IOP Changes Due to Anesthesia (Healthy Patients)NCT01575626
The Effect of Different Sevoflurane Concentrations on Intraocular Pressure in Patients Undergoing Ocular Surgery Under General Anesthesia
A study testing Sevoflurane in people with IOP Changes Due to Anesthesia (Healthy Patients), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
One important goal in anesthetic management during ocular surgery is to provide adequate control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients with glaucoma or a penetrating open-eye injury. There is an ongoing debate over the effect of anesthetic agents on the IOP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IOP Changes Due to Anesthesia (Healthy Patients)
- What is being tested?
- Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to May 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study will include both men and women over 18 years old undergoing elective surgery for strabismus correction or tear duct probing and irrigation under general anesthesia.
Who cannot join
- Patients with known allergies,
- adverse reaction or contraindication (of any other reason) to sevoflurane or remifentanil, or any other anesthetic drug,
- patients with pre-existing intra-ocular ophthalmic disease, or infection.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
Nina Gofman, MD, 972-527360475, ninagof@gmail.com
About this study
One important goal in anesthetic management during ocular surgery is to provide adequate control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients with glaucoma or a penetrating open-eye injury. There is an ongoing debate over the effect of anesthetic agents on the IOP. Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic agents, such as propofol and sevoflurane, usually combined with short-acting analgesics, such as remifentanil. Both propofol and sevoflurane are known to reduce the IOP. To this end there is no data in the literature to support or disprove this finding.
Study Hypothesis Variations in the end-tidal sevoflurane concentrations have no significant effect on the IOP.
Read the detailed description
One important goal in anesthetic management during ocular surgery is to provide adequate control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients with glaucoma or a penetrating open-eye injury. There is an ongoing debate over the effect of anesthetic agents on the IOP. Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic agents, such as propofol and sevoflurane, usually combined with short-acting analgesics, such as remifentanil. Both propofol and sevoflurane are known to reduce the IOP. Previous studies have compared these two anesthetics protocols in order to determine which provides superior control of the IOP. Propofol produced significantly lower IOP measurements compared to sevoflurane (both combined with remifentanil), in cataract surgery, whereas in non-ophthalmic surgery propofol and sevoflurane caused a comparable decrease in IOP. Sevoflurane, an inhalational anesthetic, has a rapid onset of action faster recovery time and is also suitable for inhalation induction because it does not irritate the airway. A prospective randomized clinical trial compared the effects of ketamine and sevoflurane on IOP during the eight minutes after induction of anesthesia (in 2-minute intervals) in children with suspected or diagnosed glaucoma undergoing EUA. During these 8 minutes the IOP decreased significantly only in the sevoflurane group. This finding contradicted claims that measurements immediately after induction are relatively unaffected by anesthetics and suggested that variations in sevoflurane concentration do affect the IOP. Yoshitake et al showed that the remarkable reductions of IOP after inductions are probably caused by induction agents, suggesting that sevoflurane is a useful anesthetic for elderly patients receiving ophthalmic surgeries. To this end there is no data in the literature to support or disprove this finding.
Study Hypothesis Variations in the end-tidal sevoflurane concentrations have no significant effect on the IOP.
- Being tested
- Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
All active comparators of this study have the same intervention as mentioned ahead:
First IOP measurement will be performed just before anesthesia induction. Standard general anesthesia will be induced using propofol (5 mcg/ml) administered by target controlled infusion (TCI - Schnider model),fentanyl and rocuronium according to standard protocol of general anesthesia. The second IOP measurement will be performed just before tracheal intubation.
Following tracheal intubation, concentration of propofol will be decreased till 0 and anesthesia with sevoflurane will be started, followed by 3 more IOP measurements for different end-tidal sevoflurane concentrations (Consented patients will be randomly allocated to one of three groups as mentioned).
Total of 5 IOP measurements. IOP will be measured by the ophthalmologist via both TonoPen XL and Schioz devices.
| Study group | Role | What they receive |
|---|---|---|
| first sevoflurane concentration | Active comparator | patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 0%, 7%, 4% Receives: Drug: Sevoflurane |
| second sevoflurane concentration | Active comparator | patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 4%, 7%, 0% Receives: Drug: Sevoflurane |
| third sevoflurane concentration | Active comparator | patients will be given 3 different end-tidal sevoflurane concentrations in the following order: 7%, 4%, 0% Receives: Drug: Sevoflurane |
| Propofol | Active comparator | General anesthesia will be induced using propofol (5 mcg/ml) administered by target controlled infusion (TCI - Schnider model).Following tracheal intubation, concentration of propofol will be decreased till 0. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of different end-tidal sevoflurane concentrations on the IOP
To assess the effect of different end-tidal sevoflurane concentrations on the IOP in patients undergoing extraocular procedures, i.e. strabismus correction and tear duct probing and irrigation under general anesthesia.
