Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

NCT ID: NCT03576118

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2019-09-19

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).

Conditions

Pneumoperitoneum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Deep neuromuscular block

Deep neuromuscular relaxation and low pressure pneumoperitoneum

Group Type: EXPERIMENTAL

Deep neuromuscular block

Intervention Type: DRUG

Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum

Moderate neuromuscular block

Moderate neuromuscular relaxation and standard pressure pneumoperitoneum

Group Type: ACTIVE_COMPARATOR

Moderate neuromuscular block

Intervention Type: DRUG

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

Interventions

Deep neuromuscular block

Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum

Intervention Type: DRUG

Moderate neuromuscular block

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

Intervention Type: DRUG

Other Intervention Names

Deep neuromuscular block with rocumeron; Moderate neuromuscular block with rocumeron

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jong Yeop Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jong Yeop Kim

Role: PRINCIPAL_INVESTIGATOR

Ajou University Hospital, Suwon, Gyeongki-do, Korea,

Locations

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AJIRB-MED-OBS-18-115

Identifier Type: -

Identifier Source: org_study_id