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Effect of depth of neuromuscular block on intraoperative surgical conditions as determined by the Leiden Surgical Rating Scale in morbidly obese patients undergoing laparoscopic bariatric surgery


- candidate number22777
- NTR NumberNTR5380
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-aug-2015
- Secondary IDsNBL52829 058.15 METC
- Public TitleEffect of depth of neuromuscular block on intraoperative surgical conditions as determined by the Leiden Surgical Rating Scale in morbidly obese patients undergoing laparoscopic bariatric surgery
- Scientific TitleEffect of depth of neuromuscular block on intraoperative surgical conditions as determined by the Leiden Surgical Rating Scale in morbidly obese patients undergoing laparoscopic bariatric surgery
- ACRONYMBLISS 3.0
- hypothesisthat deeper neuromuscular block gives less pain and better surgical conditions during laparoscopic surgery
- Healt Condition(s) or Problem(s) studiedDepth of Anaesthesia, Obesity, Pain
- Inclusion criteriaASA 1-3, 18 years or older and younger than 66 years; BMI > 34 kg/m2; ability to give informed consent; elective bariatric surgery
- Exclusion criteriaknown or suspected neuromuscular disorders impairing neuromuscular function; allergies to muscle relaxants, anesthetics or narcotics; a (family) history of malignant hyperthermia; women who are or may be pregnant or are currently breast feeding; renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h. When available, other indices will be taken into account as well such as glomerular filtration rate < 30 ml/h and proteinuria (a ratio of 30 mg albumin to 1 g of creatinine).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate30-jan-2016
- Target number of participants100
- Interventionsdeep and moderate neuromusculair block during baratric surgery
- Primary outcomebetter surgery conditions
- Secondary outcomeless post operative pain
- Timepointsper operative every 10 minutes, post operative on the PACU and the ward for 24 hours max
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. Albert Dahan
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Albert Dahan
- Sponsor/Initiator Leiden University, Medical Center Haaglanden, Nederlandse Obesitas Kliniek
- Funding
(Source(s) of Monetary or Material Support)
MSD
- Publicationshttp://www.trialsjournal.com/content/pdf/1745-6215-14-63.pdf

http://bja.oxfordjournals.org/content/112/3/498.full.pdf+html
- Brief summary
- Main changes (audit trail)
- RECORD20-aug-2015 - 11-mrt-2016


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