GlaucomaNCT03646500
Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser
A study testing Retrobulbar Block and Remifentanil in people with Glaucoma, run by Queen's University at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Retrobulbar Block and Remifentanil
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- pregnancy
- inability to consent
- under 18 years of age
- not eligible for conscious sedation and/or retrobulbar block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Glaucoma
- Being tested
- Retrobulbar Block, Remifentanil
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrobulbar BlockProcedure or surgery
Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure
RemifentanilProcedure or surgery
Also called remifentanil hydrochloride
Remifentanil administered as intravenous infusion prior to transcleral diode procedure
| Study group | Role | What they receive |
|---|---|---|
| Retrobulbar block | Experimental | Retrobulbar block administered prior to Transcleral Diode Procedure Receives: Procedure: Retrobulbar Block |
| Remifentanil | Active comparator | Conscious IV sedation administered prior to Transcleral Diode Procedure. Receives: Procedure: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1-week
Secondary outcomes (1)
Core Measures of Outcomes of Anesthesia
Complication Rates
Measured: 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study startJul 2015
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Delan Jinapriya, Queen's University
- Investigators
- Delan Jinapriya, MD, Principal investigator, Queen's University - School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646500
- Sponsor's protocol ID
- 18096
- Status last verified
- Aug 2018
- First submitted
- 21 Sep 2015
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser
- ClinicalTrials.gov ID
- NCT03646500
- Acronym / sponsor ID
- 18096
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Retrobulbar block | Experimental | Procedure: Retrobulbar BlockRetrobulbar block administered prior to Transcleral Diode Procedure |
| Remifentanil | Active comparator | Procedure: RemifentanilConscious IV sedation administered prior to Transcleral Diode Procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- pregnancy
- inability to consent
- under 18 years of age
- not eligible for conscious sedation and/or retrobulbar block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrobulbar BlockAnesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure | Procedure or surgery | Retrobulbar block |
| RemifentanilAlso: remifentanil hydrochlorideRemifentanil administered as intravenous infusion prior to transcleral diode procedure | Procedure or surgery | Remifentanil |
Primary outcome
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).
1 secondary outcome
Core Measures of Outcomes of Anesthesia
Time frame: 1-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delan Jinapriya, MD principal investigator
Queen's University - School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrobulbar Block and Remifentanil in people with Glaucoma, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leiden Perioperative Care Patient Satisfaction Questionnaire (time frame: 1-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.