TOF trial: A randomized double blinded controlled Trial comparing low dose Of sugammadex and neostigmine aFter use of rocuronium during general anesthesia in patients undergoing non-cardiac surgery

TOF trial: A randomized double blinded controlled Trial comparing low dose Of sugammadex and neostigmine aFter use of rocuronium during general anesthesia in patients undergoing non-cardiac surgery - TOF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002528-10-NO

Enrollment

224

Registered

2016-09-14

Start date

2017-07-06

Completion date

Unknown

Last updated

2025-02-24

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

Conditions

The study population will include all patients >18 years scheduled for an elective surgical procedure undergoing general anesthesia with intravenous drugs and non-depolarizing NMBA (rocuronium), with or without regional analgesia.

Interventions

Trade Name: Bridion Pharmaceutical Form: Solution for injection Trade Name: Robinul-Neostigmin Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patient undergoing any elective in-hospital surgical procedure where neuromuscular block is only needed for tracheal intubation. • ASA I-IV Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 112

Exclusion criteria

Exclusion criteria: • Patient less than 18 years of age • Patient participating in another clinical study which could interfere with TOF trial • Patient with neuromuscular disease • Patient from ICU • BMI > 30.0 kg/m2 • Patient scheduled for local or regional anesthesia only • Patient undergoing general anesthesia without rocuronium • Patient undergoing surgery that requires neuromuscular block to facilitate the procedure. • Patient with hypersensitivity to NMBAs, sugammadex or glykopyrroniumbromid-neostigmine. • Renal dysfunction (GFR<30 mL/min/1,73m2) • Patient who have received sugammadex or glykopyrroniumbromid-neostigmine in the last 24 h.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 1)Determine if TOF ratio decreases after reaching a maximum value post administration of sugammadex or neostigmine (recurarization). 2)By inclusion of sufficient number of study subjects, verify if conclusions of Pongracz et al. are correct, i.e. that most patients are adequately reversed within 5 min from time point of T4-occurrence (sugammadex 1 mg/kg), 10 min (sugammadex 0.5 mg/kg), and 15 min (neostigmine 0.05 mg/kg). ;Main Objective: The primary aim of the study is to determine cut-off values of TOF ratio above which at least 56 patients are successfully reversed with sugammadex or neostigmine within pre- determined time frames (5-15 min). ;Primary end point(s): Time needed to achieve normalized TOF ratio 1.0 after administration of reversal agent (sugammadex or neostigmine).;Timepoint(s) of evaluation of this end point: pre- determined time frames (5-15 min).	—

Measure

Time frame

Secondary Objective: 1)Determine if TOF ratio decreases after reaching a maximum value post administration of sugammadex or neostigmine (recurarization). 2)By inclusion of sufficient number of study subjects, verify if conclusions of Pongracz et al. are correct, i.e. that most patients are adequately reversed within 5 min from time point of T4-occurrence (sugammadex 1 mg/kg), 10 min (sugammadex 0.5 mg/kg), and 15 min (neostigmine 0.05 mg/kg). ;Main Objective: The primary aim of the study is to determine cut-off values of TOF ratio above which at least 56 patients are successfully reversed with sugammadex or neostigmine within pre- determined time frames (5-15 min). ;Primary end point(s): Time needed to achieve normalized TOF ratio 1.0 after administration of reversal agent (sugammadex or neostigmine).;Timepoint(s) of evaluation of this end point: pre- determined time frames (5-15 min).

—

Secondary

Measure	Time frame
Secondary end point(s): TOF-count / TOF ratio below which recurarization occurs.;Timepoint(s) of evaluation of this end point: 20 min after reversal of non-depolarizing NMBA (rocuronium)	—

Countries

Norway

Contacts

Public ContactAnesthesiology department

Vestfold Hospital Trust

tayasl@siv.no004733342000

Outcome results

None listed

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