The effects of deep muscle relaxation on the surgical conditions during laparoscopy

MRI measurement of the effects of moderate versus deep neuromuscular blockade on the abdominal working space during laparoscopic surgery in a prospective cohort study. - RELAX-2 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003623-29-NL

Enrollment

Registered

2017-12-06

Start date

2018-03-27

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

We will investigate the effect of deep neuromuscular blockade on the abdominal working space. We will include patients undergoing laparoscopic surgery, including laparoscopic donor nephrectomy, laparascopic cholecystectomy and laparoscopic colectomy.

Interventions

Trade Name: Esmeron (Rocuroniumbromide) Pharmaceutical Form: Solution for injection Trade Name: Bridion Product Name: Bridion Pharmaceutical Form: Solution for solution for infusion Trade Name: Miva

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - all adult patients (18 years or older) scheduled for laparoscopic donor nephrectomy, laparoscopic cholecystectomy or laparoscopic colectomy - obtained informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: • Unable to provide informed consent • known or suspect allergy to mivacurium, rocuronium or sugammadex • neuromuscular disease • indication for rapid sequence induction • Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants, epilepsy) • BMI>30 kg/m2 • ASA-score >2

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To study the effect of moderate NMB versus no NMB on the abdominal working space (distance from skin to sacral promontory and 3D volume) during laparoscopy with standard pressure pneumoperitoneum.;Main Objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) and the abdominal working space (distance from skin to sacral promontory and 3D volume) during laparoscopy with standard pressure pneumoperitoneum.;Primary end point(s): The abdominal working space space measured by MRI: Skin - sacral promontory distance;Timepoint(s) of evaluation of this end point: Following induction of general anesthesia and creation of pneumoperitoneum, each patiënt will undergo a MRI scan in 3 phases (total duration 30 minutes) - phase 1: no NMB (first scan) - phase 2: moderate NMB (second scan) - phase 3: deep NMB (third scan) After completion of the third scan the laparoscopic procedure will be continued.	—

Measure

Time frame

Secondary Objective: To study the effect of moderate NMB versus no NMB on the abdominal working space (distance from skin to sacral promontory and 3D volume) during laparoscopy with standard pressure pneumoperitoneum.;Main Objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) and the abdominal working space (distance from skin to sacral promontory and 3D volume) during laparoscopy with standard pressure pneumoperitoneum.;Primary end point(s): The abdominal working space space measured by MRI: Skin - sacral promontory distance;Timepoint(s) of evaluation of this end point: Following induction of general anesthesia and creation of pneumoperitoneum, each patiënt will undergo a MRI scan in 3 phases (total duration 30 minutes) - phase 1: no NMB (first scan) - phase 2: moderate NMB (second scan) - phase 3: deep NMB (third scan) After completion of the third scan the laparoscopic procedure will be continued.

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Secondary

Measure	Time frame
Secondary end point(s): The abdominal working space space measured by MRI: 3D volume of the abdominal cavity;Timepoint(s) of evaluation of this end point: Following introduction of general anesthesia and creation of pneumoperitoneum, each patiënt will undergo a MRI scan in 3 phases (total duration 30 minutes) - phase 1: no NMB (first scan) - phase 2: moderate NMB (second scan) - phase 3: deep NMB (third scan) After completion of the third scan the laparoscopic procedure will be continued.	—

Measure

Time frame

Secondary end point(s): The abdominal working space space measured by MRI: 3D volume of the abdominal cavity;Timepoint(s) of evaluation of this end point: Following introduction of general anesthesia and creation of pneumoperitoneum, each patiënt will undergo a MRI scan in 3 phases (total duration 30 minutes) - phase 1: no NMB (first scan) - phase 2: moderate NMB (second scan) - phase 3: deep NMB (third scan) After completion of the third scan the laparoscopic procedure will be continued.

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Countries

Netherlands

Contacts

Public ContactRELAX-2 information

Radboudumc

Moira.Bruintjes@radboudumc.nl+31243617612

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026