Neuromuscular BlockRELAX-2NCT03287388
MRI Measurement of the Effects of Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopy
A study testing No Rocuronium, Rocuronium (moderate NMB) and Rocuronium (deep NMB) in people with Neuromuscular Block and Surgery, run by Radboud University Medical Center.
Trial summary
During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum. Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the quality of the surgical space conditions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Block, Surgery
- What is being tested?
- No Rocuronium, Rocuronium (moderate NMB) and Rocuronium (deep NMB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for laparoscopic donor nephrectomy
- obtained informed consent
Who cannot join
- 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
- American Society of Anesthesiologists (ASA) classification >2
Trial locations and contacts
No sites are listed yet.
About this study
Official title: MRI Measurement of the Effects of Moderate Versus Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopic Surgery in a Prospective Cohort Study.
During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum. Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the quality of the surgical space conditions during laparoscopy (1), showed that compared to moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2).
In this prospective cohort study, we will assess the influence of deep neuromuscular blockade on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for laparoscopic donor nephrectomy
Read the detailed description
Objective: To establish the influence of deep neuromuscular blockade (NMB) on the abdominal working space during laparoscopy.
Study design: A single center prospective cohort study
Study population: 10 adult patients (18 years or older), equally distributed by gender, scheduled for laparoscopic donor nephrectomy
Study procedures:
Induction of general anesthesia followed by intubation and creation of a pneumoperitoneum (12 mmHg).
Each patient will have a MRI scan during 3 stages:
Phase 1: No neuromuscular blockade (TOF ratio 1) Phase 2: moderate neuromuscular blockade(TOF 1-3). Phase 3: deep neuromuscular blockade (PTC 0-1)
Primary outcome:
The abdominal space measured by MRI: Skin - sacral promontory distance
Secondary outcome:
3D volume measurement of the abdominal cavity by MRI.
- Conditions
- Neuromuscular Block, Surgery
- Being tested
- No Rocuronium, Rocuronium (moderate NMB), Rocuronium (deep NMB)
- Keywords
- Laparoscopic surgery, Abdominal working space, Moderate neuromuscular blockade, Deep neuromuscular blockade, MRI measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No RocuroniumProcedure or surgery
Also called No neuromuscular blockade
Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.
Rocuronium (moderate NMB)Drug
Also called Moderate neuromuscular blockade (Rocuronium)
Phase 2: Rocuronium will be titrated to a moderate NMB (TOF 1-3), monitored by TOF-watch. When an adequate moderate NMB is achieved, the patient will undergo a second MRI-abdomen.
Rocuronium (deep NMB)Drug
Also called Deep neuromuscular blockade (Rocuronium)
Phase 3: The patient receives a bolus of 1.2 mg/kg rocuronium (adjusted to ideal body weight), to assure a deep or intense NMB (PTC 0-1). Then the patient will undergo the final, third MRI scan of the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| No Rocuronium | Experimental | Phase 1: no neuromuscular blockade Receives: Procedure: No Rocuronium |
| Rocuronium (moderate NMB) | Experimental | Phase 2: moderate neuromuscular blockade (TOF 1-3) Receives: Drug: Rocuronium (moderate NMB) |
| Rocuronium (deep NMB) | Experimental | Phase 3: deep neuromuscular blockade (PTC 0-1) Receives: Drug: Rocuronium (deep NMB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal working space
Skin-sacral promontory distance, measured by MRI
Measured: 3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
Secondary outcomes (1)
Abdominal volume
3D volume abdominal cavity, measured by MRI
Measured: 3 times (phase 1 no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study startMay 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Each patient wil serve as its own control: Each patient will start without neuromuscular blockade (phase 1), followed by moderate neuromuscular blockade (phase 2) and deep neuromuscular blockade (phase 3).
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Michiel C Warlé, Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287388
- Sponsor's protocol ID
- 63227.091.17
- Acronym
- RELAX-2
- Status last verified
- Apr 2018
- First submitted
- 4 Sep 2017
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warle MC. Deep neuromuscular block to optimize surgical space conditions during laparoscopic surgery: a systematic review and meta-analysis. Br J Anaesth. 2017 Jun 1;118(6):834-842. doi: 10.1093/bja/aex116.
PubMed 28575335Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
PubMed 24240315Krijtenburg P, Bruintjes MHD, Futterer JJ, van de Steeg G, d'Ancona F, Scheffer GJ, Keijzer C, Warle MC. MRI measurement of the effects of moderate and deep neuromuscular blockade on the abdominal working space during laparoscopic surgery, a clinical study. BMC Anesthesiol. 2023 Jul 14;23(1):238. doi: 10.1186/s12871-023-02201-1.
PubMed 37452279
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Measurement of the Effects of Moderate Versus Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopic Surgery in a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03287388
- Acronym / sponsor ID
- RELAX-2 / 63227.091.17
- Conditions
- Neuromuscular Block, Surgery
- Keywords
- Laparoscopic surgery, Abdominal working space, Moderate neuromuscular blockade, Deep neuromuscular blockade, MRI measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum. Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the quality of the surgical space conditions during laparoscopy (1), showed that compared to moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2).
In this prospective cohort study, we will assess the influence of deep neuromuscular blockade on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for laparoscopic donor nephrectomy
Detailed description
Objective: To establish the influence of deep neuromuscular blockade (NMB) on the abdominal working space during laparoscopy.
Study design: A single center prospective cohort study
Study population: 10 adult patients (18 years or older), equally distributed by gender, scheduled for laparoscopic donor nephrectomy
Study procedures:
Induction of general anesthesia followed by intubation and creation of a pneumoperitoneum (12 mmHg).
Each patient will have a MRI scan during 3 stages:
Phase 1: No neuromuscular blockade (TOF ratio 1) Phase 2: moderate neuromuscular blockade(TOF 1-3). Phase 3: deep neuromuscular blockade (PTC 0-1)
Primary outcome:
The abdominal space measured by MRI: Skin - sacral promontory distance
Secondary outcome:
3D volume measurement of the abdominal cavity by MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each patient wil serve as its own control: Each patient will start without neuromuscular blockade (phase 1), followed by moderate neuromuscular blockade (phase 2) and deep neuromuscular blockade (phase 3).
| Arm | Type | Receives |
|---|---|---|
| No Rocuronium | Experimental | Procedure: No RocuroniumPhase 1: no neuromuscular blockade |
| Rocuronium (moderate NMB) | Experimental | Drug: Rocuronium (moderate NMB)Phase 2: moderate neuromuscular blockade (TOF 1-3) |
| Rocuronium (deep NMB) | Experimental | Drug: Rocuronium (deep NMB)Phase 3: deep neuromuscular blockade (PTC 0-1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for laparoscopic donor nephrectomy
- obtained informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No RocuroniumAlso: No neuromuscular blockadePhase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1. | Procedure or surgery | No Rocuronium |
| Rocuronium (moderate NMB)Also: Moderate neuromuscular blockade (Rocuronium)Phase 2: Rocuronium will be titrated to a moderate NMB (TOF 1-3), monitored by TOF-watch. When an adequate moderate NMB is achieved, the patient will undergo a second MRI-abdomen. | Drug | Rocuronium (moderate NMB) |
| Rocuronium (deep NMB)Also: Deep neuromuscular blockade (Rocuronium)Phase 3: The patient receives a bolus of 1.2 mg/kg rocuronium (adjusted to ideal body weight), to assure a deep or intense NMB (PTC 0-1). Then the patient will undergo the final, third MRI scan of the abdomen. | Drug | Rocuronium (deep NMB) |
Primary outcome
Abdominal working space
Time frame: 3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
Skin-sacral promontory distance, measured by MRI
1 secondary outcome
Abdominal volume
Time frame: 3 times (phase 1 no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Background: PubMed 28575335Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warle MC. Deep neuromuscular block to optimize surgical space conditions during laparoscopic surgery: a systematic review and meta-analysis. Br J Anaesth. 2017 Jun 1;118(6):834-842. doi: 10.1093/bja/aex116.
- Background: PubMed 24240315Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
- Derived from this study: PubMed 37452279Krijtenburg P, Bruintjes MHD, Futterer JJ, van de Steeg G, d'Ancona F, Scheffer GJ, Keijzer C, Warle MC. MRI measurement of the effects of moderate and deep neuromuscular blockade on the abdominal working space during laparoscopic surgery, a clinical study. BMC Anesthesiol. 2023 Jul 14;23(1):238. doi: 10.1186/s12871-023-02201-1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michiel C Warlé, Dr. principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing No Rocuronium, Rocuronium (moderate NMB) and Rocuronium (deep NMB) in people with Neuromuscular Block and Surgery, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moira HD Bruintjes, Msc. ((+)31-24-3617612, Moira.Bruintjes@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal working space (time frame: 3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03287388, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.