Reversal of Residual Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine

Neuromuscular Blockade Clinical Trial

Official title:

Dose Finding Study for Reversal of Vecuronium-induced Neuromuscular Blockade at Train-of-four Ratio 0.3 With Sugammadex and Neostigmine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656614
• Other study ID #: Reversal Neuromuscular Block
• Status: Completed
• Start date: July 26, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2020
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.

Description:

Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.

Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 30, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1 age of 18 to 65 yr,

• 2 body mass index 18.5 to 25.0 kg/m2,

• 3 American Society of Anesthesiologists physical status I to III

• 4 scheduled for elective surgery with an expected duration of at least 60min under general anesthesia with intubation of the trachea or laryngeal mask

• 5 patients having given informed consent to the study

Exclusion Criteria:

• 1 patients who had participated in another clinical trial within 1 month

• 2 Patients with suspected difficult airway, bronchial asthma, chronic obstructive pulmonary disease

• 3 known neuromuscular disease

• 4 suspected malignant hyperthermia

• 5 hepatic or renal dysfunction

• 6 glaucoma

• 7 allergy to the medication that used in this trial

• 8 taking medicaments that might influence the effect of NMB agents

• 9 pregnant, or breastfeeding state

• 10 taking medication known to alter the effect of neuromuscular blocking agents( toremifene .etc)

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Sugammadex
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Sugammadex 0.125 mg/kg (sugammadex 0.125) Sugammadex 0.25 mg/kg (sugammadex 0.25) Sugammadex 0.5 mg/kg (sugammadex 0.5) Sugammadex 1.0 mg/kg (sugammadex 1.0) Sugammadex 2.0 mg/kg (sugammadex 2.0)
• Neostigmine
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Neostigmine 10 µg/kg (Neostigmine 10) Neostigmine 25 µg/kg (Neostigmine 25) Neostigmine 40 µg/kg (Neostigmine 40) Neostigmine 55 µg/kg (Neostigmine 55) Neostigmine 70 µg/kg (Neostigmine 70) Atropine will be administered with Neostigmine at a half dose of Neostigmine administered through an intravenous line with brisk flow.
• Saline 0.9%
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of saline 0.9%.

Locations

Country	Name	City	State
China	Guangzhou Military Region General Hospital, Department of Anesthesiology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

References & Publications (3)

Kaufhold N, Schaller SJ, Stäuble CG, Baumüller E, Ulm K, Blobner M, Fink H. Sugammadex and neostigmine dose-finding study for reversal of residual neuromuscular block at a train-of-four ratio of 0.2 (SUNDRO20)†,. Br J Anaesth. 2016 Feb;116(2):233-40. doi: 10.1093/bja/aev437. — View Citation

Pongrácz A, Szatmári S, Nemes R, Fülesdi B, Tassonyi E. Reversal of neuromuscular blockade with sugammadex at the reappearance of four twitches to train-of-four stimulation. Anesthesiology. 2013 Jul;119(1):36-42. doi: 10.1097/ALN.0b013e318297ce95. — View Citation

Schaller SJ, Fink H, Ulm K, Blobner M. Sugammadex and neostigmine dose-finding study for reversal of shallow residual neuromuscular block. Anesthesiology. 2010 Nov;113(5):1054-60. doi: 10.1097/ALN.0b013e3181f4182a. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to TOF 0.9 after the administration of reversal agent	The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration.	the general anesthesia time 1 hour at least
Secondary	incidence of reparalysis	Determining whether patients receiving reversal agent will have a train-to-four ratio <0.8 during total recovery time (from TOF reach 0.9 first time to post-anaesthesia care unit (PACU) departure)	approximately 1 hour
Secondary	incidence of adverse event	Documenting whether patients will have some adverse events(such as hypoxia bradycardia nausea and vomiting) from anesthesia commence to PACU departure.	the general anesthesia and recovery time 2 hours at least