Clinical trial NCT03646500: Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser
Official title: Prospective Randomized Controlled Trial Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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).

Eligibility criteria: 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)

Exclusion Criteria:

* pregnancy
* inability to consent
* under 18 years of age
* not eligible for conscious sedation and/or retrobulbar block.

Primary outcomes:
measure: Leiden Perioperative Care Patient Satisfaction Questionnaire
timeFrame: 1-week
Secondary outcomes:
measure: Core Measures of Outcomes of Anesthesia
timeFrame: 1-week
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University - School of Medicine
name: Delan Jinapriya, MD
role: PRINCIPAL_INVESTIGATOR
References: