Trial Outcomes & Findings for Investigation of Sugammadex in Outpatient Urological Procedures (NCT NCT03138967)

Last Updated: 2020-09-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

Intraoperatively, up to 3 hours

Results posted on

2020-09-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Suggamadex or Treatment Group 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.	Neostigime/Glycopyrrolate or Standard of Care Group 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 Study STARTED	26	28
Overall Study Post-operative Day(POD) 1 Follow-up	25	25
Overall Study Post-operative Day(POD) 7 Follow-up	25	24
Overall Study COMPLETED	25	24
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Suggamadex or Treatment Group 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.	Neostigime/Glycopyrrolate or Standard of Care Group 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 Study Death	0	1
Overall Study Physician Decision	1	3

Baseline Characteristics

Investigation of Sugammadex in Outpatient Urological Procedures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suggamadex or Treatment Group n=26 Participants 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.	Neostigime/Glycopyrrolate or Standard of Care Group n=28 Participants 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 n=54 Participants Total of all reporting groups
Age, Continuous	67.1923 Years STANDARD_DEVIATION 8.04 • n=5 Participants	71.6071 Years STANDARD_DEVIATION 8.7235 • n=7 Participants	69.48 Years STANDARD_DEVIATION 8.61 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	25 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	28 participants n=7 Participants	54 participants n=5 Participants
Body Mass Index (BMI)	27.9385 kg/m^2 STANDARD_DEVIATION 5.7725 • n=5 Participants	28.7214 kg/m^2 STANDARD_DEVIATION 4.766 • n=7 Participants	28.34 kg/m^2 STANDARD_DEVIATION 5.24 • n=5 Participants

PRIMARY outcome

Timeframe: Intraoperatively, up to 3 hours

Outcome measures

Outcome measures
Measure	Suggamadex or Treatment Group n=25 Participants 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.	Neostigime/Glycopyrrolate or Standard of Care Group n=25 Participants 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.
Muscle Recovery Time	2 minutes Standard Deviation 0.6455	9.24 minutes Standard Deviation 7.8755

SECONDARY outcome

Timeframe: Post-operatively, up to 7 days

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.

Outcome measures

Outcome measures
Measure	Suggamadex or Treatment Group n=25 Participants 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.	Neostigime/Glycopyrrolate or Standard of Care Group n=25 Participants 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.
PostOperative Complications	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 3 hours after end of surgery

To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria.

Outcome measures

Outcome measures
Measure	Suggamadex or Treatment Group n=25 Participants 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.	Neostigime/Glycopyrrolate or Standard of Care Group n=25 Participants 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 Recovery Time	2.0847 hours Standard Deviation 0.8742	2.4727 hours Standard Deviation 2.0447

Adverse Events

Suggamadex or Treatment Group

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Neostigime/Glycopyrrolate or Standard of Care Group

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Suggamadex or Treatment Group n=25 participants at risk 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.	Neostigime/Glycopyrrolate or Standard of Care Group n=25 participants at risk 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.
Nervous system disorders Stroke	0.00% 0/25 • 7 days post surgery	4.0% 1/25 • 7 days post surgery

Other adverse events

Other adverse events
Measure	Suggamadex or Treatment Group n=25 participants at risk 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.	Neostigime/Glycopyrrolate or Standard of Care Group n=25 participants at risk 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.
Renal and urinary disorders Hematuria	4.0% 1/25 • 7 days post surgery	8.0% 2/25 • 7 days post surgery
Cardiac disorders Uncontrolled Hypertension	0.00% 0/25 • 7 days post surgery	4.0% 1/25 • 7 days post surgery
Skin and subcutaneous tissue disorders Laceration of penis' skin	4.0% 1/25 • 7 days post surgery	0.00% 0/25 • 7 days post surgery
Renal and urinary disorders Urinary Tract Infection	4.0% 1/25 • 7 days post surgery	0.00% 0/25 • 7 days post surgery
Renal and urinary disorders Hematuria with Clot retention	4.0% 1/25 • 7 days post surgery	4.0% 1/25 • 7 days post surgery
Gastrointestinal disorders Nausea	0.00% 0/25 • 7 days post surgery	4.0% 1/25 • 7 days post surgery
Skin and subcutaneous tissue disorders IV infiltration	0.00% 0/25 • 7 days post surgery	4.0% 1/25 • 7 days post surgery
Renal and urinary disorders Dysuria	4.0% 1/25 • 7 days post surgery	0.00% 0/25 • 7 days post surgery

Additional Information

Dr. Farzin Goravanchi / Anesthesiology & Perioperative Medicine

UT MD Anderson Cancer Center

Phone: 713-291-1163

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place