Measured: 1 year
Secondary outcomes (1)
propofol vs. sevoflurane on IOP
To compare the influence of propofol vs. sevoflurane on IOP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IOP Changes Due to Anesthesia (Healthy Patients)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575626
- Sponsor's protocol ID
- TASMC-12-IM-0011-CTIL
- Status last verified
- Apr 2012
- First submitted
- 28 Mar 2012
- Last updated
- 11 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Sevoflurane Concentrations on Intraocular Pressure in Patients Undergoing Ocular Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01575626
- Acronym / sponsor ID
- TASMC-12-IM-0011-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2012
- Primary completion
- May 2013 (estimated)
- First posted
- 11 Apr 2012 (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.
One important goal in anesthetic management during ocular surgery is to provide adequate control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients with glaucoma or a penetrating open-eye injury. There is an ongoing debate over the effect of anesthetic agents on the IOP. Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic agents, such as propofol and sevoflurane, usually combined with short-acting analgesics, such as remifentanil. Both propofol and sevoflurane are known to reduce the IOP. To this end there is no data in the literature to support or disprove this finding.
Study Hypothesis Variations in the end-tidal sevoflurane concentrations have no significant effect on the IOP.
Detailed description
One important goal in anesthetic management during ocular surgery is to provide adequate control of intraocular pressure (IOP). An increase in IOP may be catastrophic in patients with glaucoma or a penetrating open-eye injury. There is an ongoing debate over the effect of anesthetic agents on the IOP. Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic agents, such as propofol and sevoflurane, usually combined with short-acting analgesics, such as remifentanil. Both propofol and sevoflurane are known to reduce the IOP. Previous studies have compared these two anesthetics protocols in order to determine which provides superior control of the IOP. Propofol produced significantly lower IOP measurements compared to sevoflurane (both combined with remifentanil), in cataract surgery, whereas in non-ophthalmic surgery propofol and sevoflurane caused a comparable decrease in IOP. Sevoflurane, an inhalational anesthetic, has a rapid onset of action faster recovery time and is also suitable for inhalation induction because it does not irritate the airway. A prospective randomized clinical trial compared the effects of ketamine and sevoflurane on IOP during the eight minutes after induction of anesthesia (in 2-minute intervals) in children with suspected or diagnosed glaucoma undergoing EUA. During these 8 minutes the IOP decreased significantly only in the sevoflurane group. This finding contradicted claims that measurements immediately after induction are relatively unaffected by anesthetics and suggested that variations in sevoflurane concentration do affect the IOP. Yoshitake et al showed that the remarkable reductions of IOP after inductions are probably caused by induction agents, suggesting that sevoflurane is a useful anesthetic for elderly patients receiving ophthalmic surgeries. To this end there is no data in the literature to support or disprove this finding.
Study Hypothesis Variations in the end-tidal sevoflurane concentrations have no significant effect on the IOP.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| first sevoflurane concentration | Active comparator | Drug: Sevofluranepatients will be given 3 different end-tidal sevoflurane concentrations in the following order: 0%, 7%, 4% |
| second sevoflurane concentration | Active comparator | Drug: Sevofluranepatients will be given 3 different end-tidal sevoflurane concentrations in the following order: 4%, 7%, 0% |
| third sevoflurane concentration | Active comparator | Drug: Sevofluranepatients will be given 3 different end-tidal sevoflurane concentrations in the following order: 7%, 4%, 0% |
| Propofol | Active comparator | Drug: SevofluraneGeneral anesthesia will be induced using propofol (5 mcg/ml) administered by target controlled infusion (TCI - Schnider model).Following tracheal intubation, concentration of propofol will be decreased till 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study will include both men and women over 18 years old undergoing elective surgery for strabismus correction or tear duct probing and irrigation under general anesthesia.
Key exclusion criteria (3 listed)
- Patients with known allergies,
- adverse reaction or contraindication (of any other reason) to sevoflurane or remifentanil, or any other anesthetic drug,
- patients with pre-existing intra-ocular ophthalmic disease, or infection.
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 |
|---|---|---|
| SevofluraneAll active comparators of this study have the same intervention as mentioned ahead: First IOP measurement will be performed just before anesthesia induction. Standard general anesthesia will be induced using propofol (5 mcg/ml) administered by target controlled infusion (TCI - Schnider model),fentanyl and rocuronium according to standard protocol of general anesthesia. The second IOP measurement will be performed just before tracheal intubation. Following tracheal intubation, concentration of propofol will be decreased till 0 and anesthesia with sevoflurane will be started, followed by 3 more IOP measurements for different end-tidal sevoflurane concentrations (Consented patients will be randomly allocated to one of three groups as mentioned). Total of 5 IOP measurements. IOP will be measured by the ophthalmologist via both TonoPen XL and Schioz devices. | Drug | Propofol, first sevoflurane concentration, second sevoflurane concentration, third sevoflurane concentration |
Primary outcome
effect of different end-tidal sevoflurane concentrations on the IOP
Time frame: 1 year
To assess the effect of different end-tidal sevoflurane concentrations on the IOP in patients undergoing extraocular procedures, i.e. strabismus correction and tear duct probing and irrigation under general anesthesia.
1 secondary outcome
propofol vs. sevoflurane on IOP
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2012.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane in people with IOP Changes Due to Anesthesia (Healthy Patients), run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Apr 2012. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nina Gofman, MD (972-527360475, ninagof@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of different end-tidal sevoflurane concentrations on the IOP (time frame: 1 year). 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 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.