time frame: 10 minutes before the induction of anesthesia, 1 h after finishing anesthesia). The study lists 4 primary outcomes in all. 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 30 May 2014.