Anesthesiology ManagementPhase 4NCT03144453
Recovery From Anesthesia After Robotic Assisted Radical Cystectomy
A Phase 4 study testing Sugammadex Injectable Product and Neostigmine, Atropine in people with Anesthesiology Management, run by Regina Elena Cancer Institute at 2 sites in Italy.
Trial summary
Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the final stages of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesiology Management
- What is being tested?
- Sugammadex Injectable Product and Neostigmine, Atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 2 May 2017to Dec 2019
- Phase
- Phase 4
- 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
Who may be able to join
- ASA (american society of anesthesiologists) score ≤ III
- Patients underwent robotic assisted cystectomy
Who cannot join
- Cerebrovascular disease
- BMI (body mass index) ≥ 30
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Ester Forastiere
Rome, RM, 00144
Ester Forastiere, Chief, 00390652662994, ester.forastiere@ifo.gov.it
- Recruiting
Regina Elena Cancer Institute
Rome, RM, 00144
Forastiere Ester, 00390652662994, forastiere@ifo.it
Claudia Claroni, MD
About this study
Official title: Recovery From Anesthesia After Robotic Assisted Radical Cystectomy. Two Different Reversal of Neuromuscular Blockade
Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the final stages of surgery. The aim of this study was to evaluate the quality of awakening in two groups of patients undergoing different combinations of curarization/reversal.
- Conditions
- Anesthesiology Management
- Being tested
- Sugammadex Injectable Product, Neostigmine, Atropine
- Keywords
- Curare, Robotic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex Injectable ProductDrug
Patients receive sugammadex at the end of the surgery
Neostigmine, AtropineDrug
Patients receive neostigmine+atropine at the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | The patients received sugammadex as neuromuscular blockade reversal Receives: Drug: Sugammadex Injectable Product |
| Standard | Active comparator | The patients received neostigmine + atropine as neuromuscular blockade reversal Receives: Drug: Neostigmine, Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge from recovery room
Time between reversal administration and discharge from the recovery room
Measured: Up to 240 Minutes After recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start2 May 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesiology ManagementStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144453
- Sponsor's protocol ID
- CE/2288
- Status last verified
- Jan 2019
- First submitted
- 3 May 2017
- Last updated
- 28 Jan 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery From Anesthesia After Robotic Assisted Radical Cystectomy. Two Different Reversal of Neuromuscular Blockade
- ClinicalTrials.gov ID
- NCT03144453
- Acronym / sponsor ID
- CE/2288
- Conditions
- Anesthesiology Management
- Keywords
- Curare, Robotic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 May 2017 (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.
Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the final stages of surgery. The aim of this study was to evaluate the quality of awakening in two groups of patients undergoing different combinations of curarization/reversal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Experimental | Drug: Sugammadex Injectable ProductThe patients received sugammadex as neuromuscular blockade reversal |
| Standard | Active comparator | Drug: Neostigmine, AtropineThe patients received neostigmine + atropine as neuromuscular blockade reversal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA (american society of anesthesiologists) score ≤ III
- Patients underwent robotic assisted cystectomy
Key exclusion criteria (2 listed)
- Cerebrovascular disease
- BMI (body mass index) ≥ 30
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 |
|---|---|---|
| Sugammadex Injectable ProductPatients receive sugammadex at the end of the surgery | Drug | Sugammadex |
| Neostigmine, AtropinePatients receive neostigmine+atropine at the end of the surgery | Drug | Standard |
Primary outcome
Time to discharge from recovery room
Time frame: Up to 240 Minutes After recovery
Time between reversal administration and discharge from the recovery room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex Injectable Product and Neostigmine, Atropine in people with Anesthesiology Management, run by Regina Elena Cancer Institute at 2 sites 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 2 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 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Ester Forastiere, Chief (+39 06 52662449, ester.forastiere@ifo.gov.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discharge from recovery room (time frame: Up to 240 Minutes After recovery). 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 28 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.