Trial Outcomes & Findings for 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) (NCT NCT01728584)

Last Updated: 2018-10-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

127 participants

Primary outcome timeframe

End of surgery (Day 1)

Results posted on

2018-10-17

Participant Flow

Participants were randomized to 4 arms based on combinations of neuromuscular blockade (NMB) depth and insufflation pressure level. During procedure, blinded surgeon could request that unblinded anesthetist change the randomized treatment conditions ("rescue intervention"), if surgeon considered surgical conditions to be unacceptable.

Participant milestones

Participant milestones
Measure	Standard NMB and Standard Insufflation Pressure Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four \[TOF\] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).	Standard NMB and Low Insufflation Pressure Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).	Deep NMB and Standard Insufflation Pressure Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts \[PTCs\])/Standard insufflation pressure (starting pressure of 12 mmHg).	Deep NMB and Low Insufflation Pressure Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
Overall Study STARTED	36	30	31	30
Overall Study COMPLETED	28	30	30	29
Overall Study NOT COMPLETED	8	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard NMB and Standard Insufflation Pressure Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four \[TOF\] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).	Deep NMB and Standard Insufflation Pressure Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts \[PTCs\])/Standard insufflation pressure (starting pressure of 12 mmHg).	Deep NMB and Low Insufflation Pressure Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
Overall Study Adverse Event	1	0	0
Overall Study Physician Decision	4	1	0
Overall Study Withdrawal by Subject	1	0	0
Overall Study Screen failure	1	0	0
Overall Study Other reason (not specified)	1	0	1

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard NMB and Standard Insufflation Pressure n=36 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).	Standard NMB and Low Insufflation Pressure n=30 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).	Deep NMB and Standard Insufflation Pressure n=31 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).	Deep NMB and Low Insufflation Pressure n=30 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).	Total n=127 Participants Total of all reporting groups
Age, Continuous	46.1 years STANDARD_DEVIATION 17.7 • n=5 Participants	39.1 years STANDARD_DEVIATION 13.6 • n=7 Participants	43.5 years STANDARD_DEVIATION 15.6 • n=5 Participants	46.7 years STANDARD_DEVIATION 13.8 • n=4 Participants	43.9 years STANDARD_DEVIATION 15.5 • n=21 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	9 Participants n=4 Participants	48 Participants n=21 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	19 Participants n=7 Participants	18 Participants n=5 Participants	21 Participants n=4 Participants	79 Participants n=21 Participants

PRIMARY outcome

Timeframe: End of surgery (Day 1)

Population: Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.

Outcome measures

Outcome measures
Measure	Standard NMB n=60 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=60 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=60 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=60 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)	6.83 score on a scale Interval 5.97 to 7.69	7.92 score on a scale Interval 7.05 to 8.8	8.89 score on a scale Interval 8.05 to 9.72	5.87 score on a scale Interval 4.96 to 6.77

PRIMARY outcome

Timeframe: End of surgery (Day 1)

Outcome measures

Outcome measures
Measure	Standard NMB n=30 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=30 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=30 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=30 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm	8.65 score on a acale Interval 7.58 to 9.72	4.99 score on a acale Interval 3.88 to 6.11	9.09 score on a acale Interval 8.82 to 10.17	6.69 score on a acale Interval 5.57 to 7.8

SECONDARY outcome

Timeframe: Up to 24 hours after administration of sugammadex on Day 1

Population: Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.

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.

Outcome measures

Outcome measures
Measure	Standard NMB n=55 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=65 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=71 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=49 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
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)	2.48 score on a scale Interval 2.02 to 2.93	2.83 score on a scale Interval 2.39 to 3.28	2.74 score on a scale Interval 2.34 to 3.15	2.57 score on a scale Interval 2.07 to 3.07

SECONDARY outcome

Timeframe: Up to 24 hours after administration of sugammadex on Day 1

Outcome measures

Outcome measures
Measure	Standard NMB n=32 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=23 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=39 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=26 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm	2.42 score on a scale Interval 1.9 to 2.93	2.62 score on a scale Interval 1.98 to 3.26	3.06 score on a scale Interval 2.56 to 3.57	2.57 score on a scale Interval 1.97 to 3.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard NMB n=60 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=60 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)	6.88 score on a scale Interval 6.02 to 7.75	7.80 score on a scale Interval 6.92 to 8.68	—	—

SECONDARY outcome

Timeframe: 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?"

Outcome measures

Outcome measures
Measure	Standard NMB n=60 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=60 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)	8.05 score on a scale Interval 7.56 to 8.54	8.87 score on a scale Interval 8.37 to 9.37	—	—

SECONDARY outcome

Timeframe: 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?"

Outcome measures

Outcome measures
Measure	Standard NMB n=60 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=60 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)	6.73 score on a scale Interval 6.01 to 7.45	7.86 score on a scale Interval 7.12 to 8.59	—	—

SECONDARY outcome

Timeframe: 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?"

