Neuromuscular BlockadePhase 2NCT06575036
Sugammadex Dose Finding Under Two Years Old
A Phase 2 study testing Sugammadex in people with Neuromuscular Blockade, run by Sang-Hwan Ji at 1 site in South Korea.
Trial summary
This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased… Read more about this study
- Who is it for?
- Ages Up to 23 months
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2024to 31 May 2025
- Phase
- Phase 2
- 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 Up to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia
- American Society of Anesthesiologists Physical Status 1 or 2
Who cannot join
- History of hypersensitivity to rocuronium or any anesthetics
- Presence of cardiovascular or genitourinary disease
- Presence of severe renal dysfunction or in need of dialysis
- Presence of severe hepatic dysfunction or coagualtion disorder
- Current state of administration of neuromuscular blocking agent on admission to operating room
- Concurrent use of any medications that affect the activity of neuromuscular blocking agents
Show all 9Show fewer
- History of malignant hyperthermia
- Refusal to enroll in the study by one or more parents
- Presence of any other reasons that investigator regards inappropriate to enroll in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study
This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.
Read the detailed description
The investigators are planning to enroll 33 patients to obtain data. The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.
The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old.
- Conditions
- Neuromuscular Blockade
- Being tested
- Sugammadex
- Keywords
- Sugammadex, Children, Dose-finding study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Sequential determination of dose according to previous participant's result and by chance. Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% effective dose
Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients.
Measured: From start of sugammadex administration to 2 minute after end of administration
95% effective dose
Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients.
Measured: From start of sugammadex administration to 2 minute after end of administration
Secondary outcomes (4)
TOF result
Response to train-of-four stimulation after administration of sugammadex
Measured: From start of sugammadex administration to 2 minute after end of administration
Residual blockade
Incidence of recurarization in the postanesthesia care unit
Measured: From start of sugammadex administration to 24 hours after end of administration
Blood pressure
Noninvasive blood pressure after sugammadex administration measured in the operating room and postanesthesia care unit
Measured: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
Pulse oximetry
Pulse oximetry after sugammadex administration measured in the operating room and postanesthesia care unit
Measured: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start15 Sep 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Up-and-down dose finding method using biased coin design
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sang-Hwan Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sang-Hwan Ji, Seoul National University Hospital
- Investigators
- Sang-Hwan Ji, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575036
- Sponsor's protocol ID
- 2308-161-1461
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gijsenbergh F, Ramael S, Houwing N, van Iersel T. First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. Anesthesiology. 2005 Oct;103(4):695-703. doi: 10.1097/00000542-200510000-00007.
PubMed 16192761Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009.
PubMed 16571960Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.
PubMed 19194156Meibohm B, Laer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005 Oct 5;7(2):E475-87. doi: 10.1208/aapsj070248.
PubMed 16353925Olutoye OA, Yu X, Govindan K, Tjia IM, East DL, Spearman R, Garcia PJ, Coulter-Nava C, Needham J, Abrams S, Kozinetz CA, Andropoulos DB, Watcha MF. The effect of obesity on the ED(95) of propofol for loss of consciousness in children and adolescents. Anesth Analg. 2012 Jul;115(1):147-53. doi: 10.1213/ANE.0b013e318256858f. Epub 2012 May 10.
PubMed 22575569Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x.
PubMed 11890313
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study
- ClinicalTrials.gov ID
- NCT06575036
- Acronym / sponsor ID
- 2308-161-1461
- Conditions
- Neuromuscular Blockade
- Keywords
- Sugammadex, Children, Dose-finding study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sang-Hwan JiUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 28 Aug 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.
This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.
Detailed description
The investigators are planning to enroll 33 patients to obtain data. The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.
The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up-and-down dose finding method using biased coin design
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: SugammadexSequential determination of dose according to previous participant's result and by chance. |
Who may qualify
- Ages
- Up to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia
- American Society of Anesthesiologists Physical Status 1 or 2
Key exclusion criteria (9 listed)
- History of hypersensitivity to rocuronium or any anesthetics
- Presence of cardiovascular or genitourinary disease
- Presence of severe renal dysfunction or in need of dialysis
- Presence of severe hepatic dysfunction or coagualtion disorder
- Current state of administration of neuromuscular blocking agent on admission to operating room
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 |
|---|---|---|
| SugammadexAlso: BridionThe starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio. | Drug | Study group |
Primary outcome
50% effective dose
Time frame: From start of sugammadex administration to 2 minute after end of administration
Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients.
95% effective dose
Time frame: From start of sugammadex administration to 2 minute after end of administration
Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients.
4 secondary outcomes
TOF result
Time frame: From start of sugammadex administration to 2 minute after end of administration
Residual blockade
Time frame: From start of sugammadex administration to 24 hours after end of administration
Blood pressure
Time frame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
Pulse oximetry
Time frame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Background: PubMed 16192761Gijsenbergh F, Ramael S, Houwing N, van Iersel T. First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. Anesthesiology. 2005 Oct;103(4):695-703. doi: 10.1097/00000542-200510000-00007.
- Background: PubMed 16571960Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009.
- Background: PubMed 19194156Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.
- Background: PubMed 16353925Meibohm B, Laer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005 Oct 5;7(2):E475-87. doi: 10.1208/aapsj070248.
- Background: PubMed 22575569Olutoye OA, Yu X, Govindan K, Tjia IM, East DL, Spearman R, Garcia PJ, Coulter-Nava C, Needham J, Abrams S, Kozinetz CA, Andropoulos DB, Watcha MF. The effect of obesity on the ED(95) of propofol for loss of consciousness in children and adolescents. Anesth Analg. 2012 Jul;115(1):147-53. doi: 10.1213/ANE.0b013e318256858f. Epub 2012 May 10.
- Background: PubMed 11890313Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x.
- Individual participant dataSharing planned: No
Related trials for Neuromuscular Blockade
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
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.
Sang-Hwan Ji, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sugammadex in people with Neuromuscular Blockade, run by Sang-Hwan Ji at 1 site in South Korea.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Aug 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Hwan Ji, M.D., Ph.D. (+82-2-2072-3661, jsh1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% effective dose (time frame: From start of sugammadex administration to 2 minute after end of administration). The study lists 2 primary outcomes in all. 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 NCT06575036, which also lists 6 linked publications.
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 29 Aug 2024.