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临床试验/NCT04793022
NCT04793022Enrolling By Invitation4 期

A Prospective Clinical Trial Comparing General Anesthesia With Interscalene Nerve Block vs. Deep Sedation Via TIVA-P With Interscalene Nerve Block in Outpatient Shoulder Arthroscopies

Carilion Clinic1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2021年2月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
Enrolling By Invitation
入组人数
192
试验地点
1
主要终点
Time to meet discharge criteria

研究概览

简要总结

This study is comparing total intravenous anesthesia with propofol with a regional nerve block against general anesthesia with a regional nerve block on the primary endpoint of time to meet discharge criteria.

详细描述

The primary objective of this study is to determine if using Total Intravenous Anesthesia with Propofol (TIVA-P sedation) with a regional nerve block will decrease the time to meet discharge criteria. This will be done with patients undergoing shoulder arthroscopic procedures at the Roanoke Ambulatory Surgical Center. Currently, inhaled general anesthesia (GA) with a regional nerve block is utilized for these outpatient arthroscopic procedures. This involves the patient receiving Propofol through an IV to put a patient to sleep, followed by intubation (breathing tube in throat) and the administration of inhaled anesthesia for the duration of the procedure. Another approach for anesthesia in these procedures is TIVA-P sedation. In this protocol the patient receives the same initial amount of Propofol through the IV as they would if they were getting general anesthesia. Once they are asleep, it is maintained with a continuous intravenous administration of Propofol. With this approach, the patient is not intubated and exposed to the same anesthetic agents as general anesthesia. As a result, the patient may not experience the potential side effects associated with general anesthesia. We believe that this will lead to a faster time to meet discharge criteria and also fewer of anesthetic side effects.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-75 years of age
  • Candidate for a shoulder arthroscopic procedure in the beach chair position

排除标准

  • American Society of Anesthesiologists (ASA) level 4 or above
  • History of brachial plexus injury
  • Chronic Obstructive Pulmonary Disorder
  • Unstable Asthma
  • BMI greater than 40
  • Allergy to local anesthesic (bupivacaine)
  • Contralateral phrenic nerve impairment
  • History of Difficult Airway
  • Poorly Controlled Gastroesophageal Reflux Disease
  • Known Aspiration Risk
  • Surgery not performed at the Roanoke Ambulatory Surgical Center
  • Pregnant patients or patients who have a positive pre-operative human chorionic gonadotropin (beta-HCG) pregnancy test
  • Coagulopathies
  • Allergy to propofol
  • Patient request for specific anesthesia method

研究组 & 干预措施

TIVA-Propofol

Experimental

Intravenous anesthesia with Propofol

干预措施: TIVA with Propofol (Drug)

Inhaled Anesthesia

Active Comparator

General Inhaled Anesthesia

干预措施: Inhaled Anesthesia (Drug)

结局指标

主要结局

Time to meet discharge criteria

时间窗: Immediately after the intervention/procedure/surgery

How long it takes until the patient is ready to be discharged from the PACU

次要结局

  • Surgical time(During the intervention/procedure/surgery)
  • Number of procedures requiring anesthetic intervention during surgery(During the intervention/procedure/surgery)
  • Pain Scale(Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.)
  • post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time(Immediately after the intervention/procedure/surgery)
  • Antiemetic use in PACU(Immediately after the intervention/procedure/surgery)
  • Satisfaction scale(Up to 21 days after procedure.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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