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
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Procedure: Retrobulbar Block Procedure: Remifentanil||Not Applicable|
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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|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)|
|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|
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.
Remifentanil administered as intravenous infusion prior to transcleral diode procedure
Other Name: remifentanil hydrochloride
- 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).
- Core Measures of Outcomes of Anesthesia [ Time Frame: 1-week ]Complication Rates
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
|Hotel Dieu Hospital|
|Kingston, Ontario, Canada, K7L 5G2|
|Principal Investigator:||Delan Jinapriya, MD||Queen's University - School of Medicine|