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临床试验/NCT03020914
NCT03020914已完成不适用

Effects of Audiovisual Distraction Versus Standard Sedation on Desaturation and Airway Intervention in OSA-patients Undergoing Total Knee Arthroplasty Under Neuraxial Anesthesia

Hospital for Special Surgery, New York0 个研究点目标入组 19 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
主要终点
Desaturations

研究概览

简要总结

Patients will be randomly assigned to either one of two groups:

  1. Standard of care sedation
  2. Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library

Monitoring and anesthesia regimen will be standardized

详细描述

Before consent patients will be thoroughly informed about possible risks or benefits and about their possibilities to end the study at any time point or to ask for additional sedation if they feel uncomfortable or anxious. After they consent, they will be randomly assigned to either receive standard sedation (Group 1) or audiovisual distraction (Group 2). Each group will consist of 30 patients. The randomization schedule will be created by a member of the Healthcare Research Institute using SAS software, who is not otherwise involved in the trial.

  1. Standard of care sedation with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.
  2. Audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.

The intraoperative anesthesia regimen will be standardized:

  • All patients will be monitored according to the American Society of Anesthesiologists standard, receive either a radial arterial line or non-invasive blood pressure measurement according to the preferences of the anesthesia provider and O2 via nasal cannula or face mask in the operation room and the recovery room.

  • ondansetron,decadron and ketorolac may be administered as per clinical judgment of the attending anesthesiologist.

  • Patients in both groups will receive neuraxial anesthesia. The attending anesthesiologist is free to add an ultrasound guided peripheral nerve block:

  • Neuraxial anesthesia (combined spinal-epidural, epidural or spinal) as preferred by the attending anesthesiologist. Decadron may be used as in addition to the local anesthetic if the anesthesia provider wishes to do so.

  • If a peripheral nerve block is performed the appropriate amount of bupivacaine will be administered under ultrasound-guidance as a single shot.

  • In case an epidural catheter was placed patients will receive a patient controlled epidural analgesia immediately after arrival at the recovery room for postoperative pain management.

  • Opioids and other medications with sedative or respiratory depressant side effects that are not specifically mentioned above should be omitted (if possible without harm for the patient) Patients in the audiovisual distraction group will choose a movie, start watching it in the holding area and continue watching it in the operation room as well as the first 30 min in the recovery room. Audiovisual equipment will be removed for transfers or at patient request.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •Patients with known OSA (preexisting diagnosis of obstructive sleep apnea (OSA) or patients with a STOP BANG Score of 5 or above) undergoing primary total knee arthroplasty under neuraxial anesthesia

排除标准

  • •Contraindications to neuraxial anesthesia or allergy to study medication
  • •Patients with audiovisual impairments prohibiting them from proper use of the study device:
  • •Patients who are blind
  • •Patients with hearing aids
  • •Age <18 years
  • •Patients with inability to communicate in English or understand the study requirements
  • •Patients with prior history of claustrophobia
  • •Patients with prior history of epilepsy or seizure disorder
  • •Patients undergoing a revision

研究组 & 干预措施

Standard of care sedation

No Intervention

Standard of care sedation with with a initial dose of midazolam in preparation for the administration of the neuraxial anesthesia; propofol infusion titrated to effect.

Audiovisual Distraction

Experimental

Patients get audiovisual distraction during surgery and in the recovery room using video goggles and headphones; patients can choose a movie from a preexisting library; with an initial dose of midazolam in preparation for the administration of the neuraxial anesthesia, additional sedation with midazolam in 1 mg increments if requested by the patient or deemed necessary by the anesthesia provider.

干预措施: Audiovisual Distraction (Device)

结局指标

主要结局

Desaturations

时间窗: start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours)

number of desaturation events (SpO2\< 90% for ≥ 10 sec) measured during this time frame

次要结局

  • Airway Interventions(start of anesthesia until 30 minutes after recovery room admission (ca. 3 hours))
  • Additional Sedation(intraoperative)
  • Patient Satisfaction(10 minutes before recovery room discharge)
  • Alertness Levels(4 times: preoperative, intraoperative, at time of recovery room admission, 10 minutes before recovery room discharge)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

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