Reversal of neuromuscular block using sugammadex

Reversal of residual rocuronium neuromuscular block using sugammadex: a prospective, dobule-blind, randomized, controlled, dose-finding study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001683-22-HU

Enrollment

Registered

2011-04-27

Start date

2011-06-10

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effect of sugammadex dose on residual neuromuscular blockade will be investigated, therefore patients suffering from various conditions undergoing surgery in general anaesthesia with muscle relaxation will be included in the study.

Interventions

Trade Name: Bridion Pharmaceutical Form: Injection INN or Proposed INN: SUGAMMADEX CAS Number: 343306-71-8 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pateint aged 18-65 undergoing general surgery in neuromuscular blockade 2. ASA (American Society of Anesthesiology) physical status score 1-3 3. BMI (Body-Mass Index) 18,5-25 4. duration of operation over 50 minutes 5. need for intratracheal intubation 6. supine position, at least one arm accessible. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. diseases influencing neuromuscular function (myopathies, significant renal or hepatic insufficiency) 2. drugs influencing neuromuscular function (magnesium, aminoglycosides) 3. gravidity 4. urgent surgery 5. chronic obstructive pulmonary disease 6. bronchial asthma 7. glaucoma

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to determine the smallest sugammadex dose, which is suitable for the effective and permanent reversal of residual rocuronium neuromuscular block.;Secondary Objective: The secondary objective of the trial is to compare the efficacy of neostigmine and sugammadex. ;Primary end point(s): Complete reversal of neuromuscular blockade (return to TOF 100% during neuromuscular monitoring). ;Timepoint(s) of evaluation of this end point: Immediately after operation.	—

Measure

Time frame

Main Objective: The main objective of the trial is to determine the smallest sugammadex dose, which is suitable for the effective and permanent reversal of residual rocuronium neuromuscular block.;Secondary Objective: The secondary objective of the trial is to compare the efficacy of neostigmine and sugammadex. ;Primary end point(s): Complete reversal of neuromuscular blockade (return to TOF 100% during neuromuscular monitoring). ;Timepoint(s) of evaluation of this end point: Immediately after operation.

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Secondary

Measure	Time frame
Secondary end point(s): No secondary end points are defined.;Timepoint(s) of evaluation of this end point: No secondary end points are defined.	—

Countries

Hungary

Contacts

Public ContactDepartmental Office

University of Debrecen, Medical and Health Science Center, Department of Anaesthesiology and Intensive Therapy

fulesdi@med.unideb.hu3652413-434

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026