跳至主要内容
临床试验/NCT02469961
NCT02469961已完成4 期

Dexmedetomidine vs Propofol TIVA and Interscalene Block for Shoulder Surgeries in a Beach Chair Sitting Position

Maimonides Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Number of Participants That Need an Airway Intervention.

研究概览

简要总结

The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol.

The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for this study.

Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

详细描述

The anesthesia provided during shoulder surgery commonly uses a combination of regional and intravenous (IV) anesthetic medications. The current drug of choice for IV sedation is Propofol. Although. it is a good anesthetic, incidence of intermittent apnea makes the use of it problematic in cases where the head of the patient is less accessible to the anesthesiologist, as is in sitting beach char position. Dexmedetomidine is a FDA approved drug, which has a very stable cardiovascular and respiratory profile. It has been successfully used for Neurological and Vascular cases and in Intensive care units. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators' will enroll 50 patients for this study. Using a computer program the participants will be randomized into two equal groups to receive either Dexmedetomidine or Propofol.

The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol.

Dexmedetomidine infusion is initiated with a bolus of 1 mcg/kg is given over 10 min as patient is being positioned, and the sedation is maintained with Dexmedetomidine at 0.7- 1.0 mcg/kg/hr during the surgery. Propofol infusion is started at 100mcg/kg/min, and maintained with Propofol at 50-120mcg/kg/min, during the surgery.

In each group the investigators will record the incidence of respiratory depression/hypoxia, hemodynamic stability, frequency of airway manipulation, cardiovascular effects, need for anesthetic supplementation of Dexmedetomidine, post anesthesia care unit (PACU) discharge time, the need for postoperative pain medication, post operative complications, like nausea/vomiting.

Significant differences between the two groups will be evaluated using unpaired t-test for numerical variables, and Chi-square test or Z test for categorical variables.

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
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants scheduled for shoulder arthroscopies in the beach chair sitting position.
  • Participants who received a successful interscalene block.

排除标准

  • Failed interscalene block. Refusal to participate in the study. Allergy to the study drugs. Participants that need a secure airway.

研究组 & 干预措施

dexmedetomidine

Experimental

Participants will receive an interscalene block and be sedated with dexmedetomidine

干预措施: Dexmedetomidine (Drug)

dexmedetomidine

Experimental

Participants will receive an interscalene block and be sedated with dexmedetomidine

干预措施: Interscalene block (Other)

Propofol

Active Comparator

Participants will receive an interscalene block and be sedated with propofol

干预措施: Propofol (Drug)

Propofol

Active Comparator

Participants will receive an interscalene block and be sedated with propofol

干预措施: Interscalene block (Other)

结局指标

主要结局

Number of Participants That Need an Airway Intervention.

时间窗: Participants will be followed from the start of sedation until discharge: approximately 3-5 hr

airway manipulation or repositioning: apnea, oral airway, adjust head

次要结局

  • Number of Participants That Have Either Bradycardia or Hypotension(Participants will be followed from the start of sedation until discharge: approximately 3-5 hr)
  • Post Anesthesia Care Unit (PACU) Length of Stay(Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation)
  • Total Narcotic Used by Each Participant(Participants will be followed from the start of sedation until discharge: approximately 3-5 hr)

研究者

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

Piyush Gupta, MD

Clinical Director

Maimonides Medical Center

研究点 (1)

Loading locations...

相似试验