Study on the Impact of Ocular Anesthetic Procedures in Ocular Blood Flow

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01840215
Collaborator
(none)
240
1
21.9
10.9

Study Details

Study Description

Brief Summary

Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the past decades. When deciding for a retrobulbar block, the local injection of varying mixtures and volumes of fast-acting anesthetics (such as lidocaine) - with or without a vasoconstrictive agent (such as adrenaline) - coupled with Hyaluronidase have been the standard care to provide painless surgery while minimizing the possible risks such as increased intraocular pressure (IOP), brainstem anesthesia, toxic reaction and ocular blood flow changes. These iatrogenic-induced vascular dysfunctions have been also suggested to play a role in intra-operatory vision loss (a "wipe-out" phenomenon) in patients with advanced glaucoma.

The rationale for the use of epinephrine in retrobulbar anesthesia is to slow absorption of the anesthetic in general circulation and thus to achieve a longer effect in the orbit. However, studies on ocular blood flow after adrenaline-containing compounds have consistently showed a decrease in ocular blood flow, thus raising the issue of whether it should be used in patients with known vascular dysfunction, namely glaucoma patients. Nevertheless, there has been no study to verify this claim concerning the safety of non-adrenaline containing anesthetics.

Injecting a pre-determined volume of anesthetic compound behind the globe, regardless of its formulation has also been debated. The orbital pressure increase can lead to a number of adverse reactions, not only increasing IOP but also potentially decreasing vascular input by local compression. In glaucoma for instance, there has been suggested optic nerve sheaths to be less elastic than in healthy individuals, potentially making this structure less compliant to outside compression. These more rigid orbital tissues could also impair the orbit's ability to deal with the iatrogenic increased volume.

As seen, the current concepts on the impact of ocular anesthesiology in the orbit and the vascular supply to the eye are limited to a small number of non-homogeneous studies. We aim to study this impact through a non-invasive, widely established ultrasound based method of ocular blood flow research (color Doppler Imaging). Potentially, our study could help determine a taylor-made choice of the anesthesiology procedure to apply to a specific patient, thereby advancing the current standard of care in ophthalmology.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Ultrasound B-mode scans will be performed before and after the anesthetic procedure

    2. Doppler scan will be added to the B-mode ultrasound to register the blood flow pattern of the ophthalmic and central retinal arteries

    3. Blood pressure and heart rate will be monitored

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    240 participants
    Time Perspective:
    Prospective
    Official Title:
    Impact of Topical, Retrobulbar and General Anesthesia in Ocular Blood Flow
    Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Controls

    Patients scheduled for elective ophthalmic surgery with no family history of glaucoma, an increased or asymmetrical cup/disc ratio or any other optic disc structural change (notching, disc hemorrhage) or an intraocular pressure (IOP) above 21 mmHg that could suggest possible glaucoma suspects.

    Primary open-angle Glaucoma

    Patients scheduled for an elective glaucoma surgery that present with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at least one measurement of IOP of >21 mmHg required

    Normal Tension Glaucoma

    Patients scheduled for an elective glaucoma surgery that present with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at maximum recorded IOP of < 21 mmHg.

    Outcome Measures

    Primary Outcome Measures

    1. Ocular blood flow change [Participants will be followed for the duration of hospital stay, an expected average of 2 hours]

      The investigators will test whether anesthetic procedures in ophthalmic surgery (topical, retrobulbar and general anesthesia) induce a change in retrobulbar blood flow. The difference in ocular blood flow velocities between pre and post anesthetic induction will be performed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • individuals over 18 years old

    • willing to sign an informed consent and able to comply with the requirements of the study

    Exclusion Criteria:
    • history of ocular trauma

    • previous extraocular surgery

    • ocular disease other than the one motivating surgery

    • systemic diseases with ocular involvement like diabetes or Graves Ophthalmopathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KU Leuven Leuven Vlaams-Brabant Belgium 3000 Leuven

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Ingeborg Stalmans, MD, PhD, UZ Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01840215
    Other Study ID Numbers:
    • S16022013
    First Posted:
    Apr 25, 2013
    Last Update Posted:
    May 29, 2015
    Last Verified:
    Feb 1, 2013
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 29, 2015