Phase 4
Completed N=128
The Laparotomy Study
Source: ClinicalTrials.gov NCT02140593 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Surgical Rating Score — 4; 4.75 units on a scale — p=<0.05
◆ Published Evidence
Established
35citations · ~4 / year
Influence of deep neuromuscular block on the surgeonś assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex.
Summary
The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade.
The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.
Linked Publications (2)
-
Influence of deep neuromuscular block on the surgeonś assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex.
-
Neuromuscular blockade for improvement of surgical conditions during laparotomy: protocol for a randomised study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Rating Score |
4; 4.75 | <0.05 sig |
| SECONDARY The Surgical Rating Score During Fascial Closure |
4; 5 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Patients > 18 years old
- Elective open upper abdominal surgery
- Can read and understand Danish
- Informed consent
Exclusion Criteria
- Known allergy to rocuronium or sugammadex
- Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or hemodialysis
- Neuromuscular disease that may interfere with neuromuscular data
- Abdominal mesh with size larger than 5*5 cm
- Lactating or pregnant
Data sourced from ClinicalTrials.gov (NCT02140593) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.