CompletedPhase 4

Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients

Denmark40 participantsStarted 2023-12-04

Plain-language summary

The aim of this study is to determine the time to TOF ≥ 0.9 after either neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg in patients with age ≥ 75 years. The hypothesis of this study is that sugammadex 2 mg/kg provides a faster time to TOF ≥ 0.9 compared to neostigmine/glycopyrrolate 50 mikrogr/kg.

Who can participate

Age range75 Years

SexALL

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Inclusion criteria

✓. Patients ≥ 75 years old
✓. Informed consent
✓. Scheduled for robotic assisted laparoscopic surgery under general anesthesia with intubation and use of rocuronium during the entire operation
✓. American Society of Anesthesiologists (ASA) physical status classification I to IV
✓. Can read and understand Danish

Exclusion criteria

✕. Known allergy to rocuronium, sugammadex or neostigmine/glycopyrrolate
✕. Neuromuscular disease that may interfere with neuromuscular data
✕. Severe renal impairment defined as eGFR \< 30 ml/min
✕. Indication for rapid sequence induction
✕. Known intestinal or ureter obstruction
✕. Known peritonitis

What they're measuring

Time to TOF > 0.9

Timeframe: first TOF ratio ≥ 0.9 (time until complete recovery from effect of muscle relaxant) followed by a stable signal with a TOF ratio ≥ 0.9 for at least two minutes.

Trial details

NCT IDNCT06228092

SponsorMatias Vested

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-04

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