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

NCT06228092 | Completed Phase 4 DMC

• 1 other identifier: 2023-504230-21-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Neuromuscular Blockade, Residual

Outcome Measures

Primary Outcomes (1)

• Time to TOF > 0.9

  time to TOF ≥ 0.9 after administration of either sugammadex or neostigmine/glycopyrrolate

  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.

Secondary Outcomes (1)

• Residual muscular blockade

  Assessed upon arrival at PACU, after 20 minutes at PACU and after 90 minutes at PACU

Other Outcomes (4)

• Episodes of desaturation

  During the period of the PACU stay

• New cardiac arrythmias

  Within 180 minutes after administration of reversal agent

• Airway obstruction

  During the period of the PACU stay

Study Arms (2)

neostigmine/glycopyrrolate group

ACTIVE COMPARATOR

neostigmine/glycopyrrolate 50 mikrogr/kg

Drug: neostigmine/glycopyrrolate

Sugammadex group

ACTIVE COMPARATOR

Sugammadex 2 mg/kg

Drug: Sugammadex

Interventions

neostigmine/glycopyrrolate DRUG

Anesthesia personnel will administer the drug as a bolus over 5 seconds in an intravenous catheter upon conclusion of anaesthesia with a TOF within the range from TOF count of 2 to a TOF ratio \< 0.60

Also known as: Robinul-Neostigmin

neostigmine/glycopyrrolate group

Sugammadex DRUG

Anesthesia personnel will administer the drug as a bolus over 5 seconds in an intravenous catheter upon conclusion of anaesthesia with a TOF within the range from TOF count of 2 to a TOF ratio \< 0.60

Also known as: Bridion

Sugammadex group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matias Vested: lead

Study Sites (3)

Department of anaesthesia, Centre of Head and Orthopedics, Rigshospitalet

Copenhagen, 2830, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Department of Pediatric and Obstetric Anaesthesia, Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• Vested M, Wadland SS, Christensen MI, Creutzburg A, Madsen KPD, Tsuchiya EA, Madsen BG, Rovsing ML, Meyhoff CS, Lindelof K, Afshari A, Rasmussen LS. Neostigmine Versus Sugammadex for Reversal of Neuromuscular Blockade in Elderly Patients: A Blinded Randomised Study. Acta Anaesthesiol Scand. 2026 Jan;70(1):e70160. doi: 10.1111/aas.70160.

  PMID: 41307280 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Neostigmine; Glycopyrrolate; Sugammadex

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Matias Vested, MD, PhD

  Rigshospitalet University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Ph.D.

Model Details: Randomized study

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: January 29, 2024
• Study Start: December 4, 2023
• Primary Completion: May 4, 2025
• Study Completion: May 4, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)