A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982)
2018年9月17日 更新者：Merck Sharp & Dohme LLC
Randomized, Controlled, Parallel-Group, Double-Blind Trial to Compare the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures Using a 2x2 Factorial Design in Patients Undergoing Laparoscopic Cholecystectomy (Protocol No. MK-8616-076-03 Also Known as SCH 900616, P07982)
The purpose of this pilot study is to compare the use of deep or standard neuromuscular blockade (NMB) in combination with low or standard insufflation pressure in participants undergoing a surgical procedure, laparoscopic cholecystectomy.
Insufflation refers to the injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow visualization of and access to the surgical field.
The primary hypothesis of the study is that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical conditions as compared to standard NMB.
The in-patient surgery is performed on Day 1 and the participant remains hospitalized for at least 48 hours following the surgery (or at least 24 hours following the surgery, if local practice does not allow 48 hours of hospitalization post surgery).
On Day 8, a follow-up visit/contact including all participants occurs.
研究概览
详细说明
During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a "rescue intervention"), if surgeon considered surgical conditions to be unacceptable.
This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mmHg.
If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mmHg.
研究类型
介入性
注册 (实际的)
127
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
- Scheduled to undergo an elective in-patient laparoscopic cholecystectomy procedure under general anesthesia with total intravenous anesthesia (TIVA) using propofol and remifentanil
- Eligible to undergo rocuronium-induced NMB for endotracheal intubation and maintenance of NMB
- Will recover in the post-anesthesia care unit (PACU) and remain in the hospital for at least 48 hours following the surgical procedure (or at least 24 hours following the surgical procedure, if local practice does not allow 48 hours of hospitalization post surgery)
- Body mass index (BMI) ≤35
- Willing and able to adhere to visit schedules including all required study assessments on Day 3 through 8 (daily pain and medication diary entry)
- For sexually active female participants of child-bearing potential - able to use a medically accepted method of contraception through 7 days after receiving protocol-specified medication
Exclusion criteria:
- Neuromuscular disorders that may affect NMB and/or trial assessments
- Lifetime history of previous abdominal surgery, including laparotomies, Cesarean section, laparoscopic procedures or diagnostic laparoscopies
- Substance abuse or dependence (excluding nicotine) within the past 6 months
- History of a chronic pain condition (requiring continuous/daily pain medication prior to surgery)
- For female participants - lifetime history of a Cesarean section, or has given birth to one or more children within the last year, or is currently pregnant or has the intention to become pregnant between randomization and pregnancy follow-up contact ≥30 days after administration of trial treatments (rocuronium, sugammadex)
- Evidence of acute cholecystitis
- Dialysis-dependency or suspected of having severe renal insufficiency
- Significant hepatic dysfunction that would prevent participation in the trial
- History of or family history of malignant hyperthermia
- Allergy to trial treatments (rocuronium or sugammadex) or their excipients, to opioids/opiates, or other medication used during general anesthesia
- Received or is planned to receive toremifene or fusidic acid within 24 hours before or after receiving rocuronium or sugammadex
- Expected transfer to an Intensive Care Unit after surgery
- Any clinically significant condition or situation, other than the reason for the cholecystectomy that would interfere with the trial evaluations or optimal participation in the trial
- Used any investigational drugs within 30 days of randomization
- Participated in any other clinical trial within 30 days of signing the informed consent form of the current trial
- Participated in any other clinical trial involving any personnel of the investigational or Sponsor staff directly involved with this trial
- Is a family member of any personnel of the investigational or Sponsor staff directly involved with this trial
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：Standard NMB and Standard Insufflation Pressure
Treatment condition for this arm is Standard NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
|
NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium.
NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition.
- Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%).
- Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
其他名称：
Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
其他名称：
|
|
实验性的：Standard NMB and Low Insufflation Pressure
Treatment condition for this arm is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
|
NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium.
NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition.
- Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%).
- Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
其他名称：
Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
其他名称：
|
|
实验性的：Deep NMB and Standard Insufflation Pressure
Treatment condition for this arm is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
|
NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium.
NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition.
- Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%).
- Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
其他名称：
Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
其他名称：
|
|
实验性的：Deep NMB and Low Insufflation Pressure
Treatment condition for this arm is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
|
NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium.
NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition.
- Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%).
- Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
其他名称：
Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
其他名称：
|
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 |
|---|---|---|
|
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)
大体时间：End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): "How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?"
If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention).
The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
|
End of surgery (Day 1)
|
|
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm
大体时间：End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): "How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?"
If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention).
The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
|
End of surgery (Day 1)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)
大体时间：Up to 24 hours after administration of sugammadex on Day 1
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.
|
Up to 24 hours after administration of sugammadex on Day 1
|
|
Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm
大体时间：Up to 24 hours after administration of sugammadex on Day 1
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.
|
Up to 24 hours after administration of sugammadex on Day 1
|
|
Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)
大体时间：End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): "How satisfied were you overall with the visual field during the surgery you just performed?"
If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis.
|
End of surgery (Day 1)
|
|
Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)
大体时间：End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): "How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"
|
End of surgery (Day 1)
|
|
Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)
大体时间：End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): "How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"
|
End of surgery (Day 1)
|
|
Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)
大体时间：During surgery, approximate duration of 1-2 hours (Day 1)
|
At the end of the procedure the surgeon responds to the following question: "How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?"
|
During surgery, approximate duration of 1-2 hours (Day 1)
|
|
Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)
大体时间：End of surgery (Day 1)
|
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): "How did the patient movements described above disrupt your surgical performance?"
This refers to participant movements during surgery.
|
End of surgery (Day 1)
|
|
Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm
大体时间：During surgery, approximate duration of 1-2 hours (Day 1)
|
During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a "rescue intervention"), if surgeon considered surgical conditions to be unacceptable.
This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg.
If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg.
The unblinded anesthetist recorded any rescue actions performed.
This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level.
|
During surgery, approximate duration of 1-2 hours (Day 1)
|
|
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm
大体时间：Days 2 to 8
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
This measure summarizes the assessment of overall pain at rest for the study days following the surgery.
|
Days 2 to 8
|
|
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm
大体时间：Days 2 to 8
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
This measure summarizes the assessment of provoked pain for the study days following the surgery.
|
Days 2 to 8
|
|
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm
大体时间：Days 2 to 8
|
Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain).
Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest.
This measure summarizes the assessment of shoulder pain for the study days following the surgery.
|
Days 2 to 8
|
|
Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm
大体时间：Up to Day 8
|
Post operative use of pain/analgesic medication by participant through Day 8 was recorded.
|
Up to Day 8
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2012年11月28日
初级完成 (实际的)
2014年4月29日
研究完成 (实际的)
2014年4月29日
研究注册日期
首次提交
2012年10月16日
首先提交符合 QC 标准的
2012年11月13日
首次发布 (估计)
2012年11月20日
研究记录更新
最后更新发布 (实际的)
2018年10月17日
上次提交的符合 QC 标准的更新
2018年9月17日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.