Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates

September 13, 2019 updated by: Albert Dahan, Leiden University Medical Center

Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates: A Retrospective Analysis of Patient Chart Data

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leiden, Netherlands, 2333ZA
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Deep neuromuscular block
patients received a continuous rocuronium dose to maintain a depth of neuromuscular block of 1-2 twitches post tetanic count
a continuous dosing of rocuronium is used to achieve neuromuscular block of 1-2 twitches post tetanic count
moderate neuromuscular block
patients received neuromuscular block aimed at > 0 twitches train of four

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission
Time Frame: 30 days after surgery
readmission to the hospital
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: 30 days after surgery
The total cost, including sugammadex use and readmission cost
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • p17.031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on deep neuromuscular block

Subscribe