Neuromuscular Blockade, ResidualPhase 4NCT06228092
Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients
A Phase 4 study testing neostigmine/glycopyrrolate and Sugammadex in people with Neuromuscular Blockade, Residual, run by Matias Vested at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Neuromuscular Blockade, Residual
- What is being tested?
- neostigmine/glycopyrrolate and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesDenmark
- Study dates
- 4 Dec 2023to 4 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of anaesthesia, Centre of Head and Orthopedics, Rigshospitalet
Copenhagen, 2830
Bispebjerg Hospital
Copenhagen
Department of Pediatric and Obstetric Anaesthesia, Rigshospitalet
Copenhagen
About this study
Official title: A Blinded Randomized Study of Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients (≥ 75 Years)
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.
Read the detailed description
Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications.
Although the use of neuromuscular blocking agents (NMBAs) to improve surgical condition are still debated, they are routinely administered in the clinical setting during anesthesia both to facilitate tracheal intubation and impair the surgical conditions. However, elderly patients administered NMBAs during anesthesia have an increased risk of postoperative residual neuromuscular block which is associated with more frequent episodes of hypoxemia, postoperative pulmonary complications, discomfort and longer hospital length of stay.
To prevent postoperative residual block it is strongly recommended to employ neuromuscular monitoring perioperatively, performed by train-of-four (TOF) stimulation, which enables the anesthetist to titrate the depth of block and to reverse the block if spontaneous recovery has not occurred upon conclusion of surgery.
It is possible to reverse rocuronium induced neuromuscular blockade with either neostigmine/glycopyrrolate (an acetylcholine esterase inhibitor) or sugammadex (a modified cyclodextrin). However, the optimal choice of reversal agent for rocuronium induced neuromuscular blockade in elderly patients is unknown. There is a need for studies investigating which reversal agent is optimal in elderly patients.
This randomized, parallel group trial will compare neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg for reversal of rocuronium induced blockade in elderly patients (≥ 75 years) undergoing robot surgery.
- Conditions
- Neuromuscular Blockade, Residual
- Being tested
- neostigmine/glycopyrrolate, Sugammadex
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neostigmine/glycopyrrolateDrug
Also called Robinul-Neostigmin
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
SugammadexDrug
Also called Bridion
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
| Study group | Role | What they receive |
|---|---|---|
| neostigmine/glycopyrrolate group | Active comparator | neostigmine/glycopyrrolate 50 mikrogr/kg Receives: Drug: neostigmine/glycopyrrolate |
| Sugammadex group | Active comparator | Sugammadex 2 mg/kg Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to TOF > 0.9
time to TOF ≥ 0.9 after administration of either sugammadex or neostigmine/glycopyrrolate
Measured: 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
Sign of residual muscular blockade defined as a composite (assessed upon arrival at PACU) of either:
hand grip strength for 5 seconds; occurrence of double vision/blurred vision (yes/no); ability to track objects with eyes (follow finger of examiner) (yes/no); ability to sustain head lift for 5 seconds (yes/no); ability to protrude the tongue for 5 seconds (yes/no); tongue depressor test (prevent removal of a wooden tongue depressor from between the incisor teeth (yes/no); ability to open the eyes for 5 seconds (yes/no); ability to smile (yes/no); ability to speak (yes/no); occurrence of dysphagia/ swallowing impairment (ability to drink 20 ml of water) (yes/no); occurrence of upper airway obstruction; subjective symptoms of muscle weakness (whether the patient think a test was difficult to complete or uncomfortable to perform), recorded as normal (negative response) or impaired (positive response)
Measured: Assessed upon arrival at PACU, after 20 minutes at PACU and after 90 minutes at PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start4 Dec 2023
- Primary completion4 May 2025
- Study completion4 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Blockade, ResidualStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matias Vested
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matias Vested, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Matias Vested, MD, PhD, Study chair, Rigshospitalet University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228092
- Sponsor's protocol ID
- 2023-504230-21-00
- Other IDs
- 2023
- Status last verified
- Aug 2025
- First submitted
- 3 Nov 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41307280
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded Randomized Study of Neostigmine/Glyco-pyrrolate 50 Mikrogram/kg or Sugammadex 2 mg/kg for Reversal of Neuromuscular Blockade in Elderly Patients (≥ 75 Years)
- ClinicalTrials.gov ID
- NCT06228092
- Acronym / sponsor ID
- 2023-504230-21-00
- Conditions
- Neuromuscular Blockade, Residual
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Matias VestedUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 4 May 2025 (actual)
- Study completion
- 4 May 2025 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications.
Although the use of neuromuscular blocking agents (NMBAs) to improve surgical condition are still debated, they are routinely administered in the clinical setting during anesthesia both to facilitate tracheal intubation and impair the surgical conditions. However, elderly patients administered NMBAs during anesthesia have an increased risk of postoperative residual neuromuscular block which is associated with more frequent episodes of hypoxemia, postoperative pulmonary complications, discomfort and longer hospital length of stay.
To prevent postoperative residual block it is strongly recommended to employ neuromuscular monitoring perioperatively, performed by train-of-four (TOF) stimulation, which enables the anesthetist to titrate the depth of block and to reverse the block if spontaneous recovery has not occurred upon conclusion of surgery.
It is possible to reverse rocuronium induced neuromuscular blockade with either neostigmine/glycopyrrolate (an acetylcholine esterase inhibitor) or sugammadex (a modified cyclodextrin). However, the optimal choice of reversal agent for rocuronium induced neuromuscular blockade in elderly patients is unknown. There is a need for studies investigating which reversal agent is optimal in elderly patients.
This randomized, parallel group trial will compare neostigmine/glycopyrrolate 50 mikrogr/kg or sugammadex 2 mg/kg for reversal of rocuronium induced blockade in elderly patients (≥ 75 years) undergoing robot surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized study
| Arm | Type | Receives |
|---|---|---|
| neostigmine/glycopyrrolate group | Active comparator | Drug: neostigmine/glycopyrrolateneostigmine/glycopyrrolate 50 mikrogr/kg |
| Sugammadex group | Active comparator | Drug: SugammadexSugammadex 2 mg/kg |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neostigmine/glycopyrrolateAlso: Robinul-NeostigminAnesthesia 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 | Drug | neostigmine/glycopyrrolate group |
| SugammadexAlso: BridionAnesthesia 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 | Drug | Sugammadex group |
Primary outcome
Time to TOF > 0.9
Time frame: 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.
time to TOF ≥ 0.9 after administration of either sugammadex or neostigmine/glycopyrrolate
1 secondary outcome
Residual muscular blockade
Time frame: Assessed upon arrival at PACU, after 20 minutes at PACU and after 90 minutes at PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Derived from this study: PubMed 41307280Vested 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.
- Individual participant dataSharing planned: No
Related trials for Neuromuscular Blockade, Residual
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
Postoperative Residual Curarization, Neuromuscular Block Prolonged
Not yet recruitingObservational study
Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
Neuromuscular Blockade, Cholecystectomy
Recruiting
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
Residual Neuromuscular Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matias Vested, MD, PhD study chair
Rigshospitalet University of Copenhagen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing neostigmine/glycopyrrolate and Sugammadex in people with Neuromuscular Blockade, Residual, run by Matias Vested at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to TOF > 0.9 (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.