Neuromuscular Blockade on Shoulder Pain of Elderly
The Effect of Deep Neuromuscular Blockade With Sugammadex Reversal on Shoulder Pain of Elderly Patients Undergoing Robotic Surgery: A Single-Center Double-Blinded Randomized Controlled Trial
Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP.
In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon.
To reverse the effects of NMB after surgery, a drug called neostigmine is given.
The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given.
This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery.
Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
研究概览
地位
详细说明
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups before your surgery. This is done because no one knows if one group is better, the same, or worse than the other.
- In Group 1, you will receive deep NMB and Sugammadex.
- In Group 2, you will receive moderate NMB and neostigmine.
Neither you nor the surgeon or surgical staff will know to which group you have been assigned. The surgeon will not know which group you are in because researchers want to learn how much, if at all, the surgeon needs to adjust the insufflation pressure during surgery. However, if needed for your safety, the surgeon will be able to find out which group you are in.
For your safety, the anesthesiologist will know to which group you have been assigned.
Surgery and Study Drug Administration:
After you have been assigned to a study group, you will have your surgery as scheduled. You will sign a separate consent form for surgery which describes the procedure and its risks in more detail. You will also sign a separate consent form to receive anesthesia.
Before your surgery, blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood/tissue and may be related to the status of the disease and/or your reaction to the study drug(s).
During the surgery, the insufflation pressure that is being used, including any changes that are made to the pressure, will be recorded. After the surgery has been completed, you will receive either Sugammadex or neostigmine by vein until the effects of the NMB have been reversed.
You will recover after surgery in the post-anesthesia care unit (PACU). At about 15, 45, and 90 minutes after your surgery, a PACU nurse will ask you about any shoulder pain you are feeling and if so, how intense the pain is. Information about how long you stay in the hospital after surgery and if you have any side effects after surgery (such as nausea/vomiting or shoulder pain) will also be collected from your medical record.
Follow-Up:
After 30 days after you leave the hospital, you will be called by a member of the study staff to ask how you are doing and if you have had any additional hospitalizations since leaving the hospital. This phone call should last about 5-10 minutes.
Length of Study Participation:
Your participation in this study will be over after completing the 30-day follow up phone call.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Texas
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Houston、Texas、美国、77030
- University of Texas MD Anderson Cancer Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients 65 years of age or older
- Patients having robotic prostatectomy
- Written informed consent
Exclusion Criteria:
- Patient with known hypersensitivity to Rocuronium, Sugammadex or its components
- Patients with severe renal insufficiency, defined and confirmed by an estimated creatinine clearance equal or lower than 30 mL/min, per institutional laboratory.
- Patients with history of severe liver disease, defined as and confirmed by elevated ALT and AST greater than 1.5 times the Upper Limit of Normal along with Albumin less than 3 OR INR 1.5 or greater per institutional laboratory.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Deep Neuromuscular Blockade (NMB) + Sugammadex
Deep Neuromuscular Blockade (NMB) given during surgery. Sugammadex intravenously as a single bolus injection after surgery. Pain assessment done at about 15, 45, and 90 minutes after surgery. |
Deep Neuromuscular Blockade (NMB) given during surgery.
4 mg/Kg, intravenously as a single bolus injection after surgery.
Pain assessment done at about 15, 45, and 90 minutes after surgery.
其他名称：
|
|
实验性的：Moderate Neuromuscular Blockade (NMB) + Neostigmine
Moderate Neuromuscular Blockade (NMB) given during surgery. Neostigmine intravenously slowly over a period of at least 1 minute after surgery. Pain assessment done at about 15, 45, and 90 minutes after surgery. |
Pain assessment done at about 15, 45, and 90 minutes after surgery.
其他名称：
Moderate Neuromuscular Blockade (NMB) given during surgery.
70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Patients Who Reported Shoulder Pain
大体时间：30 days
|
Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced .
Percentage of participants who experienced should pain.
|
30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative Intraoperative Insufflation Pressure
大体时间：Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)
|
Intra-abdominal insufflation time and pressure directed by the surgeon and recorded continuously by the clinical coordinator until the time of desufflation.
|
Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)
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Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation
大体时间：Day 0 - Arrival time at PACU, an average of 3 minutes
|
The patients will be started on a continuous Rocuronium intravenous infusion following intubation.
Insert recommendations and Institutional Standards will be used for Rocuronium.
For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum.
NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery.
Percentage of measured contraction strength of the fourth stimulus compared to the first stimulus.
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Day 0 - Arrival time at PACU, an average of 3 minutes
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Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)
大体时间：Assessed at 15, 45, 90 minutes during PACU stay.
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Determined by the Dansk Selskab for Anæstesiologi og Intensiv Medicin(DASAIM)discharge criteria.Pts considered ready to discharge when the sum of all categories is<4 and no single category has a score of >1.Sedation.0:Patient is fully awake.1:
Patient is asleep,aroused by verbal stimulation.2:Patient is asleep, aroused by physical stimulation.3:Patient is asleep,cannot be aroused.Respiratory Rate.0:Respiratory rate>10.
1: Snoring,10< RR<30.
2:R<10 or RR>30/min.3:Periods of apnea or obstructive patterns.Oxygen Saturation.0:SpO2 ≥ 94%.1:90%≤SpO2<94%.
2:85%≤ SpO2 < 90%.3:SpO2 < 85%.
Systolic Blood Pressure.
0:SBP ≥ 100mmHg.1:90mmHg≤SBP<
100mmHg.2:80mmHg≤SBP<
90mmHg or SBP>220mmHg.3:SBP<80mmHg.Heart Rate.0:50<HR≤100.1:100<HR≤120.2:40<HR≤
50 or 120<HR≤130.3:HR<40 or HR>130.Pain at rest.0:No pain 1:Light pain.2:Moderate
pain.3:Severe
pain.Nausea.0:No
nausea or vomiting.1:Light
nausea or vomiting without previous nausea.
2:Moderate nausea and/or vomiting.3:Severe
nausea and/or vomiting.
|
Assessed at 15, 45, 90 minutes during PACU stay.
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Percentage of Participants With Nausea and/or Vomiting in PACU
大体时间：Day 0 - PACU stay, an average of 120 minutes
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Degree of Post-Operative Nausea determined per Visual Analog Scale per nurse in Post-Anesthesia Care Unit (PACU).
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Day 0 - PACU stay, an average of 120 minutes
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Surgical Exposure Grading
大体时间：Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)
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Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)
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Length of Hospital Stay
大体时间：length of hospital stay(average of 3 days)
|
length of hospital stay(average of 3 days)
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合作者和调查者
调查人员
- 首席研究员：Wendell H. Williams III, MD、M.D. Anderson Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2017-0046 (其他标识符：Institutional Review Board)
- NCI-2018-01176 (注册表标识符：NCI CTRP)
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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