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Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile (Neuropa)

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ClinicalTrials.gov Identifier: NCT02243943
Recruitment Status : Completed
First Posted : September 18, 2014
Results First Posted : August 25, 2016
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Albert Dahan, Leiden University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Postoperative Respiratory Condition
Interventions Drug: Sugammadex
Drug: Neostigmine
Enrollment 100

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sugammadex Neostigmine
Hide Arm/Group Description

Subjects in this arm will be reversed with sugammadex 2-4 mg/kg

Sugammadex

subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Neostigmine

Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Sugammadex Neostigmine Total
Hide Arm/Group Description

Subjects in this arm will be reversed with sugammadex 2-4 mg/kg

Sugammadex

subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Neostigmine

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years of age
Number Analyzed 50 participants 50 participants 100 participants
55
(27 to 72)
55
(19 to 94)
55
(19 to 94)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
27
  54.0%
24
  48.0%
51
  51.0%
Male
23
  46.0%
26
  52.0%
49
  49.0%
1.Primary Outcome
Title Mean Lowest Saturation
Hide Description Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery
Time Frame 45 minutes post surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugammadex Neostigmine
Hide Arm/Group Description:

Subjects in this arm will be reversed with sugammadex 2-4 mg/kg

Sugammadex

subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Neostigmine

Overall Number of Participants Analyzed 50 50
Mean (95% Confidence Interval)
Unit of Measure: percentage of oxygen saturation
96.8
(96.1 to 97.4)
93.3
(91.9 to 94.7)
2.Secondary Outcome
Title Pain
Hide Description using the 1-10 numeric rating scale
Time Frame 45 minutes post surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugammadex Neostigmine
Hide Arm/Group Description:

Subjects in this arm will be reversed with sugammadex 2-4 mg/kg

Sugammadex

subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Neostigmine

Overall Number of Participants Analyzed 50 50
Mean (95% Confidence Interval)
Unit of Measure: Numeric rating scale. 1(low)-10(maximum)
3.0
(2.3 to 3.7)
3.2
(2.4 to 4.0)
3.Secondary Outcome
Title Sedation
Hide Description using the Leiden observer alertness score (1 alert - 5 sedated)
Time Frame 45 minutes post surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugammadex Neostigmine
Hide Arm/Group Description:

Subjects in this arm will be reversed with sugammadex 2-4 mg/kg

Sugammadex

subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Neostigmine

Overall Number of Participants Analyzed 50 50
Mean (95% Confidence Interval)
Unit of Measure: sedation scale (1 alert - 5 sedated)
1.4
(1.2 to 1.6)
1.4
(1.2 to 1.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugammadex Neostigmine
Hide Arm/Group Description

Subjects in this arm will be reversed with sugammadex 2-4 mg/kg

Sugammadex

subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg

Neostigmine

All-Cause Mortality
Sugammadex Neostigmine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sugammadex Neostigmine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sugammadex Neostigmine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Prof Dr A. Dahan
Organization: LUMC
Phone: +31 71 526 2301
Responsible Party: Albert Dahan, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02243943     History of Changes
Other Study ID Numbers: NL34186.058.10
NL34186.058.10 ( Other Identifier: LUMC )
First Submitted: September 12, 2014
First Posted: September 18, 2014
Results First Submitted: July 14, 2016
Results First Posted: August 25, 2016
Last Update Posted: February 6, 2017