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

NCT03656614 | Completed

• 1 other identifier: Reversal Neuromuscular Block
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Blockade

Keywords

sugammadex neostigmine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• incidence of reparalysis

  approximately 1 hour

• incidence of adverse event

  the general anesthesia and recovery time 2 hours at least

Study Arms (11)

sugammadex 0.125

Sugammadex group: sugammadex 0.125 mg/kg IV once at the reappearance of TOF 0.3

Drug: Sugammadex

Sugammadex 0.25

Sugammadex group: sugammadex 0.25 mg/kg IV once at the reappearance of TOF 0.3

Drug: Sugammadex

Sugammadex 0.5

Sugammadex group: sugammadex 0.5 mg/kg IV once at the reappearance of TOF 0.3

Drug: Sugammadex

Sugammadex 1.0

Sugammadex group: sugammadex 1.0 mg/kg IV once at the reappearance of TOF 0.3

Drug: Sugammadex

Sugammadex 2.0

Sugammadex group: sugammadex 2.0 mg/kg IV once at the reappearance of TOF 0.3

Drug: Sugammadex

Neostigmine 10

Neostigmine group: neostigmine 10 µg/kg IV once at the reappearance of TOF 0.3

Drug: Neostigmine

Neostigmine 25

Neostigmine group: neostigmine 25 µg/kg IV once at the reappearance of TOF 0.3

Drug: Neostigmine

Neostigmine 40

Neostigmine group: neostigmine 40 µg/kg IV once at the reappearance of TOF 0.3

Drug: Neostigmine

Neostigmine 55

Neostigmine group: neostigmine 55 µg/kg IV once at the reappearance of TOF 0.3

Drug: Neostigmine

Neostigmine 70

Neostigmine group: neostigmine 70 µg/kg IV once at the reappearance of TOF 0.3

Drug: Neostigmine

Placebo

Placebo group: Saline 0.9% IV once at the reappearance of TOF 0.3

Drug: Saline 0.9%

Interventions

Sugammadex DRUG

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)

Also known as: Bridion, Org 25969

Sugammadex 0.25; Sugammadex 0.5; Sugammadex 1.0; Sugammadex 2.0; sugammadex 0.125

Neostigmine DRUG

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.

Also known as: Prostigmin

Neostigmine 10; Neostigmine 25; Neostigmine 40; Neostigmine 55; Neostigmine 70

Saline 0.9% DRUG

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%.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

people scheduled for elective surgery

You may qualify if:

• age of 18 to 65 yr,
• body mass index 18.5 to 25.0 kg/m2,
• American Society of Anesthesiologists physical status I to III
• scheduled for elective surgery with an expected duration of at least 60min under general anesthesia with intubation of the trachea or laryngeal mask
• patients having given informed consent to the study

You may not qualify if:

• patients who had participated in another clinical trial within 1 month
• Patients with suspected difficult airway, bronchial asthma, chronic obstructive pulmonary disease
• known neuromuscular disease
• suspected malignant hyperthermia
• hepatic or renal dysfunction
• glaucoma
• allergy to the medication that used in this trial
• taking medicaments that might influence the effect of NMB agents
• pregnant, or breastfeeding state
• taking medication known to alter the effect of neuromuscular blocking agents( toremifene .etc)

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

Location

Related Publications (4)

• Pongracz A, Szatmari S, Nemes R, Fulesdi 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.

  PMID: 23665915 BACKGROUND

• 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.

  PMID: 20885293 BACKGROUND

• Kaufhold N, Schaller SJ, Stauble CG, Baumuller 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)dagger, Br J Anaesth. 2016 Feb;116(2):233-40. doi: 10.1093/bja/aev437.

  PMID: 26787792 BACKGROUND

• He J, He H, Li X, Sun M, Lai Z, Xu B. Required dose of sugammadex or neostigmine for reversal of vecuronium-induced shallow residual neuromuscular block at a train-of-four ratio of 0.3. Clin Transl Sci. 2022 Jan;15(1):234-243. doi: 10.1111/cts.13143. Epub 2021 Nov 2.

  PMID: 34435439 DERIVED

MeSH Terms

Interventions

Sugammadex; Neostigmine; Sodium Chloride

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: September 4, 2018
• Study Start: July 26, 2018
• Primary Completion: June 28, 2019
• Study Completion: June 30, 2019
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

CN (1)