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

NCT03646500 | Completed

• 1 other identifier: 18096
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Core Measures of Outcomes of Anesthesia

  1-week

Study Arms (2)

Retrobulbar block

EXPERIMENTAL

Retrobulbar block administered prior to Transcleral Diode Procedure

Procedure: Retrobulbar Block

Remifentanil

ACTIVE COMPARATOR

Conscious IV sedation administered prior to Transcleral Diode Procedure.

Procedure: Remifentanil

Interventions

Retrobulbar Block PROCEDURE

Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure

Retrobulbar block

Remifentanil PROCEDURE

Remifentanil administered as intravenous infusion prior to transcleral diode procedure

Also known as: remifentanil hydrochloride

Remifentanil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Delan Jinapriya, MD

  Queen's University - School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Dept. of Ophthalmology); Eye Physician and Surgeon; Glaucoma Subspecialist

Model Details: 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).

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: August 24, 2018
• Study Start: July 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

CA (1)