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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646500
• Other study ID #: 18096
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Retrobulbar Block
Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure
• Remifentanil
Remifentanil administered as intravenous infusion prior to transcleral diode procedure

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leiden Perioperative Care Patient Satisfaction Questionnaire	Self reported questionnaire measures patient satisfaction with perioperative care in the following dimensions: Information, Discomfort and Needs, Fear and Concern, Staff-Patient relationship, Service. Information, Staff-Patient Relationship scored as on a 5 point scale: Completely Satisfied, Dissatisfied, Not satisfied, nor dissatisfied, Satisfied, Completely Satisfied. Discomfort and needs and Fear and Concern are scored on a 5 point scale: Not at all, A little bit, Moderately, Quite a bit, Extremely).	1-week
Secondary	Core Measures of Outcomes of Anesthesia	Complication Rates	1-week