Phase 4
Completed N=42
Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum.
Muscle Relaxation
Source: ClinicalTrials.gov NCT01930747 ↗
Enrolled (actual)
42
Serious AEs
2.4%
Results posted
May 2019
Primary outcomePrimary: Effect of Anesthetics on the Pressure at Zero Volume (PV0) Measured During Insufflation of the Abdomen — 5.7; 8.29; 6.58 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
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 | — |
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. Informational only — not medical advice.