Phase 4
N=128
The Laparotomy Study
Gastrointestinal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02140593 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Surgical Rating Score — 4; 4.75 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo). (Drug); Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Herlev Hospital
- Primary completion
- May 2016
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 |
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.
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). 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.