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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Rocuronium | Experimental | Phase 1: no neuromuscular blockade |
|
| Rocuronium (moderate NMB) | Experimental | Phase 2: moderate neuromuscular blockade (TOF 1-3) |
|
| Rocuronium (deep NMB) | Experimental | Phase 3: deep neuromuscular blockade (PTC 0-1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Rocuronium | Procedure | Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moira HD Bruintjes, Msc. | Contact | (+)31-24-3617612 | Moira.Bruintjes@radboudumc.nl | |
| Piet Krijtenburg, Drs. | Contact | (+)31-24-3619032 | Piet.Krijtenburg@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Michiel C Warlé, Dr. | Radboud University Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28575335 | Background | 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. | |
| 24240315 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 6, 2023 | |
| Unrelease | Jul 17, 2023 | |
| Release | Jul 24, 2023 | |
| Reset | Mar 7, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 6, 2023 | Jul 17, 2023 | |||
| Jul 24, 2023 |
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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).
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| Rocuronium (moderate NMB) | Drug | 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 | 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. |
|
|
| 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. |
| 37452279 | Derived | Krijtenburg 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. |
| Mar 7, 2024 |
| D011083 |
| Polycyclic Compounds |