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Completed

NCT Number: NCT03656614

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

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.

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Other names: Bridion, Org 25969

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.

Other names: Prostigmin

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%.

Other names: Placebo

Primary outcomes

  1. Time to TOF 0.9 after the administration of reversal agent

    Time frame: the general anesthesia time 1 hour at least

    The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration.

Secondary outcomes

  1. incidence of reparalysis

    Time frame: approximately 1 hour

    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)

  2. incidence of adverse event

    Time frame: the general anesthesia and recovery time 2 hours at least

    Documenting whether patients will have some adverse events(such as hypoxia bradycardia nausea and vomiting) from anesthesia commence to PACU departure.

Sponsors and collaborators

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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