AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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

Other trials in Israel

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:

  1. 7%, 5%, 2%, 0.5%
  2. 7%, 2%, 5%, 0.5%
  3. 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.

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 groups in NCT01248689
Study groupRoleWhat they receive
concentration profile 1Active comparatorIOP will be measured under this order of sevoflurane concentrations: 7%, 5%, 2%, 0.5%
Receives: Other: concentration profile 1
concentration profile 2Active comparatorIOP will be measured under this order of sevoflurane concentrations: 7%, 2%, 5%, 0.5%
Receives: Other: concentration profile 2
concentration profile 3Active comparatorIOP 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.

  1. 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.

  1. First posted25 Nov 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionApr 2011 (estimated)
  4. Study completionJun 2011 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in