To study the effect of deep neuromuscular block compared to standard neuromuscular block on intra-operative adverse events during laparoscopic surgery using the CLASSIC score system.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
anesthesia during laparoscopic surgery i.e. upper gastrointestinal, lower gastrointestinal, urological and gynecological
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objectives:
To study the effect of deep neuromuscular block compared to standard
neuromuscular block on intra-operative adverse events during laparoscopic
surgery using the CLASSIC score system;
Secondary outcome
To study the effect of deep neuromuscular block as compared to standard
neuromuscular block on:
• Surgical working conditions (L-SRS)
• 30 day post-operative complications (Clavien-Dindo,)
• 30-day post-operative complications according to the Comprehensive
Complication Index (https://www.assessurgery.com/)
• 30 day unplanned readmission rates
• Quality of recovery at post-operative day 1 and 2 after laparoscopic
surgery.(QoR 40)
• Quality-of-life at postoperative day 30 (SF36)
Background summary
Muscle relaxants are routinely applied during anesthesia to facilitate
endotracheal intubation and to improve surgical working conditions. Several
investigations have shown that a deep neuromuscular block (NMB) (post tetanic
count (PTC) 1-2 twitches) improves the surgical working conditions over a
moderate NMB (TOF count 1-3 twitches) and effectively precludes sudden
deterioration of the surgical field. However, whether the improvement of
surgical working conditions translates into less intra- and postoperative
complications remains uncertain. A recent retrospective analysis of
neuromuscular management during laparoscopic retroperitoneal surgery showed a
reduced rate of unplanned 30 day readmissions when a deep NMB over a moderate
NMB was applied (3.8% vs. 12.7%).In addition, a pooled analysis of 4 randomized
controlled trials comparing different levels of intra-abdominal pressure and
neuromuscular blockade during laparoscopic donor nephrectomy, showed a
significant reduction in the incidence of intra-operative surgical
complications from 12.6% with moderate NMB to 4.8% with deep NMB.
These previous observations were made in small prospective or retrospective
studies. There is a need to confirm these outcome data prospectively, in a
larger prospective trial for a variety of surgical procedures. We therefore
propose a multi-center, randomized controlled trial, to study the effect of a
deep NMB (PTC 1-2 twitches) versus standard NMB (single induction dose
rocuronium) in a variety of laparoscopic surgical procedures on the incidence
of intraoperative adverse events and postoperative outcome data.
Study objective
To study the effect of deep neuromuscular block compared to standard
neuromuscular block on intra-operative adverse events during laparoscopic
surgery using the CLASSIC score system.
Study design
The EURO Relax is an investigator initiated, multi-center, randomized
controlled trial in patients undergoing laparoscopic abdominal surgery. A
multicenter design was chosen to optimize generalizability and to guarantee
patient enrollment within 14-15 months. Patients undergoing laparoscopic
surgery in different fields of surgery will be randomized 1:1 in blocks of 2
and 4 to the deep or standard neuromuscular block group. Randomization will be
stratified per center and BUPA category (MAJOR, MAJOR PLUS or COMPLEX MAJOR).
Study burden and risks
Both strategy's of neuromuscular block are part of the routine clinical care in
anesthesia. No additional risk are therefore expect within the study
population. Patients are only required to fill in questionnaires at 4 different
moments.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
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)
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70081.058.19 |