N/A
N=37
Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.
Intraoperative Complications · Postoperative Complications · Laparoscopy · Surgical Complications From General Anesthesia · Ventilator-Induced Lung Injury
Bottom Line
View on ClinicalTrials.gov: NCT02025075 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Regional Change in Air Content (Delta Z, %) — 14.5; 29.0; 43.3; -14.0 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rocuronium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Regional Change in Air Content (Delta Z, %) |
14.5; 29.0; 43.3; -14.0; 19.4; 29.8 | — |
| PRIMARY Ejection Fraction (%) |
36; 34; 35; 35; 36; 37 | — |
| PRIMARY Cerebral Oximetry (%) |
74; 73; 74; 75; 75; 75 | — |
| SECONDARY Postoperative Pain |
3.5; 3.1 | — |
Summary
The goal of this study is to investigate the effect of depth of neuromuscular block (NMB) on global and regional (dependent versus nondependent) respiratory mechanics during laparoscopic surgery. Furthermore, we will investigate if the level of NMB influences intraoperative hemodynamic and cerebral oxygenation.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Elective patients scheduled to undergo laparoscopic surgery with expected duration > 2h
- Physical status ASA I - III
Exclusion Criteria
- Pregnancy
- Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)
- Previous lung surgery
- History of severe chronic obstructive pulmonary disease
- Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
- Mechanical ventilation within the last 30 days
- Neuromuscular disease
- Consented for another interventional study or refusal to participate in the present study
- Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents
Data sourced from ClinicalTrials.gov (NCT02025075). 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.