Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-10-31

Brief Summary

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This is a non-inferiority trial with a prospective randomized controlled design assessing patient satisfaction and complications associated with both retrobulbar block anesthetics (current gold standard) and conscious IV sedation alone (alternative choice of anesthesia) for trans-scleral diode laser (TSD). Patient satisfaction and complications will be measured using standardized patient surveys.

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Detailed Description

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This is a non-inferiority trial with a prospective randomized controlled design assessing patient satisfaction and complications associated with both retrobulbar block anesthetics (current gold standard) and conscious IV sedation alone (alternative choice of anesthesia) for trans-scleral diode laser (TSD). Patient satisfaction and complications will be measured using standardized patient surveys.

Methodology:

1. Patients undergoing TSD would be recruited from one glaucoma subspecialist's practice.
2. Patient consents to TSD at the eye clinic.
3. Clinical trial is mentioned to the patient and if there is interest a consent form is given to the patient to look over and develop questions the patient may want to ask.
4. Pre-anesthesia consult will be conducted to determine eligibility for both conscious sedation and retrobulbar block.
5. Patient is contacted by phone by the study coordinator to discuss whether the patient is still eligible to be a part of the clinical trial and whether the patient is still interested and if yes, what questions the patient might have. If the patient wishes to meet in person this will be arranged and consent can be obtained at that time, but if the patients are from a far distance then the signing of the consent will happen on the day of the procedure (although the discussion would already have taken place over the phone).
6. Patients will be randomized to either conscious sedation group, or retrobulbar injection group (control) via an online program.
7. On the day of the surgery, patients will receive a pre-anesthesia questionnaire (questions include basic identifying, health and surgery information).
8. Patients will receive a post-surgery questionnaire one hour after the surgery, in the recovery room.
9. Patients will receive a phone call for a post-recovery questionnaire 24 hours later.
10. Patients will receive a recovery and complications questionnaire one week later at the clinic (during check-up).

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled non-inferiority trial, with retrobulbar block being the gold standard. Patients will be randomized to receive conscious sedation or retrobulbar injection prior to trans-scleral diode laser (TSD).

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Retrobulbar block

Retrobulbar block administered prior to Transcleral Diode Procedure

Group Type EXPERIMENTAL

Retrobulbar Block

Intervention Type PROCEDURE

Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure

Remifentanil

Conscious IV sedation administered prior to Transcleral Diode Procedure.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type PROCEDURE

Remifentanil administered as intravenous infusion prior to transcleral diode procedure

Interventions

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Retrobulbar Block

Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure

Intervention Type PROCEDURE

Remifentanil

Remifentanil administered as intravenous infusion prior to transcleral diode procedure

Intervention Type PROCEDURE

Other Intervention Names

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remifentanil hydrochloride

Eligibility Criteria

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Inclusion Criteria

* ability to consent
* eligibility for both a conscious sedation and a retrobulbar block (decided through pre-anesthesia consult, which is a standard consult obtained for this procedure)