The impact of deep versus standard muscle relaxation on intra-operative safety during laparoscopic surgery: a multicenter strategy study

Completed

Conditions: anesthesia during laparoscopic surgery i.e. upper gastrointestinal, lower gastrointestinal, urological and gynecological
anesthesia
narcosis

Registration Number: NL-OMON52488

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 508

Inclusion Criteria

• Patients scheduled for elective laparoscopic procedure with a complexity
according to the BUPA classification for case complexity: *MAJOR*, *MAJOR PLUS*
or *COMPLEX MAJOR*
• ASA class I-III
• >= 18 years of age
• Ability to give oral and written informed consent

Exclusion Criteria

• Low or intermediate complexity laparoscopic procedures (BUPA *SIMPLE* or
*INTER*)
• Known or suspected neuromuscular disorders impairing neuromuscular function
• Allergies to muscle relaxants, anesthetics or narcotics mentioned
• A (family) history of malignant hyperthermia
• Women who are or may be pregnant or are currently breast feeding
• Chronic use of any type of opioid or psychotropic drug
• Use of NSAID*s shorter than 5 days before surgery for the treatment of
chronic pain
• Indication for rapid sequence induction
• Contra-indication for sugammadex use (e.g. known sugammadex allergy or GFR<30
ml/min)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objectives:<br /><br>To study the effect of deep neuromuscular block compared to standard<br /><br>neuromuscular block on intra-operative adverse events during laparoscopic<br /><br>surgery using the CLASSIC score system;</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To study the effect of deep neuromuscular block as compared to standard<br /><br>neuromuscular block on:<br /><br>• Surgical working conditions (L-SRS)<br /><br>• 30 day post-operative complications (Clavien-Dindo,)<br /><br>• 30-day post-operative complications according to the Comprehensive<br /><br>Complication Index (https://www.assessurgery.com/)<br /><br>• 30 day unplanned readmission rates<br /><br>• Quality of recovery at post-operative day 1 and 2 after laparoscopic<br /><br>surgery.(QoR 40)<br /><br>• Quality-of-life at postoperative day 30 (SF36)</p><br>