Outcome measures

Outcome measures
Measure	Standard NMB n=60 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=59 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)	0.92 instances of occurrence that interfered Interval 0.33 to 1.52	0.32 instances of occurrence that interfered Interval -0.29 to 0.92	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard NMB n=60 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=60 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
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)	9.21 score on a scale Interval 8.72 to 9.7	9.94 score on a scale Interval 9.45 to 10.44	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard NMB n=31 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=30 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=31 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=30 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm Number with rescue action performed	0 participants	7 participants	0 participants	5 participants
Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm Number with rescue change in depth of NMB	0 participants	5 participants	0 participants	0 participants
Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm Number with rescue change in pressure level	0 participants	6 participants	0 participants	5 participants

SECONDARY outcome

Timeframe: Days 2 to 8

Population: Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.

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.

Outcome measures

Outcome measures
Measure	Standard NMB n=33 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=23 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=40 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=26 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm 24 hours after sugammadex dose (n=29, 22, 38, 25)	1.66 score on a scale Standard Deviation 1.45	2.23 score on a scale Standard Deviation 2.09	2.24 score on a scale Standard Deviation 1.62	2.48 score on a scale Standard Deviation 2.20
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm 48 hours after sugammadex dose (n=27, 22, 33, 23)	1.22 score on a scale Standard Deviation 1.45	1.41 score on a scale Standard Deviation 1.68	1.73 score on a scale Standard Deviation 1.53	1.83 score on a scale Standard Deviation 1.64
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm Day 3 (N=22, 20, 30, 17)	0.86 score on a scale Standard Deviation 0.89	1.65 score on a scale Standard Deviation 1.76	1.87 score on a scale Standard Deviation 1.59	2.00 score on a scale Standard Deviation 1.84
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm Day 4 (N=28, 20, 37, 23)	0.89 score on a scale Standard Deviation 1.23	1.05 score on a scale Standard Deviation 1.50	1.76 score on a scale Standard Deviation 1.55	1.04 score on a scale Standard Deviation 1.46
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm Day 5 (N=27, 21, 38, 24)	0.89 score on a scale Standard Deviation 1.01	1.00 score on a scale Standard Deviation 1.48	1.45 score on a scale Standard Deviation 1.35	0.92 score on a scale Standard Deviation 1.02
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm Day 6 (N=27, 20, 35, 24)	0.56 score on a scale Standard Deviation 0.75	0.85 score on a scale Standard Deviation 1.39	1.31 score on a scale Standard Deviation 1.55	0.75 score on a scale Standard Deviation 0.90
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm Day 7 (N=27, 21, 34, 22)	0.48 score on a scale Standard Deviation 0.64	0.95 score on a scale Standard Deviation 1.43	1.18 score on a scale Standard Deviation 1.57	0.59 score on a scale Standard Deviation 0.85
Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm Day 8 (N=28, 21, 35, 21)	0.54 score on a scale Standard Deviation 0.79	0.81 score on a scale Standard Deviation 1.29	0.94 score on a scale Standard Deviation 1.24	0.43 score on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard NMB n=33 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=23 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=40 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=26 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm 48 hours after sugammadex dose (n=27, 22, 33, 23)	2.67 score on a scale Standard Deviation 1.96	2.14 score on a scale Standard Deviation 2.19	2.94 score on a scale Standard Deviation 2.08	2.91 score on a scale Standard Deviation 1.83
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm Day 5 (N=27, 21, 38, 24)	1.93 score on a scale Standard Deviation 1.54	1.90 score on a scale Standard Deviation 1.84	2.58 score on a scale Standard Deviation 1.90	1.71 score on a scale Standard Deviation 1.46
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm 24 hours after sugammadex dose (n=29, 22, 38, 25)	3.38 score on a scale Standard Deviation 2.37	3.27 score on a scale Standard Deviation 2.76	3.68 score on a scale Standard Deviation 1.92	3.76 score on a scale Standard Deviation 2.47
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm Day 3 (N=22, 20, 30, 17)	2.23 score on a scale Standard Deviation 1.51	2.50 score on a scale Standard Deviation 2.33	2.97 score on a scale Standard Deviation 2.11	3.24 score on a scale Standard Deviation 2.11
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm Day 4 (N=28, 20, 37, 23)	2.25 score on a scale Standard Deviation 1.69	1.85 score on a scale Standard Deviation 1.95	3.05 score on a scale Standard Deviation 2.17	1.91 score on a scale Standard Deviation 1.56
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm Day 6 (N=27, 20, 35, 24)	1.70 score on a scale Standard Deviation 1.59	1.40 score on a scale Standard Deviation 1.82	2.51 score on a scale Standard Deviation 2.06	1.42 score on a scale Standard Deviation 1.28
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm Day 7 (N=27, 21, 34, 22)	1.37 score on a scale Standard Deviation 1.28	1.52 score on a scale Standard Deviation 1.66	2.21 score on a scale Standard Deviation 2.24	1.23 score on a scale Standard Deviation 1.38
Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm Day 8 (N=28, 21, 35, 21)	1.21 score on a scale Standard Deviation 1.34	1.38 score on a scale Standard Deviation 1.75	1.91 score on a scale Standard Deviation 2.02	0.81 score on a scale Standard Deviation 1.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard NMB n=33 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=23 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=40 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=26 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm Day 8 (N=28, 21, 35, 21)	0.04 score on a scale Standard Deviation 0.19	0.24 score on a scale Standard Deviation 0.44	0.66 score on a scale Standard Deviation 1.49	0.14 score on a scale Standard Deviation 0.36
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm 24 hours after sugammadex dose (n=29, 22, 38, 25)	1.00 score on a scale Standard Deviation 1.71	1.18 score on a scale Standard Deviation 2.15	1.05 score on a scale Standard Deviation 1.66	1.40 score on a scale Standard Deviation 2.33
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm 48 hours after sugammadex dose (n=27, 22, 33, 23)	0.41 score on a scale Standard Deviation 0.97	0.64 score on a scale Standard Deviation 1.22	0.76 score on a scale Standard Deviation 1.23	0.96 score on a scale Standard Deviation 2.12
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm Day 3 (N=22, 20, 30, 17)	0.18 score on a scale Standard Deviation 0.50	0.80 score on a scale Standard Deviation 1.32	0.67 score on a scale Standard Deviation 1.40	0.88 score on a scale Standard Deviation 1.76
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm Day 4 (N=28, 20, 37, 23)	0.32 score on a scale Standard Deviation 1.09	0.55 score on a scale Standard Deviation 1.23	0.70 score on a scale Standard Deviation 1.60	0.61 score on a scale Standard Deviation 1.27
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm Day 5 (N=27, 21, 38, 24)	0.00 score on a scale Standard Deviation 0.00	0.43 score on a scale Standard Deviation 0.81	0.68 score on a scale Standard Deviation 1.65	0.25 score on a scale Standard Deviation 0.85
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm Day 6 (N=27, 20, 35, 24)	0.00 score on a scale Standard Deviation 0.00	0.15 score on a scale Standard Deviation 0.37	0.63 score on a scale Standard Deviation 1.55	0.21 score on a scale Standard Deviation 0.83
Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm Day 7 (N=27, 21, 34, 22)	0.00 score on a scale Standard Deviation 0.00	0.14 score on a scale Standard Deviation 0.48	0.68 score on a scale Standard Deviation 1.63	0.23 score on a scale Standard Deviation 0.69

