Postoperative Residual CurarizationNCT05003024
Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Sugammadex
A study testing TOF SCAN and ITF in people with Postoperative Residual Curarization, run by Poitiers University Hospital at 1 site in France.
Trial summary
Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Residual Curarization
- What is being tested?
- TOF SCAN and ITF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2021to 23 Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA clinical status 1 to 3
- Informed consent obtained before anesthesia induction
Who cannot join
- ASA clinical status 4
- Emergency surgery; scheduled surgery in prone position,
- Hepatic or renal disease,
- BMI higher than 35,
- Allergy to rocuronium or sugammadex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Train of Four, Tetanus 50 Hz and Tetanus 100 Hz Recovery Following Rocuronium Induced Neuromuscular Block Reversed by Sugamamdex
Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio thershold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration.
Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by a specific reversal agent (sugammadex). The sugammedex will be injected once two muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (2mg/kg) in accordance with the clinical practice worldwide admitted.
Two questions have to be investigated. First, is this dose of sugammadex sufficient to allow a complete recovery of tetanus stimulations? Second, due to the pharmacological properties of sugammadex, does a recurarisation phenomenon occur following repeated tetanus stimulations? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.
- Conditions
- Postoperative Residual Curarization
- Being tested
- TOF SCAN, ITF
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF SCANDevice
For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand.
Once 2 contractions of the adductor pollicis muscle will be observed on the TOF Scan side following train of four stimulation, 2 mg/kg sugammadex will be injected. Train of four ratio (delivered every minute) will be recorded.
This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 5 times For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 23 minutes after sugammadex administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover.
ITFDevice
For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand.
On the ITF device side, 3 minutes after sugammadex administration, a tetanus 100 Hz stimulation will be done followed 2 minutes later by a tetanus 50 Hz stimulation.
This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 5 times For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 23 minutes after sugammadex administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover.
| Study group | Role | What they receive |
|---|---|---|
| TOF scan train of four ratio monitoring | Active comparator | Recovery of train of four ratio after sugammadex administration Receives: Device: TOF SCAN |
| ITF device tetanus stimulation monitoring | Experimental | Recovery of tetanus 100 Hz ratio after sugamamdex administration Receives: Device: ITF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the recovery of train of four ratio with the tetanus 100 Hz ratio following sugammadex administration to reverse the rocuronium induced neuromuscular bock at the end of the surgical procedure
delay following sugammadex administration to obtain a train of four ratio higher than 0.9 and a tetanus 100 Hz ratio higher than 0.9
Measured: 23 minutes after sugammadex administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start6 Sep 2021
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Residual CurarizationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003024
- Sponsor's protocol ID
- DECURATOF
- Status last verified
- Jan 2022
- First submitted
- 22 Jul 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Train of Four, Tetanus 50 Hz and Tetanus 100 Hz Recovery Following Rocuronium Induced Neuromuscular Block Reversed by Sugamamdex
- ClinicalTrials.gov ID
- NCT05003024
- Acronym / sponsor ID
- DECURATOF
- Conditions
- Postoperative Residual Curarization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 12 Aug 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.
Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio thershold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration.
Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by a specific reversal agent (sugammadex). The sugammedex will be injected once two muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (2mg/kg) in accordance with the clinical practice worldwide admitted.
Two questions have to be investigated. First, is this dose of sugammadex sufficient to allow a complete recovery of tetanus stimulations? Second, due to the pharmacological properties of sugammadex, does a recurarisation phenomenon occur following repeated tetanus stimulations? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOF scan train of four ratio monitoring | Active comparator | Device: TOF SCANRecovery of train of four ratio after sugammadex administration |
| ITF device tetanus stimulation monitoring | Experimental | Device: ITFRecovery of tetanus 100 Hz ratio after sugamamdex administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA clinical status 1 to 3
- Informed consent obtained before anesthesia induction
Key exclusion criteria (5 listed)
- ASA clinical status 4
- Emergency surgery; scheduled surgery in prone position,
- Hepatic or renal disease,
- BMI higher than 35,
- Allergy to rocuronium or 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 |
|---|---|---|
| TOF SCANFor each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand. Once 2 contractions of the adductor pollicis muscle will be observed on the TOF Scan side following train of four stimulation, 2 mg/kg sugammadex will be injected. Train of four ratio (delivered every minute) will be recorded. This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 5 times For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 23 minutes after sugammadex administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover. | Device | TOF scan train of four ratio monitoring |
| ITFFor each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand. On the ITF device side, 3 minutes after sugammadex administration, a tetanus 100 Hz stimulation will be done followed 2 minutes later by a tetanus 50 Hz stimulation. This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 5 times For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 23 minutes after sugammadex administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover. | Device | ITF device tetanus stimulation monitoring |
Primary outcome
To compare the recovery of train of four ratio with the tetanus 100 Hz ratio following sugammadex administration to reverse the rocuronium induced neuromuscular bock at the end of the surgical procedure
Time frame: 23 minutes after sugammadex administration
delay following sugammadex administration to obtain a train of four ratio higher than 0.9 and a tetanus 100 Hz ratio higher than 0.9
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 Jan 2022.
- Individual participant dataSharing planned: No
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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.
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 TOF SCAN and ITF in people with Postoperative Residual Curarization, run by Poitiers University Hospital at 1 site in France.
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 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 Jan 2022. 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 France. 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?
To compare the recovery of train of four ratio with the tetanus 100 Hz ratio following sugammadex administration to reverse the rocuronium induced neuromuscular bock at the end of the surgical procedure (time frame: 23 minutes after sugammadex administration). 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 Jan 2022.