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

NCT ID: NCT03656614

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-26
• Study Completion Date: 2019-06-30

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.

Detailed 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.

Conditions

Neuromuscular Blockade

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

sugammadex 0.125

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

Sugammadex

Intervention Type: 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)

Sugammadex 0.25

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

Sugammadex

Intervention Type: 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)

Sugammadex 0.5

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

Sugammadex

Intervention Type: 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)

Sugammadex 1.0

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

Sugammadex

Intervention Type: 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)

Sugammadex 2.0

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

Sugammadex

Intervention Type: 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)

Neostigmine 10

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

Neostigmine

Intervention Type: 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.

Neostigmine 25

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

Neostigmine

Intervention Type: 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.

Neostigmine 40

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

Neostigmine

Intervention Type: 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.

Neostigmine 55

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

Neostigmine

Intervention Type: 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.

Neostigmine 70

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

Neostigmine

Intervention Type: 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.

Placebo

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

Saline 0.9%

Intervention Type: 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%.

Interventions

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)

Intervention Type: DRUG

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.

Intervention Type: DRUG

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%.

Intervention Type: DRUG

Other Intervention Names

Bridion; Org 25969; Prostigmin; Placebo

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role: lead

Responsible Party

bo xu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 23665915 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20885293 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26787792 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34435439 (View on PubMed)

Other Identifiers

Reversal Neuromuscular Block

Identifier Type: -

Identifier Source: org_study_id