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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Retrobulbar Block
Remifentanil
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Retrobulbar block

Remifentanil

Arm Description

Retrobulbar block administered prior to Transcleral Diode Procedure

Conscious IV sedation administered prior to Transcleral Diode Procedure.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Core Measures of Outcomes of Anesthesia
Complication Rates

Full Information

First Posted
September 21, 2015
Last Updated
August 24, 2018
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT03646500
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Patients undergoing TSD would be recruited from one glaucoma subspecialist's practice. Patient consents to TSD at the eye clinic. 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. Pre-anesthesia consult will be conducted to determine eligibility for both conscious sedation and retrobulbar block. 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). Patients will be randomized to either conscious sedation group, or retrobulbar injection group (control) via an online program. On the day of the surgery, patients will receive a pre-anesthesia questionnaire (questions include basic identifying, health and surgery information). Patients will receive a post-surgery questionnaire one hour after the surgery, in the recovery room. Patients will receive a phone call for a post-recovery questionnaire 24 hours later. Patients will receive a recovery and complications questionnaire one week later at the clinic (during check-up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retrobulbar block
Arm Type
Experimental
Arm Description
Retrobulbar block administered prior to Transcleral Diode Procedure
Arm Title
Remifentanil
Arm Type
Active Comparator
Arm Description
Conscious IV sedation administered prior to Transcleral Diode Procedure.
Intervention Type
Procedure
Intervention Name(s)
Retrobulbar Block
Intervention Description
Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure
Intervention Type
Procedure
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
remifentanil hydrochloride
Intervention Description
Remifentanil administered as intravenous infusion prior to transcleral diode procedure
Primary Outcome Measure Information:
Title
Leiden Perioperative Care Patient Satisfaction Questionnaire
Description
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).
Time Frame
1-week
Secondary Outcome Measure Information:
Title
Core Measures of Outcomes of Anesthesia
Description
Complication Rates
Time Frame
1-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delan Jinapriya, MD
Organizational Affiliation
Queen's University - School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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