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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03174223
Other study ID # p17.031
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date July 1, 2018

Study information

Verified date September 2019
Source Leiden University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 460
Est. completion date July 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Netherlands Leiden University Medical Center Leiden

Sponsors (2)

Lead Sponsor Collaborator
Leiden University Medical Center Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmission readmission to the hospital 30 days after surgery
Secondary Cost The total cost, including sugammadex use and readmission cost 30 days after surgery
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