Intraocular PressureNCT01248689
Effect of Sevoflurane Concentration on Intraocular Pressure in Surgical Children With Healthy Eyes
A study testing concentration profile 1, concentration profile 2 and concentration profile 3 in people with Intraocular Pressure, 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- concentration profile 1, concentration profile 2 and concentration profile 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Jun 2011
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children with healthy eyes, undergoing elective surgery for strabismus correction or tear duct probing and irrigation.
Who cannot join
- children with adverse reaction or contraindication (of any other reason) to sevoflurane or remifentanil, and 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
Yifat Klein, PhD, 97236974093, yifat.klein@gmail.com
Nina Gofman, MD
About this study
Official title: The Effect of Different Concentrations of Sevoflorane on Intraocular Pressure in Children Undergoing Ocular Surgery Under General Anesthesia
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. Accurate assessment of IOP is particularly important in infants and children with definite or suspected glaucoma undergoing examination under anesthesia.
Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic agents, such as sevoflurane. Sevoflurane is known to reduce the IOP. During pediatric ocular surgery, the inspired sevoflurane concentration varies continuously and may have an impact over the IOP that could affect the conduct of surgery. In this study the investigators wish to evaluate whether variations in sevoflurane concentration do affect the IOP.
Read the detailed description
Introduction 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. Accurate assessment of IOP is particularly important in infants and children with definite or suspected glaucoma undergoing examination under anesthesia (EUA).
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 [1-3].
Both propofol and sevoflurane are known to reduce the IOP [4-7]. 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 [8], whereas in non-ophthalmic surgery propofol and sevoflurane caused a comparable decrease in IOP [9].
Sevoflurane, an inhalational anesthetic, has a rapid onset of action, faster recovery time and lower incidence of reported side effects in pediatric patients [10], and is also suitable for inhalation induction because it does not irritate the airway [3].
During pediatric ocular surgery, the inspired sevoflurane concentration is normally maximal at induction of anesthesia (approximately end-tidal concentration of 7%), and it is thereafter reduced or discontinued to achieve an end-tidal sevoflurane concentration of <0.1% by the completion of skin closure. In between these time points the inhaled end-tidal concentration gradually decreases and may have an impact over the IOP that could affect the conduct of surgery. 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 [5]. 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. To this end there is no data in the literature to support or disprove this finding.
Study Objective To assess the effect of different end-tidal sevoflurane concentrations on the IOP in children with healthy eyes undergoing extraocular procedures, i.e., strabismus correction and tear duct probing and irrigation.
Study hypothesis We believe that variations in the end-tidal sevoflurane concentrations have no significant effect on the IOP of healthy eyes.
Study design This is a prospective randomized trial of 21 children undergoing ocular surgery. Informed consent will first be obtained from the parent or legal guardian. After induction of anesthesia and before onset of surgery, IOP will be measured in both eyes under four different concentrations of inhaled sevoflurane.
Intra-operative anesthetic management Anesthetic management will be performed by a trained pediatric anesthesiologist. All patients will be premedicated with 0.5 mg/kg (up to 15 mg) midazolam P.O. 30min before surgery. No significant change in IOP has been reported for midazolam [11]. Induction of anesthesia will be carried out with sevoflurane 8% in 100% oxygen carrier gas. After induction of anesthesia, laryngeal mask will be inserted, and sevoflurane end-tidal concentrations will be adjusted according to the study protocol and assigned group (see "patient allocation and assessment"). No other systemic anesthetic agents will be used during IOP measurements. IOP measurements will be performed after induction of anesthesia. Thereafter, maintenance of anesthesia will be carried out with either spontaneous ventilation at one to two minimal alveolar concentration of sevoflurane (2 to 4%) in 100% oxygen, or mechanical ventilation, as commonly used in pediatric surgery. Standardized intraoperative monitoring will be employed for all subjects by an anesthesiologist.
Intra-operative surgical management Routine strabismus correction or tear duct probing and irrigation procedures will be performed on each subject, as described elsewhere [12].
Patient allocation and assessment
Consented patients will be randomly (by means of computer-generated assignment of random numbers) allocated to one of three groups (n=7 in each group). In each group IOP will be measured and recorded under four different predetermined end-tidal sevoflurane concentrations: 7%, 5%, 2%, 0.5%. The order of concentrations will differ between the groups, to eliminate the effect of exposure time:
- 7%, 5%, 2%, 0.5%
- 7%, 2%, 5%, 0.5%
- 7%, 0.5%, 5%, 2% IOP will be measured by the ophthalmologist via both TonoPen XL and Schioz devices. Measurements will be taken from each eye alternatively for three consecutive readings, at each of the abovementioned concentrations. There is no known risk at IOP reading. At the same times, the anesthesiologist will record systolic and diastolic blood pressure (SBP, DBP) and heart rate (HR), End Tidal CO2, via iMDsoft software.
In addition, we will collect demographic data (e.g., age, gender, weight) for each patient. Routine post operative follow up will be performed.
- Conditions
- Intraocular Pressure
- Being tested
- concentration profile 1, concentration profile 2, concentration profile 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentration profile 1Other
Also called IOP measurements 1
IOP will be measured under this order of sevoflurane concentrations:
7%, 5%, 2%, 0.5%
concentration profile 2Other
Also called IOP measurements 2
IOP will be measured under this order of sevoflurane concentrations:
7%, 2%, 5%, 0.5%
concentration profile 3Other
Also called IOP measurements 3
IOP will be measured under this order of sevoflurane concentrations:
7%, 0.5%, 5%, 2%
| Study group | Role | What they receive |
|---|---|---|
| concentration profile 1 | Active comparator | IOP will be measured under this order of sevoflurane concentrations:
7%, 5%, 2%, 0.5% Receives: Other: concentration profile 1 |
| concentration profile 2 | Active comparator | IOP will be measured under this order of sevoflurane concentrations:
7%, 2%, 5%, 0.5% Receives: Other: concentration profile 2 |
| concentration profile 3 | Active comparator | IOP will be measured under this order of sevoflurane concentrations:
7%, 0.5%, 5%, 2% Receives: Other: concentration profile 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
IOP will be measured in both eyes, after induction of anesthesia and before the onset of surgery
Measured: first hour of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startFeb 2011
- Primary completionApr 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraocular PressureStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Idit Matot, MD, Study chair, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248689
- Sponsor's protocol ID
- TASMC-10-IM-0553-CTIL
- Status last verified
- Nov 2010
- First submitted
- 17 Nov 2010
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Artru AA, Momota Y. Trabecular outflow facility and formation rate of aqueous humor during anesthesia with sevoflurane-nitrous oxide or sevoflurane-remifentanil in rabbits. Anesth Analg. 1999 Apr;88(4):781-6. doi: 10.1097/00000539-199904000-00019.
PubMed 10195524
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Concentrations of Sevoflorane on Intraocular Pressure in Children Undergoing Ocular Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT01248689
- Acronym / sponsor ID
- TASMC-10-IM-0553-CTIL
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 25 Nov 2010 (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. Accurate assessment of IOP is particularly important in infants and children with definite or suspected glaucoma undergoing examination under anesthesia.
Anesthetic regimens in this surgical field commonly consist of short-acting anesthetic agents, such as sevoflurane. Sevoflurane is known to reduce the IOP. During pediatric ocular surgery, the inspired sevoflurane concentration varies continuously and may have an impact over the IOP that could affect the conduct of surgery. In this study the investigators wish to evaluate whether variations in sevoflurane concentration do affect the IOP.
Detailed description
Introduction 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. Accurate assessment of IOP is particularly important in infants and children with definite or suspected glaucoma undergoing examination under anesthesia (EUA).
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 [1-3].
Both propofol and sevoflurane are known to reduce the IOP [4-7]. 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 [8], whereas in non-ophthalmic surgery propofol and sevoflurane caused a comparable decrease in IOP [9].
Sevoflurane, an inhalational anesthetic, has a rapid onset of action, faster recovery time and lower incidence of reported side effects in pediatric patients [10], and is also suitable for inhalation induction because it does not irritate the airway [3].
During pediatric ocular surgery, the inspired sevoflurane concentration is normally maximal at induction of anesthesia (approximately end-tidal concentration of 7%), and it is thereafter reduced or discontinued to achieve an end-tidal sevoflurane concentration of <0.1% by the completion of skin closure. In between these time points the inhaled end-tidal concentration gradually decreases and may have an impact over the IOP that could affect the conduct of surgery. 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 [5]. 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. To this end there is no data in the literature to support or disprove this finding.
Study Objective To assess the effect of different end-tidal sevoflurane concentrations on the IOP in children with healthy eyes undergoing extraocular procedures, i.e., strabismus correction and tear duct probing and irrigation.
Study hypothesis We believe that variations in the end-tidal sevoflurane concentrations have no significant effect on the IOP of healthy eyes.
