|- candidate number||25696|
|- NTR Number||NTR6165|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-dec-2016|
|- Secondary IDs||G16.041 METC LUMC|
|- Public Title||A study on the effect of deep neuromuscular block on perioperative parameters|
|- Scientific Title||A retrospective observational study on the perioperative parameters of adult patients undergoing deep neuromuscular block surgery at Leiden University Medical Center|
|- hypothesis||Deep neuromuscular block has advantages over a moderate neuromuscular block in term of outcome (pain, respiration) but has otherwise no effects on the patient|
|- Healt Condition(s) or Problem(s) studied||General anesthesia|
|- Inclusion criteria||-Patients that received a deep neuromuscular block in the period July 2015-december 2016 |
-urological, surgical, ophthalmologic and neurosurgical procedures.
-age 18 years or older
-Patients matched for sex and procedure that received general anesthesia under moderate block (historical cohort)
|- Exclusion criteria||-Age < 18 years.|
-Procedures other than urology, surgery, ophthalmology or neurosurgery.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jan-2017|
|- planned closingdate||1-jan-2018|
|- Target number of participants||230|
|- Interventions||Observational retrospective data retrieval from the patient data monitoring system.|
|- Primary outcome||Drug dose, blood pressure, heart rate, bispectral index, postoperative pain, complication rate, re-admission.
|- Secondary outcome||None|
|- Timepoints||Retrospective data retrieval, no time points specified.|
|- Trial web site|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Albert Dahan|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Albert Dahan|
|- Sponsor/Initiator ||Leiden University|
(Source(s) of Monetary or Material Support)
|- Brief summary||Deep Neuromuscular Block (NMB) is associated with improved ratings of the quality of the surgical field in a number of surgical procedures including urological and gynecological surgeries.1 Recent data from the BLISS 3 trial additionally suggests that a deep NMB is associated with improved postoperative outcomes in terms of reduced pain in the PACU and on the ward.2 Consequently, the number of patients that receives a deep NMB has dramatically increased in our hospital. For example, currently all retroperitoneal surgeries in urology (nephrectomies, prostatectomies, lymph node removal), open eye surgeries and intracerebral vascular surgeries (eg., intracranial thrombectomies) are performed under deep NMB according to strict guidelines (ie. TOF zero, PTC 1-5).
Evidence demonstrating the benefit of a deep NMB or the absence of such benefit on outcomes apart from the subjective impressions of the surgeon is lacking. Additionally, there are no real-world data available of the deep NMB as all of the above mentioned benefits are obtained from well-controlled clinical trials. Hence, the current project aims to collect the characteristics of the deep NMB and expand the data collection to the post-anesthesia care unit and the ward. One example of a data gap is that we remain uniformed whether patients following a deep NMB experience less pain. This study aims to address the data gap on deep NMB by retrieval of objective data from LUMC database in patients undergoing elective surgery under deep NMB.
The main objective of the current retrospective analysis is to examine perioperative parameters in deep NMB. Historical control data of non-deep NMB cases will be examined for comparison.
|- Main changes (audit trail)|
|- RECORD||27-dec-2016 - 12-feb-2017|