Trial Outcomes & Findings for Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy (NCT NCT03576118)

NCT ID: NCT03576118

Last Updated: 2020-06-11

Results Overview

change of IL-6 (pg/ml)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: baseline, end of pneumoperitoneum, 24 hr after surgery
• Results posted on: 2020-06-11

Participant Flow

Participant milestones

Measure	Deep Neuromuscular Block Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum	Moderate Neuromuscular Block Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum
Overall Study STARTED	37	37
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

Baseline characteristics by cohort

Measure	Deep Neuromuscular Block n=34 Participants Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum	Moderate Neuromuscular Block n=33 Participants Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum	Total n=67 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 7 • n=5 Participants	44 years STANDARD_DEVIATION 9 • n=7 Participants	44 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, end of pneumoperitoneum, 24 hr after surgery

change of IL-6 (pg/ml)

Outcome measures

Measure	Deep Neuromuscular Block n=34 Participants Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum	Moderate Neuromuscular Block n=33 Participants Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum
Change of Cytokine IL-6, baseline	35.9 pg/ml Standard Error 16.85	12.2 pg/ml Standard Error 8.67
Change of Cytokine IL-6, end of pneumoperitoneum	31.4 pg/ml Standard Error 14.85	22.9 pg/ml Standard Error 9.52
Change of Cytokine IL-6, 24 hr after surgery	41.53 pg/ml Standard Error 16.29	32.9 pg/ml Standard Error 10.29

Adverse Events

Deep Neuromuscular Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate Neuromuscular Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jong Yeop Kim

Ajou University Hospital

Phone: +82312195574

Email: kjyeop@ajou.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place