Study design This is a prospective randomized trial of 21 children undergoing ocular surgery. Informed consent will first be obtained from the parent or legal guardian. After induction of anesthesia and before onset of surgery, IOP will be measured in both eyes under four different concentrations of inhaled sevoflurane.
Intra-operative anesthetic management Anesthetic management will be performed by a trained pediatric anesthesiologist. All patients will be premedicated with 0.5 mg/kg (up to 15 mg) midazolam P.O. 30min before surgery. No significant change in IOP has been reported for midazolam [11]. Induction of anesthesia will be carried out with sevoflurane 8% in 100% oxygen carrier gas. After induction of anesthesia, laryngeal mask will be inserted, and sevoflurane end-tidal concentrations will be adjusted according to the study protocol and assigned group (see "patient allocation and assessment"). No other systemic anesthetic agents will be used during IOP measurements. IOP measurements will be performed after induction of anesthesia. Thereafter, maintenance of anesthesia will be carried out with either spontaneous ventilation at one to two minimal alveolar concentration of sevoflurane (2 to 4%) in 100% oxygen, or mechanical ventilation, as commonly used in pediatric surgery. Standardized intraoperative monitoring will be employed for all subjects by an anesthesiologist.
Intra-operative surgical management Routine strabismus correction or tear duct probing and irrigation procedures will be performed on each subject, as described elsewhere [12].
Patient allocation and assessment
Consented patients will be randomly (by means of computer-generated assignment of random numbers) allocated to one of three groups (n=7 in each group). In each group IOP will be measured and recorded under four different predetermined end-tidal sevoflurane concentrations: 7%, 5%, 2%, 0.5%. The order of concentrations will differ between the groups, to eliminate the effect of exposure time:
- 7%, 5%, 2%, 0.5%
- 7%, 2%, 5%, 0.5%
- 7%, 0.5%, 5%, 2% IOP will be measured by the ophthalmologist via both TonoPen XL and Schioz devices. Measurements will be taken from each eye alternatively for three consecutive readings, at each of the abovementioned concentrations. There is no known risk at IOP reading. At the same times, the anesthesiologist will record systolic and diastolic blood pressure (SBP, DBP) and heart rate (HR), End Tidal CO2, via iMDsoft software.
In addition, we will collect demographic data (e.g., age, gender, weight) for each patient. Routine post operative follow up will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| concentration profile 1 | Active comparator | Other: concentration profile 1IOP will be measured under this order of sevoflurane concentrations: 7%, 5%, 2%, 0.5% |
| concentration profile 2 | Active comparator | Other: concentration profile 2IOP will be measured under this order of sevoflurane concentrations: 7%, 2%, 5%, 0.5% |
| concentration profile 3 | Active comparator | Other: concentration profile 3IOP will be measured under this order of sevoflurane concentrations: 7%, 0.5%, 5%, 2% |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children with healthy eyes, undergoing elective surgery for strabismus correction or tear duct probing and irrigation.
Key exclusion criteria (1 listed)
- children with adverse reaction or contraindication (of any other reason) to sevoflurane or remifentanil, and 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 |
|---|---|---|
| concentration profile 1Also: IOP measurements 1IOP will be measured under this order of sevoflurane concentrations: 7%, 5%, 2%, 0.5% | Other | concentration profile 1 |
| concentration profile 2Also: IOP measurements 2IOP will be measured under this order of sevoflurane concentrations: 7%, 2%, 5%, 0.5% | Other | concentration profile 2 |
| concentration profile 3Also: IOP measurements 3IOP will be measured under this order of sevoflurane concentrations: 7%, 0.5%, 5%, 2% | Other | concentration profile 3 |
Primary outcome
IOP
Time frame: first hour of anesthesia
IOP will be measured in both eyes, after induction of anesthesia and before the onset of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2010.
- Background: PubMed 10195524Artru AA, Momota Y. Trabecular outflow facility and formation rate of aqueous humor during anesthesia with sevoflurane-nitrous oxide or sevoflurane-remifentanil in rabbits. Anesth Analg. 1999 Apr;88(4):781-6. doi: 10.1097/00000539-199904000-00019.
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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.
Idit Matot, MD study chair
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing concentration profile 1, concentration profile 2 and concentration profile 3 in people with Intraocular Pressure, 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 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: status not confirmed, as of the sponsor's last update on 25 Nov 2010. 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 Idit Matot, MD (97236974758, iditm@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: first hour of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01248689, which also lists 1 linked publication.
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 25 Nov 2010.