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Trial record 48 of 186 for:    GLYCOPYRROLATE

Investigation of Sugammadex in Outpatient Urological Procedures

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: NCT03138967
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Malignant Neoplasms of Urinary Tract
Bladder Cancer
Interventions Drug: Rocuronium
Drug: Sugammadex
Drug: Neostigmine
Drug: Glycopyrrolate
Enrollment 54
Recruitment Details Participants were screened within days of their scheduled eligible procedure. Enrolled 50 patients, 4 withdrew, we requested IRB approval to enroll 4 more to maintain statistical power. A total of 54 patients were enrolled in the study, but only 50 were assessed for the primary outcome, 1 participant died before POD-7 follow-up.
Pre-assignment Details  
Arm/Group Title Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group
Hide Arm/Group Description Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
Period Title: Overall Study
Started 26 28
Post-operative Day(POD) 1 Follow-up 25 25
Post-operative Day(POD) 7 Follow-up 25 24
Completed 25 24
Not Completed 1 4
Reason Not Completed
Death             0             1
Physician Decision             1             3
Arm/Group Title Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group Total
Hide Arm/Group Description Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg. Total of all reporting groups
Overall Number of Baseline Participants 26 28 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 28 participants 54 participants
67.1923  (8.04) 71.6071  (8.7235) 69.48  (8.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
Female 8 3 11
Male 18 25 43
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
American Indian or Alaska Native 0 0 0
Asian 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 1 2
White 22 21 43
More than one race 3 5 8
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 28 participants 54 participants
26 28 54
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 26 participants 28 participants 54 participants
27.9385  (5.7725) 28.7214  (4.766) 28.34  (5.24)
1.Primary Outcome
Title Muscle Recovery Time
Hide Description The primary outcome is to determine if Sugammadex can improve muscle recovery time, measured by time from administration of neuromuscular blockade reversal to train-of-four ratio of 0.9 in outpatient bladder procedures. It was assessed in the intraoperative period measuring the time from administration of reversal agent to TOF of 0.9 in minutes.
Time Frame Intraoperatively, up to 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group
Hide Arm/Group Description:
Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.
Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: minutes
2  (0.6455) 9.24  (7.8755)
2.Secondary Outcome
Title PostOperative Complications
Hide Description To determine if Sugammadex can improve post-operative complications for outpatient bladder procedures such as bladder perforation, nausea, vomiting, post-operative intubation and hospital admittance secondary to respiratory complications which was assessed uring follow ups on post-operative day 1 (POD1) and post-operative day 7 (POD7) looking for immediate postoperative complications such as bladder perforation, nausea, vomiting, postoperative intubation and hospital admittance secondary to respiratory complications and readmission within a week post-procedure for any other cause.
Time Frame Post-operatively, up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group
Hide Arm/Group Description:
Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.
Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
5
  20.0%
7
  28.0%
3.Secondary Outcome
Title Overall Recovery Time
Hide Description To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria.
Time Frame Up to 3 hours after end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group
Hide Arm/Group Description:
Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.
Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: hours
2.0847  (0.8742) 2.4727  (2.0447)
Time Frame 7 days post surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group
Hide Arm/Group Description Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient’s weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg.
All-Cause Mortality
Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   1/25 (4.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   1/25 (4.00%) 
Nervous system disorders     
Stroke  1  0/25 (0.00%)  1/25 (4.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Suggamadex or Treatment Group Neostigime/Glycopyrrolate or Standard of Care Group
Affected / at Risk (%) Affected / at Risk (%)
Total   5/25 (20.00%)   6/25 (24.00%) 
Cardiac disorders     
Uncontrolled Hypertension  1  0/25 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Nausea  1  0/25 (0.00%)  1/25 (4.00%) 
Renal and urinary disorders     
Hematuria  1  1/25 (4.00%)  2/25 (8.00%) 
Urinary Tract Infection  1  1/25 (4.00%)  0/25 (0.00%) 
Hematuria with Clot retention  1  1/25 (4.00%)  1/25 (4.00%) 
Dysuria  1  1/25 (4.00%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders     
Laceration of penis' skin  1  1/25 (4.00%)  0/25 (0.00%) 
IV infiltration  1  0/25 (0.00%)  1/25 (4.00%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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: Dr. Farzin Goravanchi / Anesthesiology & Perioperative Medicine
Organization: UT MD Anderson Cancer Center
Phone: 713-291-1163
EMail: fgoravan@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03138967     History of Changes
Other Study ID Numbers: 2015-1007
First Submitted: May 1, 2017
First Posted: May 3, 2017
Results First Submitted: June 27, 2019
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019