Neuromuscular BlockadePhase 4SUGANEONCT05718934
Low Dose of Sugammadex vs Neostigmine and Glycopyrrolate for the Reversal of Rocuronium
A Phase 4 study testing Neostigmine and glycopyrrolate and Sugammadex in people with Neuromuscular Blockade, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
The aim of this study is to compare the use of a low dose sugammadex and neostigmine combined to glycopyrrolate to reverse a rocuronium induced moderate neuromuscular blockade. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Neostigmine and glycopyrrolate and Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2022to 19 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1-3 patients,
- Undergoing general anesthesia with rocuronium induced NMB,
- TOF 1-3 at the end of surgery,
- BMI < 36 kg.m-2,
- Age > 18 years old
Who cannot join
- History of coronary artery disease and unstable before surgery
- History of serious cardiac arrhythmia (including atrial fibrillation)
- Renal or hepatic dysfunction
- Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine
- Neuromuscular disease
- Allergy to any drug used in the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Study to Compare Low Dose of Sugammadex to Standard Dose of Neostigmine and Glycopyrrolate for the Reversal of Rocuronium Induced Moderate Neuromuscular Block
The aim of this study is to compare the use of a low dose sugammadex and neostigmine combined to glycopyrrolate to reverse a rocuronium induced moderate neuromuscular blockade.
Read the detailed description
Neuromuscular blocking agents (NMBAs) are administered by anesthesiologists for general anesthesia to facilitate endotracheal intubation and/or surgical conditions. Unfortunately, postoperative residual neuromuscular blockade (rNMB), is an adverse event usually observed after extubation in the postanesthesia care unit (PACU) after surgery. rNMB is associated with upper airway obstruction, reduced pharyngeal muscle coordination, decreased functional residual capacity, and impaired hypoxic ventilatory response and may lead to critical cardiopulmonary complications.To prevent those complications, monitoring NMBAs activity as well as appropriate reversal are crucial.
In the light of the strong evidence proving the superiority of sugammadex for the reversal of NMB, the investigators chose to examine whether a quarter dose (0.5 mg.kg-1) of sugammadex would be superior to neostigmine for the reversal of moderate NMB (TOF 1 to 3). The investigators believe that this strategy will encourage the routine use of sugammadex because of a drastically reduced cost per patient with an increased safety and less adverse events compared to neostigmine reversal.
This study will be conducted in a single center, double blinded, randomized controlled study.
Type of surgery: any surgery under general anesthesia in ASA 1-3 patients, fully consented.
In the OR, the investigators will place a standardized monitoring: ECG, non-invasive blood pressure and SpO2. The investigators will monitor the depth of anesthesia using the BIS index (Medtronic, Canada) and the intraoperative nociception balance using the NOL index (Medasense Ltd., Ramat Gan, Israel). Finally, the investigators will monitor neuromuscular blockade using TOF-scan® (Draeger, Mississauga, Canada). The stimulation electrodes will be placed on the forearm of the patient to monitor the response to ulnar stimulation of the adductor pollicis muscle.
The investigators will use adjusted body weight for the administration of the drugs used in our anesthesia protocol except for rocuronium, sugammadex and neostigmine that will be given based on the real actual body weight.
The primary objective of the study:
To compare the mean time for recovery of the TOF ratio to 0.9 (90%) at the end of the surgery for rocuronium induced moderate neuromuscular blockade (TOF 1 to 3 at the end of the surgery) in two groups: Group "N" for neostigmine and group "S" for sugammadex. Group N will receive the standard reversal (neostigmine 50 µg.kg-1 and glycopyrrolate 7 µg.kg-1) and group S will receive sugammadex 0.5 mg.kg-1.
Secondary objectives are listed below.
Based on a 2-sided alpha < 0.05 and 80% power, the investigators calculated that 64 patients per group was required to detect a clinically relevant effect size of 0.5 favouring S group. The sample size will be inflated to 144 (72 per group) to account for 10% withdrawals and loss of follow-up.
Study Duration: 12 months.
Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL), University of Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
- Conditions
- Neuromuscular Blockade
- Being tested
- Neostigmine and glycopyrrolate, Sugammadex
- Keywords
- sugammadex, neostigmine, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine and glycopyrrolateDrug
See arm descriptions
SugammadexDrug
See arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| Group "N" for Standard reversal | Active comparator | Standard reversal of 50 µg.kg-1 neostigmine (up to a maximum dose of 5mg) and 7 µg.kg-1 glycopyrrolate at the end of surgery (when surgeons finish deep tissues closure) with starting TOF 1-3. Receives: Drug: Neostigmine and glycopyrrolate |
| Group "S" for Sugammadex | Experimental | Sugammadex 0.5 mg.kg-1 IV will be performed at the end of surgery (when surgeons finish deep tissues closure) with starting TOF 1-3. Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for recovery from moderate NMB
Time, in minutes, for recovery of the TOF ratio to 0.9 at the end of the surgery for rocuronium induced moderate neuromuscular blockade (TOF 1 to 3 at the end of the surgery).
Measured: Intra-operative (from T0 = incision until Tend = start dressing)
Secondary outcomes (15)
Time for awakening and extubation
The time, in minutes for awakening and extubation. Time for awakening will start at the injection of the reversal agent and end when the patient is opening his eyes. Time for extubation will start at the same time point and will end when extubation is complete.
Measured: Intra-operative (from T0 = incision until Tend = start dressing)
Incidence of reoccurrence of NMB
The incidence of rNMB (defined as TOF ratio < 0.9 30 min after the end of reversal agent administration) and the incidence of NMB reoccurrence (defined as a decrease in TOF ratio from ≥ 0.9 to < 0.8 for at least 3 consecutive TOF values)
Measured: Intra-operative (from T0 = incision until Tend = start dressing)
Incidence of critical respiratory event
The incidence of critical respiratory event (CRE). A CRE will be defined as the occurrence of one of the following criteria:
- Upper airway obstruction requiring an intervention
- Moderate hypoxemia: SpO2 of 90-93% on 2 L.min-1 nasal cannula O2 that was not improved after active interventions
- Severe hypoxemia: SpO2 < 90% on 2 L.min-1 nasal cannula O2 that was not improved after active interventions
- Signs of respiratory distress or impeding ventilatory failure
- Inability to beath deeply when requested to by a PACU nurse
- Patient complaining of symptoms of respiratory or upper airway muscle weakness
- Patient requiring reintubation in the PACU
- Clinical evidence or suspicion of pulmonary aspiration after tracheal extubation
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
Vital signs changes - Mean arterial pressure
Difference between pre-reversal values and values for mean arterial pressure (mmHg) obtained 2, 5, 10 and 30 min after reversal.
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
Vital signs changes - Heart rate
Difference between pre-reversal values and values for heart rate (bpm) obtained 2, 5, 10 and 30 min after reversal.
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
Vital signs changes - Oxygen saturation
Difference between pre-reversal values and values for SpO2 (%) obtained 2, 5, 10 and 30 min after reversal.
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
Vital signs changes - Respiratory rate
Difference between pre-reversal values and values for respiratory rate (respiration per minute) obtained 2, 5, 10 and 30 min after reversal.
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - Aldrete
Difference in Aldrete's score at rest between group and time to reach scores to discharge between groups.
5 criterias : I-Consciousness level II-Respiration III- Hemodynamics IV-Motricity V- Oxygen saturation
Minimum score : 0 Maximum score : 10
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - Maisonneuve-Rosemont PACU score
Difference in Maisonneuve-Rosemont PACU score at rest between groups and time to reach scores to discharge between groups.
8 criterias : I-Consciousness level II-Respiration III- Hemodynamics IV-Motricity V- Oxygen saturation VI- Pain VII- Nausea/Vomiting VIII- Surgical bleeding
Minimum score : 0 Maximum score : 16
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - PONV score
Difference in Postoperative nausea and vomiting (PONV) score at rest between groups and time to reach scores to discharge between groups.
0- No nausea/vomiting
- Nausea without the need of a treatment
- Nausea needing a treatment
- Nausea and vomiting
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - POSS score
Difference in Pasero Opioid-induced Sedation Scale (POSS) score at rest between groups and time to reach scores to discharge between groups.
S- Normal sleep easy awakening
- Awake and alert
- Sometimes drowsy, easy awakening
- Drowsy, wakes up but falls asleep during conversation
- Sleeps soundly, wakes up with difficulty or not at all to stimulation
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - NRS pain score
Difference in Nnumeric Rating Scale (NRS) pain score at rest between groups and time to reach scores to discharge between groups.
Scale between 0 meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
Time spent in PACU
Total time, in minutes spent in PACU
Measured: Every 15 minutes until discharge from PACU, up to 2 hours
Cost of reversal agent
Cost, in CAD, associated with reversal agent
Measured: Intra-operative (from T0 = incision until Tend = start dressing)
Overall cost
Cost evaluation, in CAD, associated with extubation time in the operating room and PACU stay.
Measured: Intra-operative (from T0 = incision until Tend = start dressing) to PACU discharge, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start8 Nov 2022
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
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 BlockadeStudies 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
- Two groups of patients randomized into Group "N" for neostigmine and group "S" for sugammadex for a total of 144 participants.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe PR Richebé, MD PhD, Principal investigator, CIUSSS Est de l'île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718934
- Sponsor's protocol ID
- 2023-3091
- Acronym
- SUGANEO
- Status last verified
- Feb 2024
- First submitted
- 1 Nov 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hadj-Mimoune S, Morisson L, Ellassraoui S, Idrissi M, Quach M, Godin N, Oulehri W, Fortier LP, Verdonck O, Laferriere-Langlois P, Richebe P. Low dose of sugammadex versus neostigmine for reversal of rocuronium induced moderate neuromuscular block: a randomized controlled trial. BMC Anesthesiol. 2026 Jan 17;26(1):113. doi: 10.1186/s12871-025-03581-2.
PubMed 41545820
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study to Compare Low Dose of Sugammadex to Standard Dose of Neostigmine and Glycopyrrolate for the Reversal of Rocuronium Induced Moderate Neuromuscular Block
- ClinicalTrials.gov ID
- NCT05718934
- Acronym / sponsor ID
- SUGANEO / 2023-3091
- Conditions
- Neuromuscular Blockade
- Keywords
- sugammadex, neostigmine, general anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 8 Feb 2023 (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 compare the use of a low dose sugammadex and neostigmine combined to glycopyrrolate to reverse a rocuronium induced moderate neuromuscular blockade.
Detailed description
Neuromuscular blocking agents (NMBAs) are administered by anesthesiologists for general anesthesia to facilitate endotracheal intubation and/or surgical conditions. Unfortunately, postoperative residual neuromuscular blockade (rNMB), is an adverse event usually observed after extubation in the postanesthesia care unit (PACU) after surgery. rNMB is associated with upper airway obstruction, reduced pharyngeal muscle coordination, decreased functional residual capacity, and impaired hypoxic ventilatory response and may lead to critical cardiopulmonary complications.To prevent those complications, monitoring NMBAs activity as well as appropriate reversal are crucial.
In the light of the strong evidence proving the superiority of sugammadex for the reversal of NMB, the investigators chose to examine whether a quarter dose (0.5 mg.kg-1) of sugammadex would be superior to neostigmine for the reversal of moderate NMB (TOF 1 to 3). The investigators believe that this strategy will encourage the routine use of sugammadex because of a drastically reduced cost per patient with an increased safety and less adverse events compared to neostigmine reversal.
This study will be conducted in a single center, double blinded, randomized controlled study.
Type of surgery: any surgery under general anesthesia in ASA 1-3 patients, fully consented.
In the OR, the investigators will place a standardized monitoring: ECG, non-invasive blood pressure and SpO2. The investigators will monitor the depth of anesthesia using the BIS index (Medtronic, Canada) and the intraoperative nociception balance using the NOL index (Medasense Ltd., Ramat Gan, Israel). Finally, the investigators will monitor neuromuscular blockade using TOF-scan® (Draeger, Mississauga, Canada). The stimulation electrodes will be placed on the forearm of the patient to monitor the response to ulnar stimulation of the adductor pollicis muscle.
The investigators will use adjusted body weight for the administration of the drugs used in our anesthesia protocol except for rocuronium, sugammadex and neostigmine that will be given based on the real actual body weight.
