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临床试验/NCT03251222
NCT03251222Unknown4 期

Intranasal Sedation With Dexmedetomidine for Vitroretinal Procedures

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
40
试验地点
1
主要终点
remifentanil consuption

研究概览

简要总结

For patients with eye surgery and shorter surgery, sedation is a well-established method in preserved consciousness and has been successfully used for several years. We have also developed and published a valid protocol (1).

Remifentanil is used in intravenous infusion for sedation and anxiolysis. Remifentanil is a descriptive analgesic, which also works partially anxiolytically. In eye surgery, it is important that the patient cooperates during the operation and should not be ashamed, as injury to the eye could occur, because the vitrectomes are performed with a fine intraocular endoscopic technique, in which the operator inserts his instruments through the whiteness into the eye. For this reason, we have not yet added additional sedatives (for example, midazolam), which is very unpredictable as regards sedation. Remifentanil is also very unpredictable and it is very difficult to control it during the operation so that the patient is saturated with satisfaction.

Lately, dexmedetomidine has been successfully used in sedation for other areas of surgery (eg neurosurgery, maxillofacial surgery, ORL). It is a safe, proven, active substance with alpha 2 agonistic effect, which has not yet been used in the field of ocular surgery and has not yet published articles in this field. The substance is very suitable because it works mildly sedative and at the same time analgesic.

详细描述

For patients with eye surgery and shorter surgery, sedation is a well-established method in preserved consciousness and has been successfully used for several years. We have also developed and published a valid protocol (1).

Remifentanil is currently used for intravenous infusion for analgesia and anxiolysis. Remifentanil is an opioid analgesic, which also works partially anxiolytically. It has been studied in detail for postnatal analgesia (2). In eye surgery, it is important that the patient cooperates during the operation and should not be ashamed, as injury to the eye could occur, because the vitrectomes are performed with a fine intraocular endoscopic technique, in which the operator inserts his instruments through the whiteness into the eye. For this reason, we have not yet added additional sedatives (for example, midazolam), which is very unpredictable and a rapidly shallow sedation can pass into the deeper. Remifentanil is also very unpredictable and it is very difficult to control it during the operation, so that the patient is satisfactorily analgesized at all times, but still co-operable.

Recently, dexmedetomidine (3-5) has been successfully used in other areas of surgery (eg neurosurgery, maxillofacial surgery, ORL) and intensive sedation therapies. It is a safe, proven, active substance with alpha 2 agonistic effect, which has not yet been used in the field of ocular surgery and has not yet published articles in this field. The substance is very suitable because it works mildly sedative and at the same time analgesic (3).

Dexmedetomidine is predominantly administered intravenously, and intranasal administration (6-8) has also been established in pediatric patients.

We decided to use intranasal use because it is simple, safe and suitable for such treatments because intravenous dexmedetomidine could not be administered because it should be given enough time before surgery (at least 40 min) because otherwise the appropriate effect . Patients for such operations will enter the operating room directly from the departments on foot and dexmedetomidine could not be started earlier, as it is not possible to provide adequate control in the department. A sedentary patient would also not be able to walk into an operational one, which would greatly complicate and also increase logistics.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who will be operated on the eye (vitreoretinal interventions) patients with ASA status 1-3

排除标准

  • patients who will not want to be operated in the sedation but in general anesthesia
  • poor general condition (ASA> 3)
  • with severe cardiac disease (NYHA> 3)
  • with severe pulmonary obstructive disease (FEV1 <40%)
  • neurological diseases
  • psychiatric patients
  • patients receiving regular psychotropic treatment

研究组 & 干预措施

Dexmedetomidine group

Experimental

Patients who will receive Dexmedetomidine intranasal prior the sedation with remifentanil

干预措施: Dexmedetomidine (Drug)

Placebo Concentrate

Placebo Comparator

Patients will recive 0.9% NaCl

干预措施: Placebo - Concentrate (Other)

结局指标

主要结局

remifentanil consuption

时间窗: duration of the procedure

the consuption of remifentanil requiered to reach the appropriate sedation will be meassured

次要结局

  • Oxigen Saturation(duration of the procedure)

研究者

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

Iztok Potocnik

M.D., PHD

University Medical Centre Ljubljana

研究点 (1)

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