NCT03576118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 11, 2020

Completed
Last Updated

June 11, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

June 14, 2018

Results QC Date

March 28, 2020

Last Update Submit

May 31, 2020

Conditions

Pneumoperitoneum

Keywords

biotraumalaparoscopic surgeryneuromuscular blocksugammadex

Outcome Measures

Primary Outcomes (1)

  • Change of Cytokine

    change of IL-6 (pg/ml)

    baseline, end of pneumoperitoneum, 24 hr after surgery

Study Arms (2)

Deep neuromuscular block

EXPERIMENTAL

Deep neuromuscular relaxation and low pressure pneumoperitoneum

Drug: Deep neuromuscular block

Moderate neuromuscular block

ACTIVE COMPARATOR

Moderate neuromuscular relaxation and standard pressure pneumoperitoneum

Drug: Moderate neuromuscular block

Interventions

Deep neuromuscular blockDRUG

Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum

Also known as: Deep neuromuscular block with rocumeron
Deep neuromuscular block
Moderate neuromuscular blockDRUG

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

Also known as: Moderate neuromuscular block with rocumeron
Moderate neuromuscular block

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position

You may not qualify if:

  • cerebrovascular disease
  • uncontrolled hypertension, asthma, COPD
  • neuromuscular disorder
  • patients who have had abdominal surgery
  • morbid obesity (body mass index \> 35 kg/m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Results Point of Contact

Title
Dr. Jong Yeop Kim
Organization
Ajou University Hospital
kjyeop@ajou.ac.kr
+82312195574

Study Officials

  • Jong Yeop Kim

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2018

First Posted

July 3, 2018

Study Start

November 5, 2018

Primary Completion

July 12, 2019

Study Completion

September 19, 2019

Last Updated

June 11, 2020

Results First Posted

June 11, 2020

Record last verified: 2020-05

Locations

KR(1)