Clinical Trial: 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)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Factoria

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 Summary: 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.
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Score on surgeon's rating of overall satisfaction with the surgical conditions [ 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?"


Current Secondary Outcome:

  • 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) [ Time Frame: 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.
  • Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm [ Time Frame: 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.
  • Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep) [ 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, 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.
  • Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep) [ 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, unacceptable muscle relaxation, required intervention) to 10 (excellent): "How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"
  • Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep) [ 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, unacceptable insufflation pressure, required intervention) to 10 (excellent): "How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"
  • Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep) [ Time Frame: 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?"
  • 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) [ 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 (extremely disruptive) to 10 (not disruptive): "How did the patient movements described above disrupt your surgical performance?" This refers to participant movements during surgery.
  • Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm [ Time Frame: 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 pressu

    Original Secondary Outcome:

    • Participant's overall reported pain within 24 hours after administration of sugammadex [ Time Frame: Up to 24 hours after administration of sugammadex on Day 1 ]
    • Score on surgeon's rating of overall satisfaction with the visibility of the surgical field [ 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, unacceptable visibility) to 10 (excellent): "How satisfied were you overall with the visual field during the surgery you just performed?"
    • Score on surgeon's rating of the overall adequacy of muscle relaxation during surgery [ 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, unacceptable muscle relaxation, required intervention) to 10 (excellent): "How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"
    • Score on surgeon's rating of the overall adequacy of insufflation pressure during surgery [ 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, unacceptable insufflation pressure, required intervention) to 10 (excellent): "How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"
    • Number of times participant's movements or increased muscle tone interfered with the surgical conditions during laparoscopy [ Time Frame: 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 [ 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 (extremely disruptive) to 10 (not disruptive): "How did the patient movements described above disrupt your surgical performance?" This refers to participant movements during surgery.
    • Number of rescue actions performed during surgery in order to improve insufficient surgical conditions [ Time Frame: During surgery, approximate duration of 1-2 hours (Day 1) ]
    • Daily assessments of participant's reported overall pain [ Time Frame: Days 2 to 8 ]
    • Post operative use of analgesic medications [ Time Frame: Up to Day 8 ]


    Information By: Merck Sharp & Dohme Corp.

    Dates:
    Date Received: October 16, 2012
    Date Started: November 2012
    Date Completion:
    Last Updated: May 11, 2015
    Last Verified: May 2015