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

INTERVENTION: Product Name: Robinul‐Neostigmin, injektionsvæske, opløsning,Product Code: PRD840883,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Glycopyrronium Bromide 0.5mg, Neostigmine Methylsulfate 2.5mg,Product Name: Bridion 100 mg/mL solution for injection,Product Code: PRD2814566,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Sugammade X100mg CONDITION: Anaesthesia to laparoscopic robotassisted surgery Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: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. Primary end point(s):Time to TOF > 0.9 (from beginning of administration of reversal agent until TOF > 0.9) Secondary Objective: SECONDARY OUTCOME: Secondary end point(s):• 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 Secondary end point(s):• 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 Secondary end point(s):• Occurrence of episodes of desaturation defined as more than 3 minutes with spO2 < 88% Secondary end point(s):• Occurrence of reintubation Secondary end point(s):• Time from administration of reversal agent to patient is ready to leave the operating room INCLUSION CRITERIA: 1) Patients = 75 years old,2) Informed consent,3) Scheduled for robotic assisted laparoscopic surgery under general anesthesia with intubation and use of rocuronium during the entire operation,4) American Society of Anesthesiologists (ASA) physical status classification I to IV,5) Can read and understand Danish