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)
Overview
- Phase
- Phase 4
- Intervention
- Rocuronium
- Conditions
- Gallbladder Disease
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 127
- Locations
- 2
- Primary Endpoint
- Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
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).
Intervention: Rocuronium
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).
Intervention: Insufflation
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).
Intervention: Sugammadex
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).
Intervention: Rocuronium
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).
Intervention: Insufflation
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).
Intervention: Sugammadex
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).
Intervention: Rocuronium
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).
Intervention: Insufflation
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).
Intervention: Sugammadex
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).
Intervention: Rocuronium
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).
Intervention: Insufflation
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).
Intervention: Sugammadex
Outcomes
Primary Outcomes
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
- 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)