Resolution of Neuromuscular BlockadeNCT02401841
Resolution of Neuro-muscular Block in Great Obese Patients: Neostigmine vs Sugammadex
An observational study of Resolution of Neuromuscular Blockade, run by Policlinico Hospital at 1 site in Italy.
Trial summary
It is a observational prospective study. The aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resolution of Neuromuscular Blockade
- What is being tested?
- Two different types of drug for resolution of neuro-muscular blockade
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Mar 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Great obese patients undergoing videolaparoscopic surgery
Who may be able to join
- Great obese
- Videolaparoscopic surgery
Who cannot join
- Age under 18
- No acceptation of informed consent
- New York Heart Association > 2
Trial locations and contacts
1 site in 1 country.
Davide Chiumello, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
Davide Chiumello, MD, +39 0255033237, chiumello@libero.it
Davide Chiumello, MD
About this study
It is a observational prospective study. The aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients.
- Conditions
- Resolution of Neuromuscular Blockade
- Being tested
- Two different types of drug for resolution of neuro-muscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two different types of drug for resolution of neuro-muscular blockadeDrug
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Patients treated with Sugammadex Receives: Drug: Two different types of drug for resolution of neuro-muscular blockade | |
| Neostigmine | Patients treated with Neostigmine Receives: Drug: Two different types of drug for resolution of neuro-muscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in neuro-muscular block resolution time between two groups
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resolution of 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401841
- Sponsor's protocol ID
- Policlinico 12
- Status last verified
- Oct 2015
- First submitted
- 18 Mar 2015
- Last updated
- 20 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resolution of Neuro-muscular Block in Great Obese Patients: Neostigmine vs Sugammadex
- ClinicalTrials.gov ID
- NCT02401841
- Acronym / sponsor ID
- Policlinico 12
- Conditions
- Resolution of Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- First posted
- 30 Mar 2015 (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.
It is a observational prospective study. The aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | – | Drug: Two different types of drug for resolution of neuro-muscular blockadePatients treated with Sugammadex |
| Neostigmine | – | Drug: Two different types of drug for resolution of neuro-muscular blockadePatients treated with Neostigmine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Great obese patients undergoing videolaparoscopic surgery
Key inclusion criteria (2 listed)
- Great obese
- Videolaparoscopic surgery
Key exclusion criteria (3 listed)
- Age under 18
- No acceptation of informed consent
- New York Heart Association > 2
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 |
|---|---|---|
| Two different types of drug for resolution of neuro-muscular blockade | Drug | Neostigmine, Sugammadex |
Primary outcome
Differences in neuro-muscular block resolution time between two groups
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.
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.
Davide Chiumello, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resolution of Neuromuscular Blockade, run by Policlinico Hospital at 1 site in Italy.
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 3 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 20 Oct 2015. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Chiumello, MD (chiumello@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in neuro-muscular block resolution time between two groups (time frame: up to 36 months). 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 20 Oct 2015.