Trial Outcomes & Findings for A Study to Compare Neostigmine vs Sugammadex in Length of PACU Stay in Patients Undergoing Sleeve Gastrectomy Surgery (NCT NCT03276026)
NCT ID: NCT03276026
Last Updated: 2019-05-28
Results Overview
Determine the difference in length of stay in the post anesthesia care unit from patient arrival until ready for post anesthesia care discharge for the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine in sleeve gastrectomy surgeries.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
68 participants
Primary outcome timeframe
Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).
Results posted on
2019-05-28
Participant Flow
Participant milestones
| Measure |
Control Group/Neostigmine
The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
Study Group/Sugammadex
33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.
Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
33
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Control Group/Neostigmine
The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
Study Group/Sugammadex
33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.
Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Study to Compare Neostigmine vs Sugammadex in Length of PACU Stay in Patients Undergoing Sleeve Gastrectomy Surgery
Baseline characteristics by cohort
| Measure |
Control Group/Neostigmine
n=34 Participants
The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
Study Group/Sugammadex
n=33 Participants
33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.
Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
43 years
n=5 Participants
|
42 years
n=7 Participants
|
42 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 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
|
1 Participants
n=5 Participants
|
0 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
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).Determine the difference in length of stay in the post anesthesia care unit from patient arrival until ready for post anesthesia care discharge for the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine in sleeve gastrectomy surgeries.
Outcome measures
| Measure |
Control Group/Neostigmine
n=34 Participants
The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
Study Group/Sugammadex
n=33 Participants
33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.
Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
|---|---|---|
|
Post Anesthesia Care Unit Length of Stay
|
121 minutes
Interval 47.0 to 185.0
|
119 minutes
Interval 47.0 to 248.0
|
SECONDARY outcome
Timeframe: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).Assess the incidence of Postoperative Nausea and Vomiting in the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine at arrival to the post anesthesia care unit and every 15 minutes while in the post anesthesia care unit, with the prediction that there will be a lower incidence of Postoperative Nausea and Vomiting in the Sugammadex group.
Outcome measures
| Measure |
Control Group/Neostigmine
n=34 Participants
The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
Study Group/Sugammadex
n=33 Participants
33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.
Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
|---|---|---|
|
Incidence of Postoperative Nausea and Vomiting
Positive for PONV
|
14 Participants
|
14 Participants
|
|
Incidence of Postoperative Nausea and Vomiting
Negative PONV
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).Assess the incidence of respiratory complications postoperatively specifically looking at oxygen saturation at patient arrival to the post anesthesia care unit and every 15 minutes after arrival to the post anesthesia care unit and any intervention necessary.
Outcome measures
| Measure |
Control Group/Neostigmine
n=34 Participants
The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
Study Group/Sugammadex
n=33 Participants
33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.
Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
|---|---|---|
|
Incidence of Respiratory Complications
Positive for Hypoxia
|
2 Participants
|
0 Participants
|
|
Incidence of Respiratory Complications
Negative for Hypoxia
|
32 Participants
|
33 Participants
|
Adverse Events
Control Group/Neostigmine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Study Group/Sugammadex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group/Neostigmine
n=34 participants at risk
The control group will be the 34 patients who receive Neostigmine in a dose of 5mg, along with the anti-cholinergic glycopyrrolate 0.6mg.
Neostigmine: Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
Study Group/Sugammadex
n=33 participants at risk
33 patients will be given Sugammadex in a dose of 2mg/kg if the train of four twitch count is 2 and 4mg/kg if the twitch response has reached 1-2 post-tetanic counts with no twitch response to train of four.
Sugammadex: Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Inability to recover spontaneous respirations post surgery
|
2.9%
1/34 • Number of events 1 • Adverse Events were collected from the time of signing the informed consent until the discharge from the PACU.
|
0.00%
0/33 • Adverse Events were collected from the time of signing the informed consent until the discharge from the PACU.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Physician shall submit each publication to the Virtua Clinical Trials Office for review and approval prior to publication or presentation, which approval shall not be unreasonably withheld.
- Publication restrictions are in place
Restriction type: OTHER