Trial Outcomes & Findings for Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular (NCT NCT03322657)
NCT ID: NCT03322657
Last Updated: 2021-11-16
Results Overview
The primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent.
COMPLETED
PHASE4
69 participants
within 90 minutes after endotracheal extubation
2021-11-16
Participant Flow
Participant milestones
| Measure |
Neostigmine With Glycopyrrolate
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
Neostigmine: Neostigmine injection
Glycopyrrolate: Glycopyrrolate injection
|
Sugammadex
Sugammadex 4 mg/kg at the end surgery
Sugammadex: Sugammadex injection
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
|
Overall Study
COMPLETED
|
33
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular
Baseline characteristics by cohort
| Measure |
Neostigmine With Glycopyrrolate
n=33 Participants
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
Neostigmine: Neostigmine injection
Glycopyrrolate: Glycopyrrolate injection
|
Sugammadex
n=35 Participants
Sugammadex 4 mg/kg at the end surgery
Sugammadex: Sugammadex injection
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 12 • n=99 Participants
|
54 years
STANDARD_DEVIATION 15 • n=107 Participants
|
56 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Afirican American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
29 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Weight
|
90 kg
STANDARD_DEVIATION 32 • n=99 Participants
|
92 kg
STANDARD_DEVIATION 38 • n=107 Participants
|
91 kg
STANDARD_DEVIATION 35 • n=206 Participants
|
|
ASA
II
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
ASA
III
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Arterial hypertension
|
20 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Asthma
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Chronic pulmonary disease
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Obstructive sleep apnea
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Diabetes mellitus
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Myocardial infarction
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ischemic heart disease
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Neurologic diseases
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Chronic pain requiring opioids
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Current smoker
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Current recreational drug user
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Alcohol abuse
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Cancer
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
No medical history
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Intraoperative remifentanil
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Intraoperative remifentanil, μg
|
0 μg
n=99 Participants
|
0 μg
n=107 Participants
|
0 μg
n=206 Participants
|
|
Intraoperative fentanyl
|
33 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Intraoperative fentanyl, mg
|
0.10 mg
n=99 Participants
|
0.10 mg
n=107 Participants
|
0.10 mg
n=206 Participants
|
|
Intraoperative propofol, mg
|
200 mg
n=99 Participants
|
200 mg
n=107 Participants
|
200 mg
n=206 Participants
|
|
Intraoperative midazolam, mg
|
0 mg
n=99 Participants
|
0 mg
n=107 Participants
|
0 mg
n=206 Participants
|
|
Intraoperative Phenylephrine
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Intraoperative Ephedrine
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Intraoperative Norepinephrine
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Time-weighted average minimum alveolar concentration
|
0.79 percent at 1 atmosphere
n=99 Participants
|
0.78 percent at 1 atmosphere
n=107 Participants
|
0.78 percent at 1 atmosphere
n=206 Participants
|
PRIMARY outcome
Timeframe: within 90 minutes after endotracheal extubationThe primary outcome was a time-to-TOF ratio ≥ 0.9 after the administration of the reversal agent. The TOF ratio was measured in a continuous manner every 12 seconds from the administration of the reversal drug until TOF ratio ≥ 0.9 or until 90 minutes after administration of the reversal agent.
Outcome measures
| Measure |
Neostigmine With Glycopyrrolate
n=33 Participants
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
Neostigmine: Neostigmine injection
Glycopyrrolate: Glycopyrrolate injection
|
Sugammadex
n=35 Participants
Sugammadex 4 mg/kg at the end surgery
Sugammadex: Sugammadex injection
|
|---|---|---|
|
Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent
|
8 minutes
Interval 6.0 to 10.0
|
3 minutes
Interval 2.0 to 3.0
|
PRIMARY outcome
Timeframe: at 90 minutes after the administration of the reversal agentPopulation: Eight patients were removed due to missing TOF at 90 min or TOF count not larger than 4.
TOF (train of four), also known as a peripheral nerve stimulator, is used to assess nerve function in patients receiving neuromuscular blocking agents (paralytic medications). Before giving the medications, the baseline must be measured because this tells how much electrical stimulation the patient needs for nerve stimulation without any paralytic on board. Our primary outcome TOF ratio between TOF at 90 minutes after the administration of the reversal agent versus the TOF at baseline tells us how well the treatment is working to reverse the rocuronium Neuromuscular. This is a sensitivity analysis of primary analysis.
Outcome measures
| Measure |
Neostigmine With Glycopyrrolate
n=28 Participants
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
Neostigmine: Neostigmine injection
Glycopyrrolate: Glycopyrrolate injection
|
Sugammadex
n=32 Participants
Sugammadex 4 mg/kg at the end surgery
Sugammadex: Sugammadex injection
|
|---|---|---|
|
TOF Ratio at 90 Min
|
1.07 ratio
Interval 1.0 to 1.14
|
1.16 ratio
Interval 1.02 to 1.26
|
SECONDARY outcome
Timeframe: Up to 4 hours after administration of reversal agentsTime from administration of reversal agent to tracheal extubation
Outcome measures
| Measure |
Neostigmine With Glycopyrrolate
n=33 Participants
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
Neostigmine: Neostigmine injection
Glycopyrrolate: Glycopyrrolate injection
|
Sugammadex
n=35 Participants
Sugammadex 4 mg/kg at the end surgery
Sugammadex: Sugammadex injection
|
|---|---|---|
|
The Time for Extubation After Administration of Reversal Agents
|
8 minutes
Interval 6.0 to 10.0
|
8 minutes
Interval 6.0 to 11.0
|
SECONDARY outcome
Timeframe: from baseline to 90 minutes after the administration of the reversal agentPopulation: There were 6 (17%) missing in sugammadex group and 5 (15%) missing in neostigmine group on diaphragmatic function outcomes.
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.
Outcome measures
| Measure |
Neostigmine With Glycopyrrolate
n=28 Participants
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
Neostigmine: Neostigmine injection
Glycopyrrolate: Glycopyrrolate injection
|
Sugammadex
n=29 Participants
Sugammadex 4 mg/kg at the end surgery
Sugammadex: Sugammadex injection
|
|---|---|---|
|
Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s
|
-0.04 cm/s
Standard Deviation 0.85
|
0.29 cm/s
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: from baseline to 90 minutes after the administration of reversal agentPopulation: There were 6 (17%) missing in sugammadex group and 5 (15%) missing in neostigmine group on diaphragmatic function outcomes.
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.
Outcome measures
| Measure |
Neostigmine With Glycopyrrolate
n=28 Participants
Neostigmine 0. 07 mg/kg with glycopyrrolate 0.01 mg/kg with ceiling dose of 5 mg neostigmine with 1 mg of glycopyrrolate at the end surgery
Neostigmine: Neostigmine injection
Glycopyrrolate: Glycopyrrolate injection
|
Sugammadex
n=29 Participants
Sugammadex 4 mg/kg at the end surgery
Sugammadex: Sugammadex injection
|
|---|---|---|
|
Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s
|
-0.02 cm/s
Standard Deviation 1.43
|
0.80 cm/s
Standard Deviation 1.51
|
Adverse Events
Neostigmine With Glycopyrrolate
Sugammadex
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place