NCT03174223

Brief Summary

Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during various abdominal and non abdominal surgeries. It is however unknown if the application of deep NMB leads to favourable outcome, such as lower rate of postoperative complications in general and surgical infections in specific and ultimately lower readmission rates. In the leiden university medical center, deep NMB is routinely applied for a variety of procedures, most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro radiologic intervention surgery, since 2014. This retrospective study intends to investigate whether the application of deep NMB for these procedures affects patient outcome and readmission rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

May 30, 2017

Last Update Submit

September 13, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Readmission

    readmission to the hospital

    30 days after surgery

Secondary Outcomes (1)

  • Cost

    30 days after surgery

Study Arms (2)

Deep neuromuscular block

patients received a continuous rocuronium dose to maintain a depth of neuromuscular block of 1-2 twitches post tetanic count

Drug: deep neuromuscular block

moderate neuromuscular block

patients received neuromuscular block aimed at \> 0 twitches train of four

Interventions

a continuous dosing of rocuronium is used to achieve neuromuscular block of 1-2 twitches post tetanic count

Deep neuromuscular block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients scheduled for laparoscopic abdominal surgery, eye surgery or neuro radiologic intervention surgery under general anesthesia

You may qualify if:

  • deep neuromuscular block
  • moderate neuromuscular block
  • general anesthesia
  • complete anesthesia chart

You may not qualify if:

  • incomplete anesthesia chart
  • missing data regarding postoperative complications or readmission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Postoperative ComplicationsSurgical Wound InfectionPneumonia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWound InfectionInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 2, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations