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

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ClinicalTrials.gov Identifier: NCT02025075
Recruitment Status : Completed
First Posted : December 31, 2013
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Marcos Vidal Melo, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Intraoperative Complications
Postoperative Complications
Laparoscopy
Surgical Complications From General Anesthesia
Ventilator-Induced Lung Injury
Intervention Drug: Rocuronium
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Deep Neuromuscular Block (NMB) Moderate Neuromuscular Block (NMB)
Hide Arm/Group Description

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).

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).

Period Title: Overall Study
Started 16 21
Completed 16 19
Not Completed 0 2
Arm/Group Title Deep Neuromuscular Block (NMB) Moderate Neuromuscular Block (NMB) Total
Hide Arm/Group Description

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).

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 of all reporting groups
Overall Number of Baseline Participants 16 19 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 19 participants 35 participants
56.6  (11.9) 60.7  (9.6) 58.7  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 19 participants 35 participants
Female
5
  31.3%
4
  21.1%
9
  25.7%
Male
11
  68.8%
15
  78.9%
26
  74.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 16 participants 19 participants 35 participants
16
 100.0%
19
 100.0%
35
 100.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 16 participants 19 participants 35 participants
29.7  (8.1) 28.0  (4.5) 28.3  (7.7)
ASA Physical Status Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 19 participants 35 participants
I
1
   6.3%
2
  10.5%
3
   8.6%
II
15
  93.8%
17
  89.5%
32
  91.4%
[1]
Measure Description: ASA I A normal healthy patient ASA II A patient with mild systemic disease
1.Primary Outcome
Title Regional Change in Air Content (Delta Z, %)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
Overall Number of Participants Analyzed 16 16 16 19 19 19
Mean (Standard Deviation)
Unit of Measure: percent change
14.5  (51.6) 29.0  (43.0) 43.3  (39.9) -14.0  (40.2) 19.4  (41.2) 29.8  (38.2)
2.Primary Outcome
Title Ejection Fraction (%)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
Overall Number of Participants Analyzed 16 16 16 19 19 19
Mean (Standard Deviation)
Unit of Measure: % fractional shortening
36  (5) 34  (5) 35  (4) 35  (5) 36  (2) 37  (6)
3.Primary Outcome
Title Cerebral Oximetry (%)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
Overall Number of Participants Analyzed 16 16 16 19 19 19
Mean (Standard Deviation)
Unit of Measure: percent cerebral saturation
74  (6) 73  (5) 74  (6) 75  (6) 75  (6) 75  (7)
4.Secondary Outcome
Title Postoperative Pain
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Block (NMB) Moderate Neuromuscular Block (NMB)
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 16 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.5  (2.0) 3.1  (2.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Deep Neuromuscular Block (NMB) Moderate Neuromuscular Block (NMB)
Hide Arm/Group Description

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).

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).

All-Cause Mortality
Deep Neuromuscular Block (NMB) Moderate Neuromuscular Block (NMB)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Deep Neuromuscular Block (NMB) Moderate Neuromuscular Block (NMB)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Deep Neuromuscular Block (NMB) Moderate Neuromuscular Block (NMB)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marcos Vidal Melo, MD, PhD
Organization: Massachusetts General Hospital
Phone: 617-726-8980
EMail: VidalMelo.Marcos@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Marcos Vidal Melo, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02025075    
Other Study ID Numbers: Merck-50706
First Submitted: December 19, 2013
First Posted: December 31, 2013
Results First Submitted: March 9, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017