Abstract
INTRODUCTION: Laparoscopic herniotomy is the preferred technique for some ventral hernias. Several factors may influence the surgical conditions, one being the depth of neuromuscular blockade (NMB) applied. We hypothesised that deep neuromuscular blockade defined as a post-tetanic count below eight would provide a better surgical workspace. METHOD: This is an investigator-initiated, assessor- and patient- blinded randomised cross-over study. A total of 34 patients with planned laparoscopic umbilical, incisional and linea alba herniotomy are studied. Patients will be randomised to receive deep NMB followed by no NMB, or no NMB followed by deep NMB. Our primary outcome is improvement of the surgical workspace (rated on a five-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Secondary outcomes include, among others, surgeon’s rating of surgical conditions during suturing, duration of surgery and duration of the suturing of the hernia. CONCLUSION: This randomised cross-over study investigates a potential effect on the surgical workspace in laparoscopic ventral herniotomy using deep NMB compared with no NMB. The study may provide knowledge relevant to other laparoscopic techniques. FUNDING: The study is funded by a research grant from the Investigator Initiated Studies Program of Merck Sharp & Dohme Corp. TRIAL REGISTRATION: NCT02247466.
| Original language | English |
|---|---|
| Article number | A5120 |
| Journal | Danish Medical Journal |
| Volume | 62 |
| Issue number | 8 |
| Pages (from-to) | 1-6 |
| Number of pages | 6 |
| ISSN | 2245-1919 |
| Publication status | Published - 1 Aug 2015 |
Keywords
- Adult
- Clinical Protocols
- Cross-Over Studies
- Double-Blind Method
- Hernia, Ventral
- Herniorrhaphy
- Humans
- Intraoperative Period
- Laparoscopy
- Monitoring, Intraoperative
- Neuromuscular Blockade
- Operative Time
- Suture Techniques
- Treatment Outcome