Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

Pneumoperitoneum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03576118
• Other study ID #: AJIRB-MED-OBS-18-115
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: September 19, 2019

Study information

• Verified date: May 2020
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 19, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pneumoperitoneum

Intervention

Drug:
• Deep neuromuscular block
Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum
• Moderate neuromuscular block
Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Cytokine	change of IL-6 (pg/ml)	baseline, end of pneumoperitoneum, 24 hr after surgery