Curarization, Postoperative ResidualPhase 4SUGAPEDIANCT07477132
A Dose-response Study to Determine the Right Dosage of Sugammadex as a Reversal Agent of Rocuronium in Infants Between 1 and 24 Months Old
A Phase 4 study testing Sugammadex in people with Curarization, Postoperative Residual, run by University Hospital, Caen at 1 site in France.
Trial summary
Sugammadex is a drug used more and more frequently in infants as a rocuronium' s reversal agent. It has multiples benefits over other reversal agents such as a rapid onset of action and a complete reversal no matter how deep is the neuromuscular blockade. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Curarization, Postoperative Residual
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2026to 1 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child, male or female, aged < 24 months.
- American Society of Anesthesiologists (ASA) Physical Status Class I or II.
- Non-cardiac and non-emergency surgical procedure, or relative emergency (>12 h) requiring neuromuscular blockade with rocuronium and reversal with sugammadex.
- Surgical procedure allowing neuromuscular monitoring at the adductor pollicis muscle.
- Child covered by a social security regiment.
- Written informed consent signed by the holder(s) of parental authority.
- French-speaking holder(s) of parental authority.
Who cannot join
- Child who received or will receive toremifene or fusidic acid within 24 hours before or after administration of the study treatments (rocuronium, sugammadex).
- Use of two different neuromuscular blocking agents during the procedure.
- Failure to calibrate the Train-of-Four (TOF) qualitative count (TOFc) and quantitative ratio (TOFr).
- Non-compliance with the titrated administration protocol of sugammadex and TOF monitoring during the study.
- Use, during the procedure, of medications that may interfere with the study treatments: aminoglycosides, lincosamides, polymyxins, quinidine, quinine, magnesium salts, phenytoin, carbamazepine, or continuous IV lidocaine.
- Non inclusions criteria :
Show all 15Show fewer
- Emergency requiring care in the operating room within < 12 hours.
- Child weighing more than 20 kg.
- Premature child: < 37 weeks gestational age at birth.
- Suspected or diagnosed neuromuscular disorder at the time of surgical care.
- Child suspected of having,or with a family history of, malignant hyperthermia.
- Child suspected of having, or with a known allergy to, the medications used in the study (rocuronium, sugammadex) or any of their respective excipients.
- Child expected to require mechanical ventilation at the end of the surgical procedure.
- Child receiving, at the time of inclusion, regular treatment with medications that may interfere with the treatments used in this study: aminoglycosides, lincosamides, polymyxins, quinidine, quinine, magnesium salts, phenytoin, carbamazepine.
- Minor holders of parental authority, or children under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier universitaire Caen Normandie
Caen, 14000
Jean-Philippe SALAÜN, MD, +33 2 31 06 57 81, salaun-jp@chu-caen.fr
Jean-Philippe SALAÜN, MD
About this study
Official title: Study to Determine the Dosage of Sugammadex as a Rocuronium Reversal's Agent in Infants Younger Than 24 Months Old
Sugammadex is a drug used more and more frequently in infants as a rocuronium' s reversal agent. It has multiples benefits over other reversal agents such as a rapid onset of action and a complete reversal no matter how deep is the neuromuscular blockade.
The dosage of sugammadex used in current clinical practice is the same as in adults based on empirical evidence. Futhermore some multricentric studies showed that that dosage might not be appropriate for infants younger than 2 years old.
The goal of this study is to determine the correct dosage of sugammadex to use in infants younger than 2 years old.
- Conditions
- Curarization, Postoperative Residual
- Being tested
- Sugammadex
- Keywords
- Neuromuscular blocking agent, children, curarization
- 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.
SugammadexDrug
Sugammadex titration as an antagonist agent of rocuronium in infants < 24 months old undergoing surgery.
In post anesthesia care room 0.2mg/kg of sugammadex will be administered every 3 +/-1 min while monitoring the residual neuromuscular blockade with an EMG based device.
| Study group | Role | What they receive |
|---|---|---|
| Infants < 24 months old | Experimental | Not described Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dosage of sugammadex necessary to obtain a complete reversal of neuromuscular blockade.
The total dosage is obtained by adding each titration dosage of 0.2mg/kg every 3 +/-1 min to obtain a TOF ration of > 90%.
The analysis will be conducted in three age categories (<6 months, 6-12 months, 12-24 months) and according to the depth of neuromuscular blockade before reversal (TOF count < 2/4 and TOF count ≥ 2/4).
Measured: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Secondary outcomes (5)
Compare among the three age groups (<6 months, 6-12 months, 12-24 months): the doses of sugammadex required to achieve complete reversal of neuromuscular blockade, the percentage of subjects for whom the required dose was lower than the recommended dose
The analysis will be performed separately in the three age categories (<6 months, 6-12 months, 12-24 months).
Measured: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Detect the possible occurrence of electrical or clinical recurarization phenomena during the reversal procedure in children under 24 months of age, and evaluate their association with different parameters
Detect the possible occurrence of electrical or clinical recurarization phenomena during the reversal procedure in children under 24 months of age, and evaluate their association with: the initial depth of neuromuscular blockade, the total dose of rocuronium administered, and the time interval between the last dose of rocuronium and the first dose of sugammadex.
The analysis will be performed separately in the three age categories (<6 months, 6-12 months, 12-24 months).
Measured: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Describe, in all three patient group, the temporal evolution of the depth of neuromuscular blockade during the reversal procedure.
The analysis will be performed separately in the three age categories (<6 months, 6-12 months, 12-24 months).
Measured: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Determine the incidence of recurarization (defined as the reappearance of neuromuscular blockade after a fully documented complete reversal) within 60 minutes following sugammadex-induced reversal in children under 24 months of age.
The analysis will be performed separately in the three age categories (<6 months, 6-12 months, 12-24 months).
Measured: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Identify adverse events related to the administration of sugammadex, such as recurarization or drug hypersensitivity.
The analysis will be performed separately in the three age categories (<6 months, 6-12 months, 12-24 months).
Measured: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Curarization, Postoperative 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477132
- Sponsor's protocol ID
- 25-0035
- Other IDs
- 2025-521946-82-00, 2025
- Acronym
- SUGAPEDIA
- Status last verified
- Dec 2025
- First submitted
- 5 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Dosage of Sugammadex as a Rocuronium Reversal's Agent in Infants Younger Than 24 Months Old
- ClinicalTrials.gov ID
- NCT07477132
- Acronym / sponsor ID
- SUGAPEDIA / 25-0035
- Conditions
- Curarization, Postoperative Residual
- Keywords
- Neuromuscular blocking agent, children, curarization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Mar 2026 (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.
Sugammadex is a drug used more and more frequently in infants as a rocuronium' s reversal agent. It has multiples benefits over other reversal agents such as a rapid onset of action and a complete reversal no matter how deep is the neuromuscular blockade.
The dosage of sugammadex used in current clinical practice is the same as in adults based on empirical evidence. Futhermore some multricentric studies showed that that dosage might not be appropriate for infants younger than 2 years old.
The goal of this study is to determine the correct dosage of sugammadex to use in infants younger than 2 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants < 24 months old | Experimental | Drug: Sugammadex |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child, male or female, aged < 24 months.
- American Society of Anesthesiologists (ASA) Physical Status Class I or II.
- Non-cardiac and non-emergency surgical procedure, or relative emergency (>12 h) requiring neuromuscular blockade with rocuronium and reversal with sugammadex.
- Surgical procedure allowing neuromuscular monitoring at the adductor pollicis muscle.
- Child covered by a social security regiment.
Key exclusion criteria (15 listed)
- Child who received or will receive toremifene or fusidic acid within 24 hours before or after administration of the study treatments (rocuronium, sugammadex).
- Use of two different neuromuscular blocking agents during the procedure.
- Failure to calibrate the Train-of-Four (TOF) qualitative count (TOFc) and quantitative ratio (TOFr).
- Non-compliance with the titrated administration protocol of sugammadex and TOF monitoring during the study.
- Use, during the procedure, of medications that may interfere with the study treatments: aminoglycosides, lincosamides, polymyxins, quinidine, quinine, magnesium salts, phenytoin, carbamazepine, or continuous IV lidocaine.
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 |
|---|---|---|
| SugammadexSugammadex titration as an antagonist agent of rocuronium in infants < 24 months old undergoing surgery. In post anesthesia care room 0.2mg/kg of sugammadex will be administered every 3 +/-1 min while monitoring the residual neuromuscular blockade with an EMG based device. | Drug | Infants < 24 months old |
Primary outcome
Total dosage of sugammadex necessary to obtain a complete reversal of neuromuscular blockade.
Time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
The total dosage is obtained by adding each titration dosage of 0.2mg/kg every 3 +/-1 min to obtain a TOF ration of > 90%. The analysis will be conducted in three age categories (<6 months, 6-12 months, 12-24 months) and according to the depth of neuromuscular blockade before reversal (TOF count < 2/4 and TOF count ≥ 2/4).
5 secondary outcomes
Compare among the three age groups (<6 months, 6-12 months, 12-24 months): the doses of sugammadex required to achieve complete reversal of neuromuscular blockade, the percentage of subjects for whom the required dose was lower than the recommended dose
Time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Detect the possible occurrence of electrical or clinical recurarization phenomena during the reversal procedure in children under 24 months of age, and evaluate their association with different parameters
Time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Describe, in all three patient group, the temporal evolution of the depth of neuromuscular blockade during the reversal procedure.
Time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Determine the incidence of recurarization (defined as the reappearance of neuromuscular blockade after a fully documented complete reversal) within 60 minutes following sugammadex-induced reversal in children under 24 months of age.
Time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Identify adverse events related to the administration of sugammadex, such as recurarization or drug hypersensitivity.
Time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Sugammadex in people with Curarization, Postoperative Residual, run by University Hospital, Caen at 1 site in France.
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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 17 Mar 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dosage of sugammadex necessary to obtain a complete reversal of neuromuscular blockade. (time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.