跳至主要内容
临床试验/NCT03646500
NCT03646500已完成不适用

Prospective Randomized Controlled Trial Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser

Queen's University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Leiden Perioperative Care Patient Satisfaction Questionnaire

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

研究组 & 干预措施

Retrobulbar block

Experimental

Retrobulbar block administered prior to Transcleral Diode Procedure

干预措施: Retrobulbar Block (Procedure)

Remifentanil

Active Comparator

Conscious IV sedation administered prior to Transcleral Diode Procedure.

干预措施: Remifentanil (Procedure)

结局指标

主要结局

Leiden Perioperative Care Patient Satisfaction Questionnaire

时间窗: 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).

次要结局

  • Core Measures of Outcomes of Anesthesia(1-week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Delan Jinapriya

Assistant Professor (Dept. of Ophthalmology); Eye Physician and Surgeon; Glaucoma Subspecialist

Queen's University

研究点 (2)

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