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Trial record 35 of 185 for:    GLYCOPYRROLATE

Study to Determine if Administration of Sugammadex Impacts Hospital Efficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860507
Recruitment Status : Completed
First Posted : August 9, 2016
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Enrico Camporesi, University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neuromuscular Blockade
Interventions Drug: sugammadex
Drug: Neostigmine
Drug: Glycopyrrolate
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neostigmine + Glycopyrrolate Sugammadex
Hide Arm/Group Description

Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv

Neostigmine

Glycopyrrolate

Sugammadex 4mg/kg

sugammadex

Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Neostigmine + Glycopyrrolate Sugammadex Total
Hide Arm/Group Description

Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv

Neostigmine

Glycopyrrolate

Sugammadex 4mg/kg

sugammadex

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
44.3  (5.2) 45.6  (6.4) 45.2  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
11
  44.0%
12
  48.0%
23
  46.0%
Male
14
  56.0%
13
  52.0%
27
  54.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Hispanic or Latino
4
  16.0%
6
  24.0%
10
  20.0%
Not Hispanic or Latino
21
  84.0%
19
  76.0%
40
  80.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.0%
0
   0.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.0%
1
   4.0%
4
   8.0%
White
18
  72.0%
22
  88.0%
40
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  12.0%
2
   8.0%
5
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
Hide Description [Not Specified]
Time Frame through start of next surgery, average of 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neostigmine + Glycopyrrolate Sugammadex
Hide Arm/Group Description:

Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv

Neostigmine

Glycopyrrolate

Sugammadex 4mg/kg

sugammadex

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Minutes
49.7  (16.18) 49.45  (16.67)
2.Secondary Outcome
Title Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications
Hide Description [Not Specified]
Time Frame through discharge from hospital, average of 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neostigmine + Glycopyrrolate Sugammadex
Hide Arm/Group Description:

Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv

Neostigmine

Glycopyrrolate

Sugammadex 4mg/kg

sugammadex

Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
8
  32.0%
10
  40.0%
Time Frame Two days: collecting informed consent, and surgery (3 hours).
Adverse Event Reporting Description Study was purely observational, Interventions followed hospital standard of care practices
 
Arm/Group Title Neostigmine + Glycopyrrolate Sugammadex
Hide Arm/Group Description

Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv

Neostigmine

Glycopyrrolate

Sugammadex 4mg/kg

sugammadex

All-Cause Mortality
Neostigmine + Glycopyrrolate Sugammadex
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Neostigmine + Glycopyrrolate Sugammadex
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neostigmine + Glycopyrrolate Sugammadex
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (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: Chadwick Neal / Medical Affairs Director
Organization: Merck Pharmaceuticals
Phone: 2056010605
EMail: chadwick.neal@merck.com
Publications:
Layout table for additonal information
Responsible Party: Enrico Camporesi, University of South Florida
ClinicalTrials.gov Identifier: NCT02860507     History of Changes
Other Study ID Numbers: TGH015
First Submitted: August 2, 2016
First Posted: August 9, 2016
Results First Submitted: November 19, 2018
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019