Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

• Sponsor: Ajou University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03576118
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumoperitoneum	Drug: Deep neuromuscular block; Drug: Moderate neuromuscular block	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy
• Actual Study Start Date: Nov 5, 2018
• Actual Primary Completion Date: Jul 12, 2019
• Actual Study Completion Date: Sep 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deep neuromuscular block Deep neuromuscular relaxation and low pressure pneumoperitoneum	Drug: Deep neuromuscular block; Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum; Other Names: Deep neuromuscular block with rocumeron
Active Comparator: Moderate neuromuscular block Moderate neuromuscular relaxation and standard pressure pneumoperitoneum	Drug: Moderate neuromuscular block; Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum; Other Names: Moderate neuromuscular block with rocumeron

Outcome Measures

Primary Outcome Measures

1. Change of Cytokine [baseline, end of pneumoperitoneum, 24 hr after surgery]

   change of IL-6 (pg/ml)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon	Gyeonggi-do	Korea, Republic of	16499

Sponsors and Collaborators

• Ajou University School of Medicine

Investigators

• Principal Investigator: Jong Yeop Kim, Ajou University Hospital, Suwon, Gyeongki-do, Korea,

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2019

More Information

Publications

None provided.

• Responsible Party: Jong Yeop Kim, Professor, Ajou University School of Medicine
• ClinicalTrials.gov Identifier: NCT03576118
• Other Study ID Numbers: AJIRB-MED-OBS-18-115
• First Posted: Jul 3, 2018
• Last Update Posted: Jun 11, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jong Yeop Kim, Professor, Ajou University School of Medicine: biotrauma; laparoscopic surgery; neuromuscular block; sugammadex
• Additional relevant MeSH terms: Pneumoperitoneum

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Deep Neuromuscular Block	Moderate Neuromuscular Block	Total
Arm/Group Description	Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum	Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum	Total of all reporting groups
Overall Participants	34	33	67
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43 (7)	44 (9)	44 (8)
Sex: Female, Male (Count of Participants)
Female	34 100%	33 100%	67 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	34 100%	33 100%	67 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change of Cytokine
Description	change of IL-6 (pg/ml)
Time Frame	baseline, end of pneumoperitoneum, 24 hr after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Deep Neuromuscular Block	Moderate Neuromuscular Block
Arm/Group Description	Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum	Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum
Measure Participants	34	33
IL-6, baseline	35.9 (16.85)	12.2 (8.67)
IL-6, end of pneumoperitoneum	31.4 (14.85)	22.9 (9.52)
IL-6, 24 hr after surgery	41.53 (16.29)	32.9 (10.29)

Adverse Events

Time Frame	baseline, end of pneumoperitoneum, 24 hr after surgery
Arm/Group Title	Deep Neuromuscular Block		Moderate Neuromuscular Block
Arm/Group Description	Deep neuromuscular relaxation and low pressure pneumoperitoneum Deep neuromuscular block: Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum		Moderate neuromuscular relaxation and standard pressure pneumoperitoneum Moderate neuromuscular block: Moderate neuromuscular block using moderate dose rocuronium and 12 mmHg pneumoperitoneum
All Cause Mortality
	Deep Neuromuscular Block		Moderate Neuromuscular Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)
Serious Adverse Events
	Deep Neuromuscular Block		Moderate Neuromuscular Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Deep Neuromuscular Block		Moderate Neuromuscular Block
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.