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Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

Primary Purpose

Pneumoperitoneum

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Deep neuromuscular block
Moderate neuromuscular block
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumoperitoneum focused on measuring biotrauma, laparoscopic surgery, neuromuscular block, sugammadex

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deep neuromuscular block

Moderate neuromuscular block

Arm Description

Deep neuromuscular relaxation and low pressure pneumoperitoneum

Moderate neuromuscular relaxation and standard pressure pneumoperitoneum

Outcomes

Primary Outcome Measures

Change of Cytokine
change of IL-6 (pg/ml)

Secondary Outcome Measures

Full Information

First Posted
June 14, 2018
Last Updated
May 31, 2020
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03576118
Brief Title
Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy
Official Title
The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumoperitoneum
Keywords
biotrauma, laparoscopic surgery, neuromuscular block, sugammadex

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep neuromuscular block
Arm Type
Experimental
Arm Description
Deep neuromuscular relaxation and low pressure pneumoperitoneum
Arm Title
Moderate neuromuscular block
Arm Type
Active Comparator
Arm Description
Moderate neuromuscular relaxation and standard pressure pneumoperitoneum
Intervention Type
Drug
Intervention Name(s)
Deep neuromuscular block
Other Intervention Name(s)
Deep neuromuscular block with rocumeron
Intervention Description
Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum
Intervention Type
Drug
Intervention Name(s)
Moderate neuromuscular block
Other Intervention Name(s)
Moderate neuromuscular block with rocumeron
Intervention Description
Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum
Primary Outcome Measure Information:
Title
Change of Cytokine
Description
change of IL-6 (pg/ml)
Time Frame
baseline, end of pneumoperitoneum, 24 hr after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Yeop Kim
Organizational Affiliation
Ajou University Hospital, Suwon, Gyeongki-do, Korea,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of

12. IPD Sharing Statement

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Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

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