Prostate CancerPhase 3RECIRNCT04854993
Recovery From dNMB Using Different Sugammadex Doses in Elderly Patients Undergoing Robot-assisted Prostatectomy
A Phase 3 study testing Sugammadex 6 mg/kg and Sugammadex 4 mg/kg in people with Prostate Cancer and Neuromuscular Blockade, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostate Cancer, Neuromuscular Blockade
- What is being tested?
- Sugammadex 6 mg/kg and Sugammadex 4 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jul 2021to 23 Sep 2022
- Phase
- Phase 3
- 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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- patient's age ≥65years
- prostate cancer
- robot-assisted laparoscopic radical prostatectomy (RALP)
Who cannot join
- inability to obtain written informed consent
- history of significant liver, renal or pulmonary diseases
- current smoking
- chronic or acute alcoholism
- known or suspected neuromuscular disorders
- family history of malignant hyperthermia
Show all 12Show fewer
- any pre-existing coagulopathy
- abnormal blood coagulation tests (including prothrombin time <70%; activated partial thromboplastin time >38 seconds and INR >1.20) or preoperative anticoagulant therapies
- BMI ≥30 Kg/m2
- known allergy or hypersensitivity to the drugs used in the study
- planned postoperative admission to intensive care unit.
- moderate neuromuscular block (TOF 1-3) at the end of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial
The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).
Read the detailed description
An increasing percentage of elderly patients with localized prostate cancer undergo RALP, due to the higher safety and feasibility of this minimally invasive surgical option compared to standard open procedure. This procedure is performed under deep neuromuscular block (dNMB) in order to guarantee an adequate working space. Induction and maintenance of the dNMB require neuromuscular monitoring and adequate reversal at the end of the intervention to prevent postoperative residual curarization (PORC). Sugammadex is the most attractive strategy to titrate reversal according to NMB monitoring data and to ensure a complete recovery of muscle function before extubation. In elderly patients, the risk of PORC and related postoperative complications is higher. For these reasons, we hypothesize that a dose of sugammadex increased by 50% compared to a standard dose could significantly shorten neuromuscular recovery time, extubation time, OR discharge time and PACU length of stay in elderly patients undergoing RALP.
- Conditions
- Prostate Cancer, Neuromuscular Blockade
- Being tested
- Sugammadex 6 mg/kg, Sugammadex 4 mg/kg
- Keywords
- sugammadex, elderly, recovery time, robotic surgery
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 6 mg/kgDrug
Also called MK-8616
i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB
Sugammadex 4 mg/kgDrug
Also called MK-8616
i.v. injection of a standard dose of sugammadex to reverse dNMB
| Study group | Role | What they receive |
|---|---|---|
| Increased dose of sugammadex | Experimental | A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery Receives: Drug: Sugammadex 6 mg/kg |
| Standard dose of sugammadex | Active comparator | A dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery Receives: Drug: Sugammadex 4 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular recovery time
Time from the end of sugammadex administration to train-of-four (TOF)=1
Measured: 5 minutes
Secondary outcomes (5)
Time to extubation
Time from neuromuscular reversal (TOF=1) to extubation
Measured: 10 minutes
Time to OR exit
Time from neuromuscular reversal (TOF=1) to exit from the operating room
Measured: 30 minutes
PACU length of stay
Duration of stay in the post-anaesthesia care unit
Measured: 2 hours
Hemodynamic parameters
Non-invasive blood pressure (mmHg) and heart rate (beats per minute) after sugammadex administration
Measured: up to discharge from post-anaesthesia care unit, an average of 2 hours
Respiratory function
Peripheral oxygen saturation (percentage) and respiratory rate (breaths per minute) after sugammadex administration
Measured: up to discarge from post-anaesthesia care unit, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start13 Jul 2021
- Primary completion20 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Aceto, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854993
- Sponsor's protocol ID
- 3764
- Other IDs
- 2020-004704-34
- Acronym
- RECIR
- Status last verified
- Jan 2022
- First submitted
- 14 Apr 2021
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery From Deep Neuromuscular Blockade Using Different Sugammadex Doses in Elderly Patients Undergoing Laparoscopic Robot-assisted Prostatectomy: a Prospective, Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04854993
- Acronym / sponsor ID
- RECIR / 3764
- Conditions
- Prostate Cancer, Neuromuscular Blockade
- Keywords
- sugammadex, elderly, recovery time, robotic surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 22 Apr 2021 (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.
The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).
Detailed description
An increasing percentage of elderly patients with localized prostate cancer undergo RALP, due to the higher safety and feasibility of this minimally invasive surgical option compared to standard open procedure. This procedure is performed under deep neuromuscular block (dNMB) in order to guarantee an adequate working space. Induction and maintenance of the dNMB require neuromuscular monitoring and adequate reversal at the end of the intervention to prevent postoperative residual curarization (PORC). Sugammadex is the most attractive strategy to titrate reversal according to NMB monitoring data and to ensure a complete recovery of muscle function before extubation. In elderly patients, the risk of PORC and related postoperative complications is higher. For these reasons, we hypothesize that a dose of sugammadex increased by 50% compared to a standard dose could significantly shorten neuromuscular recovery time, extubation time, OR discharge time and PACU length of stay in elderly patients undergoing RALP.
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 |
|---|---|---|
| Increased dose of sugammadex | Experimental | Drug: Sugammadex 6 mg/kgA dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery |
| Standard dose of sugammadex | Active comparator | Drug: Sugammadex 4 mg/kgA dose of 6 mg/kg of sugammadex will be given intravenously for deep neuromuscular block reversal at the end of surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patient's age ≥65years
- prostate cancer
- robot-assisted laparoscopic radical prostatectomy (RALP)
Key exclusion criteria (12 listed)
- inability to obtain written informed consent
- history of significant liver, renal or pulmonary diseases
- current smoking
- chronic or acute alcoholism
- known or suspected neuromuscular disorders
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 6 mg/kgAlso: MK-8616i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB | Drug | Increased dose of sugammadex |
| Sugammadex 4 mg/kgAlso: MK-8616i.v. injection of a standard dose of sugammadex to reverse dNMB | Drug | Standard dose of sugammadex |
Primary outcome
Neuromuscular recovery time
Time frame: 5 minutes
Time from the end of sugammadex administration to train-of-four (TOF)=1
5 secondary outcomes
Time to extubation
Time frame: 10 minutes
Time to OR exit
Time frame: 30 minutes
PACU length of stay
Time frame: 2 hours
Hemodynamic parameters
Time frame: up to discharge from post-anaesthesia care unit, an average of 2 hours
Respiratory function
Time frame: up to discarge from post-anaesthesia care unit, an average of 2 hours
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 25 Jan 2023.
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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.
Paola Aceto, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sugammadex 6 mg/kg and Sugammadex 4 mg/kg in people with Prostate Cancer and Neuromuscular Blockade, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 3 inclusion and 12 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 25 Jan 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neuromuscular recovery time (time frame: 5 minutes). 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 25 Jan 2023.