Anesthesia Recovery Period, Neuromuscular BlockadeNCT01890057
The Dose of Sugammadex for Rapid Reversal of Profound Neuromuscular Block in Young and Elderly Patients
A study testing Sugammadex in people with Anesthesia Recovery Period, Neuromuscular Blockade, run by Severance Hospital at 1 site in South Korea.
Trial summary
To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound rocuronium-induced neuromuscular block in young and elderly adult patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anesthesia Recovery Period, Neuromuscular Blockade
- What is being tested?
- Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Jan 2014
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-40 years or ≥70 years ASA class I-II patients who received surgery less than 2 hours.
Who cannot join
- anticipated difficult intubation
- neuromuscular, hepatic or renal disorders
- drug allergy
- body mass index >30 kg/m2 or body mass index <18 kg/m2
- emergency surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul
About this study
To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound rocuronium-induced neuromuscular block in young and elderly adult patients.
Read the detailed description
A previous study reported that elderly patients required a longer time to recover from rocuronium induced neuromuscular block compared to younger patients. Therefore, the aim of this study is to find out the dose of sugammadex for rapid recovery from profound neuromuscular block in young and elderly adult patients.
- Being tested
- Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
The dose of sugammadex
| Study group | Role | What they receive |
|---|---|---|
| Young adults | Experimental | To find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method Receives: Drug: Sugammadex |
| Elderly adults | Experimental | To find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Recovery Period, 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890057
- Sponsor's protocol ID
- 4-2013-0280
- Status last verified
- Feb 2014
- First submitted
- 26 Jun 2013
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose of Sugammadex for Rapid Reversal of Profound Neuromuscular Block in Young and Elderly Patients
- ClinicalTrials.gov ID
- NCT01890057
- Acronym / sponsor ID
- 4-2013-0280
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Jul 2013 (estimated)
- 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.
To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound rocuronium-induced neuromuscular block in young and elderly adult patients.
Detailed description
A previous study reported that elderly patients required a longer time to recover from rocuronium induced neuromuscular block compared to younger patients. Therefore, the aim of this study is to find out the dose of sugammadex for rapid recovery from profound neuromuscular block in young and elderly adult patients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young adults | Experimental | Drug: SugammadexTo find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method |
| Elderly adults | Experimental | Drug: SugammadexTo find out the the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block : Dixon's up-and-down method |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20-40 years or ≥70 years ASA class I-II patients who received surgery less than 2 hours.
Key exclusion criteria (5 listed)
- anticipated difficult intubation
- neuromuscular, hepatic or renal disorders
- drug allergy
- body mass index >30 kg/m2 or body mass index <18 kg/m2
- emergency surgery
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 |
|---|---|---|
| SugammadexThe dose of sugammadex | Drug | Elderly adults, Young adults |
Primary outcome
The dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block
Time frame: 2 hour
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 4 Feb 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex in people with Anesthesia Recovery Period, Neuromuscular Blockade, run by Severance Hospital 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 1 inclusion and 5 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 4 Feb 2014. 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.
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?
The dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound neuromuscular block (time frame: 2 hour). 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 4 Feb 2014.