SECONDARY outcome

Timeframe: Up to Day 8

Post operative use of pain/analgesic medication by participant through Day 8 was recorded.

Outcome measures

Outcome measures
Measure	Standard NMB n=33 Participants Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.	Deep NMB n=23 Participants Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.	Standard Insufflation Pressure n=40 Participants Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.	Low Insufflation Pressure n=26 Participants Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm Within 3 hours post surgery	31 participants using pain medication	21 participants using pain medication	37 participants using pain medication	24 participants using pain medication
Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm On Day 6, 7 or 8	19 participants using pain medication	14 participants using pain medication	25 participants using pain medication	10 participants using pain medication
Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm 3 to 24 hours post surgery	26 participants using pain medication	21 participants using pain medication	38 participants using pain medication	24 participants using pain medication
Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm 24 to 48 hours post surgery	26 participants using pain medication	22 participants using pain medication	35 participants using pain medication	23 participants using pain medication
Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm Between 48 hours and end of Day 5	27 participants using pain medication	20 participants using pain medication	29 participants using pain medication	17 participants using pain medication

Adverse Events

Standard NMB and Standard Insufflation Pressure

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Standard NMB and Low Insufflation Pressure

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Deep NMB and Standard Insufflation Pressure

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Deep NMB and Low Insufflation Pressure

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard NMB and Standard Insufflation Pressure n=33 participants at risk Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).	Standard NMB and Low Insufflation Pressure n=23 participants at risk Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).	Deep NMB and Standard Insufflation Pressure n=40 participants at risk Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).	Deep NMB and Low Insufflation Pressure n=26 participants at risk Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
Infections and infestations Necrotising fasciitis	0.00% 0/33 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/23 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/40 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	3.8% 1/26 • Number of events 1 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.
Infections and infestations Sepsis	0.00% 0/33 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/23 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/40 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	3.8% 1/26 • Number of events 1 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/33 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/23 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	2.5% 1/40 • Number of events 1 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/26 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/33 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	4.3% 1/23 • Number of events 1 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/40 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/26 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/33 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/23 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/40 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	3.8% 1/26 • Number of events 1 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.
Vascular disorders Haematoma	0.00% 0/33 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/23 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	0.00% 0/40 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.	3.8% 1/26 • Number of events 1 • Up to Day 8 Includes randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Initial public presentation of the Investigator's results will occur only together with the other sites unless permission is obtained from Sponsor. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. In case of disagreement concerning appropriateness of materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues, prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER