Influence of Deep Versus Moderate Neuromuscular Blockade... | NCT03174223

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

NCT03174223

Sponsor

Leiden University Medical Center

Status

Completed

Last Update Posted

Sep 17, 2019Actual

Enrollment

460Actual

Phase

Not provided

Conditions

Postoperative Complications
Postoperative Wound Infection
Pneumonia

Interventions

deep neuromuscular block

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2017Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Jul 1, 2018Actual

First Submitted Date

May 30, 2017

First Submission Date that Met QC Criteria

Jun 1, 2017

First Posted Date

Jun 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2019

Last Update Posted Date

Sep 17, 2019Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

460Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
deep neuromuscular block	Drug	a continuous dosing of rocuronium is used to achieve neuromuscular block of 1-2 twitches post tetanic count	Deep neuromuscular block

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University Medical Center		Leiden		2333ZA	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D011183	Postoperative Complications
D013530	Surgical Wound Infection
D011014	Pneumonia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014946	Wound Infection
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided