A Phase 4 interventional study of Sugammadex in Postoperative Residual Curarization and Neuromuscular Block, sponsored by The Hospital of Vestfold. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by The Hospital of Vestfold · 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 3rd largest by planned enrollment, is one of 4 that started in 2018, is one of 6 in phase 4, and was the 4th registered.
98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.
Browse Delayed Emergence from Anesthesia studies →2 of the 14 studies testing sugammadex in Delayed Emergence from Anesthesia are open now, in 2 countries. Recruiting first, the newest first:
Shanghai Pulmonary Hospital, Shanghai, China · Sites in China
University Hospital, Caen · Sites in France
By country, each count listing its 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: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 144 is above the median of 83 across 58 interventional studies indexed under Delayed Emergence from Anesthesia.
Median enrollment 92 across the 14 interventional studies. Of the 9 that completed or were terminated, 1 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 14 has an industry lead sponsor. The 10 most frequent:
The Hospital of Vestfold is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
The Hospital of Vestfold 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.
This tab as a report to print or save as PDF → With an account.
Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.Recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block.
Hypotheses:
The primary objective of this trial is to assess the dose-response characteristics of sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal effective dose
Secondary objective is to assess the safety of different doses of sugammadex (recurrent block (TOF ratio \< 0.9) after reversal and the occurrence of adverse reactions)
Sugammadex is a very expensive drug which limits its use i anaesthesia department. By optimising drug dosage it may have economic impact and contribute to a wider use of sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete recovery. This may lead to less risk for postoperative pulmonary complications and thereby reduce morbidity and mortality after surgery.
Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal.
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:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo NaCl 0,9%
Drug: Sugammadex
Sugammadex 0.25 mg/kg IBW
Drug: Sugammadex
Sugammadex 0.50 mg/kg IBW
Drug: Sugammadex
Sugammadex 1.0 mg/kg IBW
Drug: Sugammadex
Sugammadex 2 mg/kg IBW
Drug: Sugammadex
Dose-response
The time from study drug administration to reaching a TOF ratio of 0.9.
Time frame: 10 minutes
Number of patient with reoccurrence of neuromuscular block after initial reversal to TOF ratio 0.9.
Time frame: 20 minutes
Number of patients with adverse reactions in each group
Adverse reactions (anaphylactic reaction, flushing, urticaria, erythematous rash, (severe) hypotension (BPsyst\> 75 mmHg), tachycardia (heart rate\> 120 beats/min), bradycardia (heart rate \<40 beats/min), swelling of tongue, swelling of pharynx, bronchospasm)
Time frame: until discharge - 3 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2018; primary completion for Dec 2019, 16 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. 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 →
The Hospital of Vestfold