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Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03576118
Enrollment
74
Registered
2018-07-03
Start date
2018-11-05
Completion date
2019-09-19
Last updated
2020-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumoperitoneum

Keywords

biotrauma, laparoscopic surgery, neuromuscular block, sugammadex

Brief summary

The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.

Detailed description

Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines. The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).

Interventions

DRUGDeep neuromuscular block

Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum

DRUGModerate neuromuscular block

Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum

Sponsors

Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position

Exclusion criteria

* cerebrovascular disease * uncontrolled hypertension, asthma, COPD * neuromuscular disorder * patients who have had abdominal surgery * morbid obesity (body mass index \> 35 kg/m2)

Design outcomes

Primary

MeasureTime frameDescription
Change of Cytokinebaseline, end of pneumoperitoneum, 24 hr after surgerychange of IL-6 (pg/ml)

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Deep Neuromuscular Block
Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum
34
Moderate Neuromuscular Block
Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum
33
Total67

Baseline characteristics

CharacteristicModerate Neuromuscular BlockTotalDeep Neuromuscular Block
Age, Continuous44 years
STANDARD_DEVIATION 9
44 years
STANDARD_DEVIATION 8
43 years
STANDARD_DEVIATION 7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
33 Participants67 Participants34 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
33 Participants67 Participants34 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 33
other
Total, other adverse events
0 / 340 / 33
serious
Total, serious adverse events
0 / 340 / 33

Outcome results

Primary

Change of Cytokine

change of IL-6 (pg/ml)

Time frame: baseline, end of pneumoperitoneum, 24 hr after surgery

ArmMeasureGroupValue (MEAN)Dispersion
Deep Neuromuscular BlockChange of CytokineIL-6, baseline35.9 pg/mlStandard Error 16.85
Deep Neuromuscular BlockChange of CytokineIL-6, end of pneumoperitoneum31.4 pg/mlStandard Error 14.85
Deep Neuromuscular BlockChange of CytokineIL-6, 24 hr after surgery41.53 pg/mlStandard Error 16.29
Moderate Neuromuscular BlockChange of CytokineIL-6, baseline12.2 pg/mlStandard Error 8.67
Moderate Neuromuscular BlockChange of CytokineIL-6, end of pneumoperitoneum22.9 pg/mlStandard Error 9.52
Moderate Neuromuscular BlockChange of CytokineIL-6, 24 hr after surgery32.9 pg/mlStandard Error 10.29

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026