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A blinded randomized study of neostigmine/glycopyrrolate 50 mikrogram/kg or sugammadex 2 mg/kg for reversal of neuromuscular blockade in elderly patients (≥ 75 years)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504230-21-00
Enrollment
1
Registered
2023-06-07
Start date
2024-08-12
Completion date
2025-05-04
Last updated
2025-03-12

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

Conditions

Anaesthesia to laparoscopic robotassisted surgery

Brief summary

Time to TOF > 0.9 (from beginning of administration of reversal agent until TOF > 0.9)

Detailed description

• Key secondary outcome is sign of residual neuromuscular blockade within 90 minutes after administration of reversal agent defined as a composite (assessed upon arrival at PACU after 20 minutes and after 90 minutes) of either o Hand grip strength for 5 seconds or o Occurrence of double vision/blurred vision (yes/no) or o Ability to track objects with eyes (follow finger of examiner) (yes/no) or o Ability to sustain head lift for 5 seconds (yes/no) or o Ability to protrude the tongue for 5 seco, • Occurrence of episodes of desaturation defined as more than 3 minutes with spO2 < 88%, • New cardiac arrythmias (bradycardia or tachycardia defined as atrial fibrillation, atrial flutter, sinus tachycardia (>95 bpm), sinus bradycardia (<45 bpm)) within 180 minutes after administration of reversal agent, • Occurrence of reintubation, • Time from administration of reversal agent to patient is ready to leave the operating room

Interventions

DRUGRobinul-Neostigmin
DRUGinjektionsvæske
DRUGopløsning
DRUGBridion 100 mg/mL solution for injection

Sponsors

Rigshospitalet, Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to TOF > 0.9 (from beginning of administration of reversal agent until TOF > 0.9)

Secondary

MeasureTime frame
• Key secondary outcome is sign of residual neuromuscular blockade within 90 minutes after administration of reversal agent defined as a composite (assessed upon arrival at PACU after 20 minutes and after 90 minutes) of either o Hand grip strength for 5 seconds or o Occurrence of double vision/blurred vision (yes/no) or o Ability to track objects with eyes (follow finger of examiner) (yes/no) or o Ability to sustain head lift for 5 seconds (yes/no) or o Ability to protrude the tongue for 5 seco, • Occurrence of episodes of desaturation defined as more than 3 minutes with spO2 < 88%, • New cardiac arrythmias (bradycardia or tachycardia defined as atrial fibrillation, atrial flutter, sinus tachycardia (>95 bpm), sinus bradycardia (<45 bpm)) within 180 minutes after administration of reversal agent, • Occurrence of reintubation, • Time from administration of reversal agent to patient is ready to leave the operating room

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026