Time of a TOF Ratio >0,9Phase 4NCT03515694
Minimal Optimal Dose of Sugammadex in Elective Surgery
A Phase 4 study testing Sugammadex Injection [Bridion] in people with Time of a TOF Ratio >0,9, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Time of a TOF Ratio >0,9
- What is being tested?
- Sugammadex Injection [Bridion]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Apr 2018to 30 Sep 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women and men> 18 years of age Elective Surgery BMI <30, patients who gave consent to free and informed participation in writing
Who cannot join
- minor patients;
- patients refusing to sign consent;
- patients included in another protocol within 3 months;
- pregnant or nursing patients;
- patients with a history of allergy to Sugammadex;
- patients with known neuromuscular disease
- patients with renal or hepatic impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex
Read the detailed description
Design: monocentric, prospective, controlled, randomized, double-blind study Inclusion criteria: women and men> 18 years old, elective surgery, BMI <30, patients giving consent to free and informed participation in writing;
Exclusion criteria:
- minor patients;
- Patients refusing to sign the consent;
- Patients included in another protocol within 3 months;
- Pregnant or lactating patients;
- Patients with a history of allergy to Sugammadex;
- Patients with known neuromuscular disease;
- Patients with renal or hepatic impairment.
Course of the study :
- 40 patients will be recruited at the time of the anesthesia consultation and randomized to double blind in 8 groups (the day before surgery)
- All patients will benefit from general anesthesia. Anesthetic management (1- 3mg / kg / IV propofol, 0.2 μg / IV sufentanil, 0.6 mg / kg rocuronium and maintenance anesthesia with sevoflurane) will be standardized for all patients.
- Upon administration of rocuronium the acceleromyography transducer will be attached to the distal phalanx of the thumb, and repeated TOF stimulation will be applied to the ulnar nerve wrist at intervals of 15 seconds. Neuromuscular monitoring is continued until the end of the anesthesia.
- Once the first answer (1st twitch) appeared a dose of sugammadex will be administered according to the group whose patient was randomized: Test Groups Control Groups Group 1: Placebo + TOF 1 Group 1bis: Placebo + TOF2 Group 2: 0.5 mg / kg + TOF1 Group 2bis: 0.5 mg / kg + TOF2 Group 3: 1mg / kg + TOF1 Group 3bis: 1mg / kg + TOF2 Group 4: 2mg / kg + TOF 1 Group 4bis: 2mg / kg + TOF 2
- Then a standard dose of 4mg / kg will be administered at the end of the procedure before awakening to all patients who have signs of residual curarization (TOF ratio <0.9). The pharmacy will be responsible for preparing the different doses of sugammadex, the syringe will be carefully covered and packaged, will contain an equal volume so that the anesthetists do not know which group the patient belongs to. Data collection: In real time during the intervention by the anesthesiologist in charge of patient Method of Analysis: Analysis of intent-to-treat data
- Conditions
- Time of a TOF Ratio >0,9
- Being tested
- Sugammadex Injection [Bridion]
- Keywords
- Bridion, Sugammadex, TOF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex Injection [Bridion]Drug
Injection of 10mL of translucide solution
| Study group | Role | What they receive |
|---|---|---|
| Dose of 0mg/kg TOF1 | Placebo comparator | Not described Receives: Drug: Sugammadex Injection [Bridion] |
| Dose of 0mg/kg TOF2 | Placebo comparator | Not described Receives: Drug: Sugammadex Injection [Bridion] |
| Dose of 0 ,5mg/kg TOF1 | Experimental | Not described Receives: Drug: Sugammadex Injection [Bridion] |
| Dose of 0,5mg/kg TOF2 | Active comparator | Not described Receives: Drug: Sugammadex Injection [Bridion] |
| Dose of 1mg/kg TOF1 | Experimental | Not described Receives: Drug: Sugammadex Injection [Bridion] |
| Dose of 1mg/kg TOF2 | Active comparator | Not described Receives: Drug: Sugammadex Injection [Bridion] |
| Dose of 2mg/kg TOF1 | Experimental | Not described Receives: Drug: Sugammadex Injection [Bridion] |
| Dose of 2mg/kg TOF2 | Active comparator | Not described Receives: Drug: Sugammadex Injection [Bridion] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the recovery time of the ratio 0.9.
Evaluate the recovery time of the ratio 0.9.
Measured: 1 hour
Secondary outcomes (3)
Time of appearance of 4 responses to the TOF
Time of appearance of 4 responses to the TOF
Measured: 1 hour
Evaluate the four-to-four ratio <0.7 after total recovery.
Evaluate the four-to-four ratio <0.7 after total recovery.
Measured: 1 hour
Watch time at the recovery room.
Watch time at the recovery room.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start3 Apr 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time of a TOF Ratio >0,9Studies 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
- Model description
- Parallel, Double blind Monocentric Prospective Vs placebo
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy FERNANDEZ, Resident, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515694
- Sponsor's protocol ID
- BRIDION_ERASME
- Status last verified
- Apr 2018
- First submitted
- 23 Apr 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Optimal Dose of Sugammadex in Elective Surgery
- ClinicalTrials.gov ID
- NCT03515694
- Acronym / sponsor ID
- BRIDION_ERASME
- Conditions
- Time of a TOF Ratio >0,9
- Keywords
- Bridion, Sugammadex, TOF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 3 May 2018 (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.
Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex
Detailed description
Design: monocentric, prospective, controlled, randomized, double-blind study Inclusion criteria: women and men> 18 years old, elective surgery, BMI <30, patients giving consent to free and informed participation in writing;
Exclusion criteria:
- minor patients;
- Patients refusing to sign the consent;
- Patients included in another protocol within 3 months;
- Pregnant or lactating patients;
- Patients with a history of allergy to Sugammadex;
- Patients with known neuromuscular disease;
- Patients with renal or hepatic impairment.
Course of the study :
- 40 patients will be recruited at the time of the anesthesia consultation and randomized to double blind in 8 groups (the day before surgery)
- All patients will benefit from general anesthesia. Anesthetic management (1- 3mg / kg / IV propofol, 0.2 μg / IV sufentanil, 0.6 mg / kg rocuronium and maintenance anesthesia with sevoflurane) will be standardized for all patients.
- Upon administration of rocuronium the acceleromyography transducer will be attached to the distal phalanx of the thumb, and repeated TOF stimulation will be applied to the ulnar nerve wrist at intervals of 15 seconds. Neuromuscular monitoring is continued until the end of the anesthesia.
- Once the first answer (1st twitch) appeared a dose of sugammadex will be administered according to the group whose patient was randomized: Test Groups Control Groups Group 1: Placebo + TOF 1 Group 1bis: Placebo + TOF2 Group 2: 0.5 mg / kg + TOF1 Group 2bis: 0.5 mg / kg + TOF2 Group 3: 1mg / kg + TOF1 Group 3bis: 1mg / kg + TOF2 Group 4: 2mg / kg + TOF 1 Group 4bis: 2mg / kg + TOF 2
- Then a standard dose of 4mg / kg will be administered at the end of the procedure before awakening to all patients who have signs of residual curarization (TOF ratio <0.9). The pharmacy will be responsible for preparing the different doses of sugammadex, the syringe will be carefully covered and packaged, will contain an equal volume so that the anesthetists do not know which group the patient belongs to. Data collection: In real time during the intervention by the anesthesiologist in charge of patient Method of Analysis: Analysis of intent-to-treat data
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
- Model description
- Parallel, Double blind Monocentric Prospective Vs placebo
| Arm | Type | Receives |
|---|---|---|
| Dose of 0mg/kg TOF1 | Placebo comparator | Drug: Sugammadex Injection [Bridion] |
| Dose of 0mg/kg TOF2 | Placebo comparator | Drug: Sugammadex Injection [Bridion] |
| Dose of 0 ,5mg/kg TOF1 | Experimental | Drug: Sugammadex Injection [Bridion] |
| Dose of 0,5mg/kg TOF2 | Active comparator | Drug: Sugammadex Injection [Bridion] |
| Dose of 1mg/kg TOF1 | Experimental | Drug: Sugammadex Injection [Bridion] |
| Dose of 1mg/kg TOF2 | Active comparator | Drug: Sugammadex Injection [Bridion] |
| Dose of 2mg/kg TOF1 | Experimental | Drug: Sugammadex Injection [Bridion] |
| Dose of 2mg/kg TOF2 | Active comparator | Drug: Sugammadex Injection [Bridion] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women and men> 18 years of age Elective Surgery BMI <30, patients who gave consent to free and informed participation in writing
Key exclusion criteria (7 listed)
- minor patients;
- patients refusing to sign consent;
- patients included in another protocol within 3 months;
- pregnant or nursing patients;
- patients with a history of allergy to Sugammadex;
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 Injection [Bridion]Injection of 10mL of translucide solution | Drug | Dose of 0 ,5mg/kg TOF1, Dose of 0,5mg/kg TOF2, Dose of 0mg/kg TOF1, Dose of 0mg/kg TOF2, Dose of 1mg/kg TOF1, Dose of 1mg/kg TOF2, Dose of 2mg/kg TOF1, Dose of 2mg/kg TOF2 |
Primary outcome
Evaluate the recovery time of the ratio 0.9.
Time frame: 1 hour
Evaluate the recovery time of the ratio 0.9.
3 secondary outcomes
Time of appearance of 4 responses to the TOF
Time frame: 1 hour
Evaluate the four-to-four ratio <0.7 after total recovery.
Time frame: 1 hour
Watch time at the recovery room.
Time frame: 4 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 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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.
Wendy FERNANDEZ, Resident principal investigator
Erasme 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 4 study testing Sugammadex Injection [Bridion] in people with Time of a TOF Ratio >0,9, run by Erasme University Hospital at 1 site in Belgium.
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 7 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 15 Feb 2019. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
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?
Evaluate the recovery time of the ratio 0.9. (time frame: 1 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 15 Feb 2019.