NCT03646500

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

Prospective Randomized Controlled Trial Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	Retrobulbar Block	Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure
PROCEDURE	Remifentanil	Remifentanil administered as intravenous infusion prior to transcleral diode procedure

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-08-01
• Completion: 2017-10-01
• First posted: 2018-08-24
• Last updated: 2018-08-28

Locations

1 site across 1 country: Canada