An interventional study of Rocuronium in Intraoperative Complications, Postoperative Complications and Laparoscopy, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Basic science
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.
81 studies on the registry are indexed under Intraoperative Complications; 18 are open to participants now.
This study's enrollment of 37 is below the median of 66 across 41 interventional studies indexed under Intraoperative Complications.
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Exclusion Criteria:
Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).
Drug: Rocuronium
Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).
Drug: Rocuronium
Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).
Also known as: Zemuron
Regional Change in Air Content (Delta Z, %)
We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6). Percent change was calculated using electrical impedance measurements obtained at time T0 as reference.
Time frame: BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum
Ejection Fraction (%)
To assess cardiac performance, transthoracic echocardiography will be used. Ejection fraction was measured as fractional shortening (FS). FS is the fraction of any diastolic dimension that is lost in systole. FS = 100\*(LVEDD - LVESD) / LVEDD, LVEDD = LV end-diastolic dimension (mm); LVESD = LV end-systolic dimension (mm).
Time frame: BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum
Cerebral Oximetry (%)
Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.
Time frame: BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum
Postoperative Pain
The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as incisional pain using VAS (0 = no pain; 100 = worst possible pain).
Time frame: Postoperative Day 1
| Milestone | Deep Neuromuscular Block (NMB) | Moderate Neuromuscular Block (NMB) |
|---|---|---|
| Started | 16 | 21 |
| Completed | 16 | 19 |
| Not completed | 0 | 2 |
We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6). Percent change was calculated using electrical impedance measurements obtained at time T0 as reference.
| percent change | Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep | Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep | Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep | Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1 | Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 | Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1 |
|---|---|---|---|---|---|---|
| Regional Change in Air Content (Delta Z, %) | 14.5 ± 51.6 | 29.0 ± 43.0 | 43.3 ± 39.9 | -14.0 ± 40.2 | 19.4 ± 41.2 | 29.8 ± 38.2 |
To assess cardiac performance, transthoracic echocardiography will be used. Ejection fraction was measured as fractional shortening (FS). FS is the fraction of any diastolic dimension that is lost in systole. FS = 100\*(LVEDD - LVESD) / LVEDD, LVEDD = LV end-diastolic dimension (mm); LVESD = LV end-systolic dimension (mm).
| % fractional shortening | Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep | Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep | Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep | Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1 | Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 | Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1 |
|---|---|---|---|---|---|---|
| Ejection Fraction (%) | 36 ± 5 | 34 ± 5 | 35 ± 4 | 35 ± 5 | 36 ± 2 | 37 ± 6 |
Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.
| percent cerebral saturation | Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep | Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep | Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep | Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1 | Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 | Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1 |
|---|---|---|---|---|---|---|
| Cerebral Oximetry (%) | 74 ± 6 | 73 ± 5 | 74 ± 6 | 75 ± 6 | 75 ± 6 | 75 ± 7 |
The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as incisional pain using VAS (0 = no pain; 100 = worst possible pain).
| units on a scale | Deep Neuromuscular Block (NMB) | Moderate Neuromuscular Block (NMB) |
|---|---|---|
| Postoperative Pain | 3.5 ± 2.0 | 3.1 ± 2.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Deep Neuromuscular Block (NMB) | — | 0/16 (0%) | 0/16 (0%) |
| Moderate Neuromuscular Block (NMB) | — | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Deep Neuromuscular Block (NMB) | Moderate Neuromuscular Block (NMB) | Total |
|---|---|---|---|
| Mean | 56.6 ± 11.9 | 60.7 ± 9.6 | 58.7 ± 10.8 |
| Sex: Female, Male(Participants) | Deep Neuromuscular Block (NMB) | Moderate Neuromuscular Block (NMB) | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 11 | 15 | 26 |
| Region of Enrollment(Participants) | Deep Neuromuscular Block (NMB) | Moderate Neuromuscular Block (NMB) | Total |
|---|---|---|---|
| United States | 16 | 19 | 35 |
| Body Mass Index(kg/m^2) | Deep Neuromuscular Block (NMB) | Moderate Neuromuscular Block (NMB) | Total |
|---|---|---|---|
| Mean | 29.7 ± 8.1 | 28.0 ± 4.5 | 28.3 ± 7.7 |
| ASA Physical Status Classification(Participants) | Deep Neuromuscular Block (NMB) | Moderate Neuromuscular Block (NMB) | Total |
|---|---|---|---|
| I | 1 | 2 | 3 |
| II | 15 | 17 | 32 |
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Studies of the drug tested here: Rocuronium
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