NCT03322657

Sugammadex Versus Neostigmine for Reversal of Rocuronium Neuromuscular

Completed Phase 4 Results posted Last updated 16 November 2021

What this trial tests

Phase 4 trial testing Neostigmine in Neuromuscular Blockade in 69 participants. Completed in 1 February 2021.

Timeline

14 November 2017

Primary endpoint
31 December 2020

1 February 2021

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	69
Start date	14 November 2017
Primary completion	31 December 2020
Estimated completion	1 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Neostigmine (NEOSTIGMINE) — full drug profile →
• Glycopyrrolate — full drug profile →
• Sugammadex — full drug profile →

Conditions studied

• Neuromuscular Blockade — all drugs for Neuromuscular Blockade →
• Anesthesia — all drugs for Anesthesia →

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Neuromuscular Blockade or Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time in Minutes to Reach Train of Four (TOF) Ratio ≥ 0.9 After the Administration of Reversal Agent Primary · within 90 minutes after endotracheal extubation

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.

Group	Value	95% CI
Neostigmine With Glycopyrrolate	8	6 – 10
Sugammadex	3	2 – 3

TOF Ratio at 90 Min Primary · at 90 minutes after the administration of the reversal agent

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 ana

Group	Value	95% CI
Neostigmine With Glycopyrrolate	1.07	1 – 1.14
Sugammadex	1.16	1.02 – 1.26

The Time for Extubation After Administration of Reversal Agents Secondary · Up to 4 hours after administration of reversal agents

Time from administration of reversal agent to tracheal extubation

Group	Value	95% CI
Neostigmine With Glycopyrrolate	8	6 – 10
Sugammadex	8	6 – 11

Change of Diaphragmatic Contractility Speed- Sniff (Breathing From the Nose), cm/s Secondary · from baseline to 90 minutes after the administration of the reversal agent

The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.

Group	Value	95% CI
Neostigmine With Glycopyrrolate	-0.04	± 0.85
Sugammadex	0.29	± 1.13

Change of Diaphragmatic Contractility Speed, Deep Breathing From Mouth, cm/s Secondary · from baseline to 90 minutes after the administration of reversal agent

The change of diaphragmatic contractility speed was defined as baseline minus postoperative diaphragmatic contraction.

Group	Value	95% CI
Neostigmine With Glycopyrrolate	-0.02	± 1.43
Sugammadex	0.80	± 1.51

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.