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

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ClinicalTrials.gov Identifier: NCT03646500
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Delan Jinapriya, Queen's University

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.

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Retrobulbar Block Procedure: Remifentanil Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser
Study Start Date : July 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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 Name: remifentanil hydrochloride




Primary Outcome Measures :
  1. Leiden Perioperative Care Patient Satisfaction Questionnaire [ Time Frame: 1-week ]
    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 :
  1. Core Measures of Outcomes of Anesthesia [ Time Frame: 1-week ]
    Complication Rates



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646500


Locations
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Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: Delan Jinapriya, MD Queen's University - School of Medicine

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Responsible Party: Delan Jinapriya, Assistant Professor (Dept. of Ophthalmology); Eye Physician and Surgeon; Glaucoma Subspecialist, Queen's University
ClinicalTrials.gov Identifier: NCT03646500     History of Changes
Other Study ID Numbers: 18096
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Remifentanil
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents