MRI Measurement of the Effects of Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopy

Surgery Clinical Trial

— RELAX-2  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03287388
• Other study ID #: 63227.091.17
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2019
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: Radboud University
• Contact: Moira HD Bruintjes, Msc.
• Phone: (+)31-24-3617612
• Email: Moira.Bruintjes[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• scheduled for laparoscopic donor nephrectomy

• obtained informed consent

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

• American Society of Anesthesiologists (ASA) classification >2

Related Conditions & MeSH terms

• Neuromuscular Block
• Surgery

Intervention

Procedure:
• No Rocuronium
Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.

Drug:
• Rocuronium (moderate NMB)
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)
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Merck Sharp & Dohme Corp.

References & Publications (2)

Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warlé 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. — View Citation

Martini 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal working space	Skin-sacral promontory distance, measured by MRI	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	Abdominal volume	3D volume abdominal cavity, measured by MRI	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