Phase 4
N=42
Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum.
Muscle Relaxation
Bottom Line
View on ClinicalTrials.gov: NCT01930747 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
May 2019
Primary outcome: Primary: Effect of Anesthetics on the Pressure at Zero Volume (PV0) Measured During Insufflation of the Abdomen — 5.7; 8.29; 6.58 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rocuronium (Drug); Sevoflurane (Drug); remifentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AZ Sint-Jan AV
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Anesthetics on the Pressure at Zero Volume (PV0) Measured During Insufflation of the Abdomen |
5.7; 8.29; 6.58 | — |
| PRIMARY Effect of Anesthetics on the Abdominal Elastance (E) Measured During Insufflation of the Abdomen by |
2.53; 2.71; 2.5 | — |
| SECONDARY Adverse Events Difference Between the Three Groups |
0; 0; 0 | — |
Summary
The objective of this study is to compare the value of deep neuromuscular block (NMB) (using rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 minimum alveolar concentration (MAC) inhalation (using sevoflurane) for the surgeon.
The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points allow to calculate the abdominal compliance and the pressure at zero volume (PV0).
Eligibility Criteria
Inclusion Criteria
- Laparoscopic bariatric surgery in a patient older than 18 years of age without previous laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric bypass
Exclusion Criteria
- Allergies or contraindications to the use of one or more of the following drugs: propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane
- History of a laparotomy
- Emergency laparoscopy
Data sourced from ClinicalTrials.gov (NCT01930747). 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.