Comparing Conscious Sedation to Retrobulbar Block Anesthetics During

Status Completed

Clinical Trial Summary

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Glaucoma

Clinical Trial Details

NCT number	NCT03646500
Study type	Interventional
Source	Queen's University
Contact
Status	Completed
Phase	N/A
Start date	July 2015
Completion date	October 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms