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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: Retrobulbar Block; Procedure: Remifentanil

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 5G2
      • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Retrobulbar block; Retrobulbar block administered prior to Transcleral Diode Procedure	Procedure: Retrobulbar Block; Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure
ACTIVE_COMPARATOR: Remifentanil; Conscious IV sedation administered prior to Transcleral Diode Procedure.	Procedure: Remifentanil; Remifentanil administered as intravenous infusion prior to transcleral diode procedure; Other Names: remifentanil hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Measures of Outcomes of Anesthesia	Complication Rates	1-week

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Delan Jinapriya, MD, Queen's University - School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): October 1, 2017

Study Registration Dates

• First Submitted: September 21, 2015
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (ACTUAL): August 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 18096 (Other Grant/Funding Number: Medical Scientific Fund of the Mayor of Vienna)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED