Prospective Randomized Trial of Moderate vs Deep Neuromuscular Blockade During Laparoscopic Ventral Hernia Repair
The proposed study aims to assess the effect of different levels of muscle relaxation on the success of low-pressure insufflation, surgical conditions and patient recovery following laparoscopic repair of a ventral hernia (VHR) between 2 and 10cm in diameter. Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation.
Specific Aim 1. Compare two different modes of neuromuscular blockade (moderate and deep) on the ability to maintain low insufflation pressure during laparoscopic VHR. All procedures will start with low-pressure insufflation (8 mm Hg). Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale. If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg. Outcome for this specific aim will be the mean insufflation pressure during each procedure, and the ability to perform low-pressure laparoscopic VHR.
Specific Aim 2. Evaluate the success of moderate neuromuscular blockade on the ability to maintain good conditions (visual scale grade 4 or 5) for each. Surgical conditions will be considered successful when scores are maintained at 4 or 5 throughout the duration of the procedure. Outcome for this aim will be the mean score for surgical condition assessment for each procedure, using a previously published surgeon-driven scoring system (score 4-5 will be used as a surrogate of good visualization).
Specific Aim 3. Assess patient recovery with low and high insufflation pressures during laparoscopic VHR. Patient overall satisfaction with recovery, pain level, pain medication requirement, PONV incidence and severity will be assessed in multiple time points following surgery. Outcomes for this aim will be mean pain (visual scale), PONV severity (analogue score) and incidence (binary outcome), and patient satisfaction using the QoR-15 survey. Assessments will be performed at 30 minutes, 1, 12 and 24 hours following surgery.
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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Stony Brook、New York、美国、11794-8191
- 招聘中
- Shabana Humayon
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接触:
- Shabana Humayon
- 电话号码:631-532-7167
- 邮箱:shabana.humayon@stonybrookmedicine.edu
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首席研究员:
- Konstantinos Spaniolas
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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 age 18-75 years old
- Umbilical, ventral, epigastric, spigelian or incisional hernia
- Plan for laparoscopic ventral hernia repair with mesh
- Estimated fascial defect between 2-10 cm in maximum diameter
Exclusion Criteria:
- Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
- Inability to provide informed consent
- Body mass index of 35 or over
- Multiple recurrent hernias (>1)
- Creatinine clearance < 30 ml/min (using the Cockcroft-Gault calculation)
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Moderate Neuromuscular Block
Train of four count of 1-2.
All procedures will start with low-pressure insufflation (8 mm Hg).
Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale.
If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg.
Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice.
In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
|
All procedures will start with low insufflation pressure (8 mmHg).
Surgical field assessment (scale 1-5) will be performed every 5 minutes (Martini Br J Anaesth 2014).
If conditions are poor (rating 1-2), intraperitoneal insufflation will be incrementally increased (10 mmHg, 12 mmHg, 15 mmHg) every 5 minutes as needed.Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice.
In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
|
实验性的:Deep Neuromuscular Block
Post tetanic count of 1-2.
All procedures will start with low-pressure insufflation (8 mm Hg).
Surgeon assessment of the conditions will be serially performed during surgery on an established visual scale.
If conditions are deemed less than adequate (score 1-2), insufflation pressure will incrementally increase up to 15 mm Hg.
Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice.
In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
|
All procedures will start with low insufflation pressure (8 mmHg).
Surgical field assessment (scale 1-5) will be performed every 5 minutes (Martini Br J Anaesth 2014).
If conditions are poor (rating 1-2), intraperitoneal insufflation will be incrementally increased (10 mmHg, 12 mmHg, 15 mmHg) every 5 minutes as needed.Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice.
In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Mean insufflation pressure during each procedure as a continuous variable
大体时间:will be assessed every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
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will be assessed every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
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次要结果测量
结果测量 |
大体时间 |
---|---|
Surgical condition assessment
大体时间:every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
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every 5 minutes during surgery (while subject is undergoing laparoscopic ventral hernia repair)
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PONV severity (analogue score) and incidence (binary)
大体时间:it will be assessed at 30 minutes, 1 hour, 12 hours and 24 hours after the completion of laparoscopic ventral hernia repair
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it will be assessed at 30 minutes, 1 hour, 12 hours and 24 hours after the completion of laparoscopic ventral hernia repair
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Patient satisfaction (QoR-15).
大体时间:it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair
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it will be assessed 24 hours after the completion of laparoscopic ventral hernia repair
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合作者和调查者
调查人员
- 首席研究员:Konstantinos Spaniolas, MD、StonyBrook University Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
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