Trial Outcomes & Findings for Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade. (NCT NCT02025075)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

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

Results posted on

2017-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Deep Neuromuscular Block (NMB) Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor). 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).	Moderate Neuromuscular Block (NMB) 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). 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).
Overall Study STARTED	16	21
Overall Study COMPLETED	16	19
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hemodynamic and Respiratory Variations During Laparoscopic Surgery With and Without Deep Neuromuscular Blockade.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deep Neuromuscular Block (NMB) n=16 Participants Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor). 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).	Moderate Neuromuscular Block (NMB) n=19 Participants 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). 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).	Total n=35 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 11.9 • n=5 Participants	60.7 years STANDARD_DEVIATION 9.6 • n=7 Participants	58.7 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Body Mass Index	29.7 kg/m^2 STANDARD_DEVIATION 8.1 • n=5 Participants	28.0 kg/m^2 STANDARD_DEVIATION 4.5 • n=7 Participants	28.3 kg/m^2 STANDARD_DEVIATION 7.7 • n=5 Participants
ASA Physical Status Classification I	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
ASA Physical Status Classification II	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group	Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group	Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group	Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group	Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group	Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
Regional Change in Air Content (Delta Z, %)	14.5 percent change Standard Deviation 51.6	29.0 percent change Standard Deviation 43.0	43.3 percent change Standard Deviation 39.9	-14.0 percent change Standard Deviation 40.2	19.4 percent change Standard Deviation 41.2	29.8 percent change Standard Deviation 38.2

PRIMARY outcome

Timeframe: 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

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).

Outcome measures

Outcome measures
Measure	Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group	Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group	Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group	Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group	Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group	Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
Ejection Fraction (%)	36 % fractional shortening Standard Deviation 5	34 % fractional shortening Standard Deviation 5	35 % fractional shortening Standard Deviation 4	35 % fractional shortening Standard Deviation 5	36 % fractional shortening Standard Deviation 2	37 % fractional shortening Standard Deviation 6

PRIMARY outcome

Timeframe: 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

Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.

Outcome measures

Outcome measures
Measure	Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group	Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group	Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group	Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group	Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group	Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1 n=19 Participants Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
Cerebral Oximetry (%)	74 percent cerebral saturation Standard Deviation 6	73 percent cerebral saturation Standard Deviation 5	74 percent cerebral saturation Standard Deviation 6	75 percent cerebral saturation Standard Deviation 6	75 percent cerebral saturation Standard Deviation 6	75 percent cerebral saturation Standard Deviation 7

SECONDARY outcome

Timeframe: Postoperative Day 1

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).

Outcome measures

Outcome measures
Measure	Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep n=16 Participants Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group	Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep n=19 Participants Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group	Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group	Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1 Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group	Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group	Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1 Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
Postoperative Pain	3.5 units on a scale Standard Deviation 2.0	3.1 units on a scale Standard Deviation 2.2	—	—	—	—

Adverse Events

Deep Neuromuscular Block (NMB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Moderate Neuromuscular Block (NMB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marcos Vidal Melo, MD, PhD

Massachusetts General Hospital

Phone: 617-726-8980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place