The primary objective of the study:
To compare the mean time for recovery of the TOF ratio to 0.9 (90%) at the end of the surgery for rocuronium induced moderate neuromuscular blockade (TOF 1 to 3 at the end of the surgery) in two groups: Group "N" for neostigmine and group "S" for sugammadex. Group N will receive the standard reversal (neostigmine 50 µg.kg-1 and glycopyrrolate 7 µg.kg-1) and group S will receive sugammadex 0.5 mg.kg-1.
Secondary objectives are listed below.
Based on a 2-sided alpha < 0.05 and 80% power, the investigators calculated that 64 patients per group was required to detect a clinically relevant effect size of 0.5 favouring S group. The sample size will be inflated to 144 (72 per group) to account for 10% withdrawals and loss of follow-up.
Study Duration: 12 months.
Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL), University of Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of patients randomized into Group "N" for neostigmine and group "S" for sugammadex for a total of 144 participants.
| Arm | Type | Receives |
|---|---|---|
| Group "N" for Standard reversal | Active comparator | Drug: Neostigmine and glycopyrrolateStandard reversal of 50 µg.kg-1 neostigmine (up to a maximum dose of 5mg) and 7 µg.kg-1 glycopyrrolate at the end of surgery (when surgeons finish deep tissues closure) with starting TOF 1-3. |
| Group "S" for Sugammadex | Experimental | Drug: SugammadexSugammadex 0.5 mg.kg-1 IV will be performed at the end of surgery (when surgeons finish deep tissues closure) with starting TOF 1-3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA 1-3 patients,
- Undergoing general anesthesia with rocuronium induced NMB,
- TOF 1-3 at the end of surgery,
- BMI < 36 kg.m-2,
- Age > 18 years old
Key exclusion criteria (6 listed)
- History of coronary artery disease and unstable before surgery
- History of serious cardiac arrhythmia (including atrial fibrillation)
- Renal or hepatic dysfunction
- Obstructive sleep apnea requiring continuous positive airway pressure (CPAP) machine
- Neuromuscular disease
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 and glycopyrrolateSee arm descriptions | Drug | Group "N" for Standard reversal |
| SugammadexSee arm descriptions | Drug | Group "S" for Sugammadex |
Primary outcome
Time for recovery from moderate NMB
Time frame: Intra-operative (from T0 = incision until Tend = start dressing)
Time, in minutes, for recovery of the TOF ratio to 0.9 at the end of the surgery for rocuronium induced moderate neuromuscular blockade (TOF 1 to 3 at the end of the surgery).
15 secondary outcomes
Time for awakening and extubation
Time frame: Intra-operative (from T0 = incision until Tend = start dressing)
Incidence of reoccurrence of NMB
Time frame: Intra-operative (from T0 = incision until Tend = start dressing)
Incidence of critical respiratory event
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
Vital signs changes - Mean arterial pressure
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
Vital signs changes - Heart rate
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
Vital signs changes - Oxygen saturation
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
Vital signs changes - Respiratory rate
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - Aldrete
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - Maisonneuve-Rosemont PACU score
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - PONV score
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - POSS score
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
PACU scores - NRS pain score
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
Time spent in PACU
Time frame: Every 15 minutes until discharge from PACU, up to 2 hours
Cost of reversal agent
Time frame: Intra-operative (from T0 = incision until Tend = start dressing)
Overall cost
Time frame: Intra-operative (from T0 = incision until Tend = start dressing) to PACU discharge, up to 2 hours
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 20 Feb 2024.
- Derived from this study: PubMed 41545820Hadj-Mimoune S, Morisson L, Ellassraoui S, Idrissi M, Quach M, Godin N, Oulehri W, Fortier LP, Verdonck O, Laferriere-Langlois P, Richebe P. Low dose of sugammadex versus neostigmine for reversal of rocuronium induced moderate neuromuscular block: a randomized controlled trial. BMC Anesthesiol. 2026 Jan 17;26(1):113. doi: 10.1186/s12871-025-03581-2.
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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.
Philippe PR Richebé, MD PhD principal investigator
CIUSSS Est de l'île de Montréal
1 site 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 and glycopyrrolate and Sugammadex in people with Neuromuscular Blockade, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 for recovery from moderate NMB (time frame: Intra-operative (from T0 = incision until Tend = start dressing)). 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 NCT05718934, 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 20 Feb 2024.