NCT03460509

Reversal With Low Doses of Sugammadex in Patients Undergoing Non-cardiac Surgery

A Randomized Double Blind Trial Comparing Reversal With Low Doses Of Sugammadex aFter Rocuronium-induced Neuromuscular Block Under General Anesthesia in Patients Undergoing Non-cardiac Surgery(TOF TRIAL)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: The Hospital of Vestfold · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.Recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block. Hypotheses: 1. Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse (TOF=0.9) rocuronium induced neuromuscular block within 10 min. 2. Recurrent block (TOF ratio \< 0.9) does not occur after reversal with low dose sugammadex 0.25 mg/kg. The primary objective of this trial is to assess the dose-response characteristics of sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal effective dose Secondary objective is to assess the safety of different doses of sugammadex (recurrent block (TOF ratio \< 0.9) after reversal and the occurrence of adverse reactions) Sugammadex is a very expensive drug which limits its use i anaesthesia department. By optimising drug dosage it may have economic impact and contribute to a wider use of sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete recovery. This may lead to less risk for postoperative pulmonary complications and thereby reduce morbidity and mortality after surgery.

Detailed description

Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal.

Conditions

• Postoperative Residual Curarization
• Neuromuscular Block

Interventions

Type	Name	Description
DRUG	Sugammadex	Dose-response

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-03-09
• Last updated: 2018-05-30