A Phase 4 interventional study of Sugammadex in Curarization, Postoperative Residual, sponsored by University Hospital, Caen. Not yet recruiting at 1 site in France. Open to participants aged 1 Month to 24 Months. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by University Hospital, Caen · Phase 4, Interventional, and Treatment
Among 14 studies testing sugammadex in Delayed Emergence from Anesthesia — 2 open to participants now, 2 under way, none of them phase 3. Sugammadex · Delayed Emergence from Anesthesia.
Among the 14 studies testing sugammadex in Delayed Emergence from Anesthesia, this one is the 7th largest by planned enrollment, is the only one that started in 2026, is one of 6 in phase 4, and was the 14th registered.
98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.
This study's planned enrollment of 99 is above the median of 83 across 58 interventional studies indexed under Delayed Emergence from Anesthesia.
Browse Delayed Emergence from Anesthesia studies →2 of the 14 studies testing sugammadex in Delayed Emergence from Anesthesia are open now, in 2 countries. Each count lists the studies.
Sugammadex: first FDA approval 2015 (BRIDION), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →
Of the 8 Delayed Emergence from Anesthesia studies recruiting now, 2 (25%) set no upper age limit and 4 (50%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 1 Month to 24 Months · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2026.
Median enrollment 92 across the 14 interventional studies. Of the 9 that completed or were terminated, 1 (11%) have results posted.
None of the 14 has an industry lead sponsor. The 10 most frequent:
University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.
University Hospital, Caen has 1 study filed under Delayed Emergence from Anesthesia — fewer than ten, so there is no comparison to draw.
1 of the studies testing sugammadex in Delayed Emergence from Anesthesia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07477132University Hospital, CaenA Dose-response Study to Determine the Right Dosage of Sugammadex as a Reversal Agent of Rocuronium in Infants Between 1 and 24 Months Old | 2027-08-01 |
Among the 14 studies testing sugammadex in Delayed Emergence from Anesthesia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Non inclusions criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Sugammadex
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.
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).
Time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
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).
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
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).
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.
The analysis will be performed separately in the three age categories (\<6 months, 6-12 months, 12-24 months).
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.
The analysis will be performed separately in the three age categories (\<6 months, 6-12 months, 12-24 months).
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.
The analysis will be performed separately in the three age categories (\<6 months, 6-12 months, 12-24 months).
Time frame: From the arrival in the operating room to the tranfert back in the surgical ward (usually up to 12 hours)
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sugammadex
Delayed Emergence from Anesthesia →