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Trial record 51 of 186 for:    GLYCOPYRROLATE

CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity (CURES)

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ClinicalTrials.gov Identifier: NCT01748643
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Pascal Vanelderen, Ziekenhuis Oost-Limburg

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Obesity
Laparoscopic Gastric Bypass Surgery
Surgical Conditions
Respiratory Function
Cerebral Tissue Oxygenation
Interventions Drug: deep neuromuscular blockade with rocuronium, reversal with sugammadex
Drug: normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Hide Arm/Group Description

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine Total
Hide Arm/Group Description

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
41  (13) 42  (11) 41.6  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
8
  26.7%
4
  13.3%
12
  20.0%
Male
22
  73.3%
26
  86.7%
48
  80.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Belgium Number Analyzed 30 participants 30 participants 60 participants
30
 100.0%
30
 100.0%
60
 100.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 30 participants 30 participants 60 participants
40  (3) 41  (7) 41  (5)
Peak expiratory flow  
Mean (Standard Deviation)
Unit of measure:  L/min
Number Analyzed 30 participants 30 participants 60 participants
314  (109) 276  (81) 295  (97)
Forced expiratory volume in 1 second  
Mean (Standard Deviation)
Unit of measure:  L/min
Number Analyzed 30 participants 30 participants 60 participants
2.4  (0.9) 2.2  (0.6) 2.3  (0.7)
Forced vital capacity  
Mean (Standard Deviation)
Unit of measure:  L/min
Number Analyzed 30 participants 30 participants 60 participants
3.0  (0.9) 2.7  (0.8) 2.8  (0.8)
1.Primary Outcome
Title Subjective Evaluation of the View on the Operating Field by the Surgeon
Hide Description

At the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale:

  1. Extremely poor
  2. Poor
  3. Acceptable
  4. Good
  5. Optimal
Time Frame Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Hide Arm/Group Description:

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.2  (1.0) 3.9  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Reversal With Sugammadex, Normal Neuromuscular Blockade, Reversal With Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Number of Intra-abdominal Pressure Rises > 18cmH2O
Hide Description The number of intra-abdominal pressure rises > 18cmH2O detected by the intra-abdominal CO2 insufflator.
Time Frame Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Hide Arm/Group Description:

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: number of intra-abdominal pressure rises
0.2  (0.9) 0.3  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Reversal With Sugammadex, Normal Neuromuscular Blockade, Reversal With Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Duration of Surgery
Hide Description Measured from the time of first skin incision to completion of skin closure.
Time Frame Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Hide Arm/Group Description:

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: minutes
61.3  (15.1) 70.6  (20.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Reversal With Sugammadex, Normal Neuromuscular Blockade, Reversal With Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Peak Expiratory Flow
Hide Description Peak expiratory flow is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.
Time Frame Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Hide Arm/Group Description:

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
51.3  (31.6) 51.5  (19.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Reversal With Sugammadex, Normal Neuromuscular Blockade, Reversal With Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
5.Secondary Outcome
Title Forced Expiratory Volume in 1 Second
Hide Description Forced expiratory volume in 1 second is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.
Time Frame Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Hide Arm/Group Description:

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
45.2  (36.4) 48.8  (19.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Reversal With Sugammadex, Normal Neuromuscular Blockade, Reversal With Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
6.Secondary Outcome
Title Forced Vital Capacity
Hide Description Forced vital capacity is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.
Time Frame Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Hide Arm/Group Description:

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percent change from baseline
51.9  (16.4) 49.0  (22.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Reversal With Sugammadex, Normal Neuromuscular Blockade, Reversal With Neostigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Hide Arm/Group Description

a continuous rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with Sugammadex 4mg/kg. Patients are extubated when the train of four ratio is > 0.9.

deep neuromuscular blockade with rocuronium, reversal with sugammadex: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when TOF ratio > 0.9.

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine: After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.

All-Cause Mortality
Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Deep Neuromuscular Blockade, Reversal With Sugammadex Normal Neuromuscular Blockade, Reversal With Neostigmine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Pascal Vanelderen
Organization: Ziekenhuis Oost-Limburg
Phone: +3289325298
EMail: pascal.vanelderen@gmail.com
Publications:
Layout table for additonal information
Responsible Party: Pascal Vanelderen, Ziekenhuis Oost-Limburg
ClinicalTrials.gov Identifier: NCT01748643     History of Changes
Other Study ID Numbers: PVRA-01
2012-005533-37 ( EudraCT Number )
8616-085MISP ( Other Grant/Funding Number: MISP )
First Submitted: December 6, 2012
First Posted: December 12, 2012
Results First Submitted: March 13, 2017
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017