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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52488

Enrollment

508

Registered

2019-10-08

Start date

2020-02-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Netherlands

Outcome results