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)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 2
- 主要终点
- Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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).
干预措施: Rocuronium (Drug)
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).
干预措施: Insufflation (Other)
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).
干预措施: Sugammadex (Drug)
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).
干预措施: Rocuronium (Drug)
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).
干预措施: Insufflation (Other)
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).
干预措施: Sugammadex (Drug)
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).
干预措施: Rocuronium (Drug)
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).
干预措施: Insufflation (Other)
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).
干预措施: Sugammadex (Drug)
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).
干预措施: Rocuronium (Drug)
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).
干预措施: Insufflation (Other)
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).
干预措施: Sugammadex (Drug)
结局指标
主要结局
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm
时间窗: 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.
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)
时间窗: 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.
次要结局
- 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)(Up to 24 hours after administration of sugammadex on Day 1)
- Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm(During surgery, approximate duration of 1-2 hours (Day 1))
- Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)(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)(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)(During surgery, approximate duration of 1-2 hours (Day 1))
- Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)(End of surgery (Day 1))
- Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm(Up to Day 8)
- Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm(Up to 24 hours after administration of sugammadex on 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)(End of surgery (Day 1))
- Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm(Days 2 to 8)
- Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm(Days 2 to 8)
- Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm(Days 2 to 8)