A Phase 4 interventional study of Neostigmine and Glycopyrrolate in Neuromuscular Blockade and Anesthesia, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-16.
Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Treatment
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The aim of this study is to evaluate whether the use of Sugammadex for reversing the neuromuscular blocking effects of rocuronium during neurointerventional procedures can speed recovery of neuromuscular function. Half of participates will receive Neostigmine with glycopyrrolate, while the other half will receive Sugammadex.
Incomplete recovery from neuromuscular blocking agents (NMBAs) residual block after anesthesia and surgery continues to be a common problem in the postanesthesia care (PACU).
Neostigmine remains the most common acetylcholinesterase inhibitor in the United States. However, administration of the drug significantly impairs genioglossus muscle activity when administered after full recovery from neuromuscular block. Moreover, doses of neostigmine exceeding 0.06 mg/kg increase the risk of respiratory complications independent of NMBAs effects.
Sugammadex is a modified γ-cyclodextrin that rapidly reverses that effect of the steroidal nondepolarizing NMBAs rocuronium and vecuronium. Sugammadex forms a stable, inactive 1:1 complex with rocuronium or vecuronium, reducing the amount of free NMBA available to bind to nicotinic acetylcholine receptors at the neuromuscular junction. Unlike neostigmine, sugammadex completely reverses even dense neuromuscular blocks.
Patients having catheter-based neurointerventional procedures are kept deeply anesthetized. It is common to find patients nearly completely paralyzed at the end of neurointerventional procedures and have a markedly delayed emergence while waiting for muscle function to recover sufficiently to safely antagonize with neostigmine.
The Cleveland Clinic is the lead sponsor of 832 studies on the registry; 120 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Neostigmine · Drug: Glycopyrrolate
Sugammadex 4 mg/kg at the end surgery
Drug: Sugammadex
Neostigmine injection
Glycopyrrolate injection
Sugammadex injection
Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent
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.
Time frame: within 90 minutes after endotracheal extubation
TOF Ratio at 90 Min
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.
Time frame: at 90 minutes after the administration of the reversal agent
The Time for Extubation After Administration of Reversal Agents
Time from administration of reversal agent to tracheal extubation
Time frame: Up to 4 hours after administration of reversal agents
Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.
Time frame: from baseline to 90 minutes after the administration of the reversal agent
Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.
Time frame: from baseline to 90 minutes after the administration of reversal agent
| Milestone | Neostigmine With Glycopyrrolate | Sugammadex |
|---|---|---|
| Started | 34 | 35 |
| Completed | 33 | 35 |
| Not completed | 1 | 0 |
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.
| minutes | Neostigmine With Glycopyrrolate | Sugammadex |
|---|---|---|
| Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent | 8 (6 to 10) | 3 (2 to 3) |
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.
| ratio | Neostigmine With Glycopyrrolate | Sugammadex |
|---|---|---|
| TOF Ratio at 90 Min | 1.07 (1 to 1.14) | 1.16 (1.02 to 1.26) |
Time from administration of reversal agent to tracheal extubation
| minutes | Neostigmine With Glycopyrrolate | Sugammadex |
|---|---|---|
| The Time for Extubation After Administration of Reversal Agents | 8 (6 to 10) | 8 (6 to 11) |
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.
| cm/s | Neostigmine With Glycopyrrolate | Sugammadex |
|---|---|---|
| Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s | -0.04 ± 0.85 | 0.29 ± 1.13 |
The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.
| cm/s | Neostigmine With Glycopyrrolate | Sugammadex |
|---|---|---|
| Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s | -0.02 ± 1.43 | 0.80 ± 1.51 |
Collected over Until hospital discharge or 30 days after surgery, which came first. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neostigmine With Glycopyrrolate | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Sugammadex | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Continuous(years) | Neostigmine With Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| Mean | 59 ± 12 | 54 ± 15 | 56 ± 14 |
| Sex: Female, Male(Participants) | Neostigmine With Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| Female | 19 | 27 | 46 |
| Male | 14 | 8 | 22 |
| Race/Ethnicity, Customized(Participants) | Neostigmine With Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| Race — Afirican American | 3 | 3 | 6 |
| Race — Asian | 1 | 0 | 1 |
| Race — Caucasian | 29 | 32 | 61 |
| Weight(kg) | Neostigmine With Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| Mean | 90 ± 32 | 92 ± 38 | 91 ± 35 |
| ASA(Participants) | Neostigmine With Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| II | 3 | 3 | 6 |
| III | 32 | 32 | 64 |
| Arterial hypertension(Participants) | Neostigmine With Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| Count of participants | 20 | 23 | 43 |
| Asthma(Participants) | Neostigmine With Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| Count of participants | 3 | 3 | 6 |
| Chronic pulmonary disease(Participants) | Neostigmine With Glycopyrrolate | Sugammadex | Total |
|---|---|---|---|
| Count of participants | 5 | 3 | 8 |
21 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Dec 2020, 37 months.
Results were first posted in Apr 2021, 3 months after primary completion.
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Studies of the drug tested here: Sugammadex