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

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.

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum
• Intervention / Treatment: Drug: Deep neuromuscular block; Drug: Moderate neuromuscular block

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Jong Yeop Kim, Ajou University Hospital, Suwon, Gyeongki-do, Korea,

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2018
• Primary Completion (ACTUAL): July 12, 2019
• Study Completion (ACTUAL): September 19, 2019

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (ACTUAL): July 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: May 31, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: laparoscopic surgery; sugammadex; neuromuscular block; biotrauma
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: AJIRB-MED-OBS-18-115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No